Appendix A. Search Strategies 

Ovid: Search Form EMBASE 

<1980 to 2004 Week 12>

# Search History Results 

1 exp soybean protein/ 1247 

2 exp soybean/ 4388 

3 exp isoflavone/ 815 

4 exp casein/ 3830 

5 exp genistein/ 4989 

6 soy$.mp. 13750 

7 tofu.mp. 133 

8 tempeh.mp. 27 

9 casein$.mp. 11015 

10 isoflavone$.mp. 1962 

11 genistein$.mp. 5759 

12 daidzein$.mp. or exp DAIDZEIN/ 1272 

13 exp GLYCITEIN/ or glycitein$.mp. 102 

14 aglycone$.mp. 1811 

15 or/1-14 31218 

16 limit 15 to human 10162 

17 limit 16 to english language 9578 

18 limit 17 to (adult <18 to 64 years> or aged <65+ years>) 1420 

19 17 not 18 8158 

20 limit 19 to (infant <to one year> or child <unspecified age> or preschool 

child <1 to 6 years> or school child <7 to 12 years> or adolescent <13 to 

17 years>) 839 

21 17 not 20 8739 

22 exp controlled study/ 1724288 

23 exp clinical study/ 2696150 

24 double blind procedure/ 51005 

25 single blind procedure/ 4636 

26 Crossover Procedure/ 14692 

27 or/22-26 3787687 

28 21 and 27 4532 

29 exp in vivo study/ 3875902 

30 28 not 29 2182 

31 exp in vitro study/ 2038097 

32 30 and 31 1893 

33 28 not 32 2639 

A-1
Appendix A. Search Strategies (continued) 

Ovid: Search Form Ovid MEDLINE(R) 

 <1966 to March Week 5 2004>

# Search History Results 

1 exp soybean proteins/ 2636 

2 exp soybeans/ 10386 

3 exp isoflavones/ 6991 

4 exp caseins/ 9648 

5 exp genistein/ 3130 

6 soy.mp. 5149 

7 soya.mp 1635 

8 tofu.mp. 152 

9 tempeh.mp. 32 

10 casein$.tw. 14637 

11 soybean$.mp. 17685 

12 soyabean$.mp. 313 

13 isoflavone$.mp. 3814 

14 genistein$.mp. 5387 

15 daidzein$.mp. 918 

16 glycitein$.mp. 70 

17 aglycone$.mp. 1890 

18 or/1-17 48150 

19 limit 18 to human 13705 

20 limit 19 to english language 12541 

21 limit 20 to all adult <19 plus years> 2516 

22 20 not 21 10025 

23 limit 22 to all child <0 to 18 years> 1262 

24 20 not 23 11279 

25 limit 24 to (addresses or bibliography or biography or case reports or 

congresses or consensus development conference or consensus 

development conference, nih or dictionary or directory or editorial or 

festschrift or government publications or interview or lectures or legal 

cases or legislation or letter or news or newspaper article or patient 

education handout or periodical index) 400 

26 24 not 25 10879 

27 follow-up studies/ 280686 

28 (follow-up or followup).tw. 297836 

29 exp Case-Control Studies/ 250582 

30 (case adj20 control).tw. 38163 

31 exp Longitudinal Studies/ 456180 

32 longitudinal.tw. 54945 

33 exp Cohort Studies/ 487498 

34 cohort.tw. 58541 

A-2
Appendix A. Search Strategies (continued) 

35 (random$ or rct).tw. 280359 

36 exp Randomized Controlled Trials/ 31513 

37 exp random allocation/ 50295 

38 exp Double-Blind Method/ 77373 

39 exp Single-Blind Method/ 7937 

40 randomized controlled trial.pt. 186803 

41 clinical trial.pt. 378381 

42 (clin$ adj trial$).tw. 76518 

43 ((singl$ or doubl$ or trebl$ or tripl$) adj (blind$ or mask$)).tw. 74006 

44 exp PLACEBOS/ 22848 

45 placebo$.tw. 83019 

46 exp Research Design/ 177697 

47 exp Evaluation Studies/ 480708 

48 exp Prospective Studies/ 170854 

49 exp Comparative Study/ 1106306 

50 or/27-49 2492656 

51 26 and 50 2650 

A-3
Appendix A. Search Strategies (continued) 

Ovid: Search Form Ovid MEDLINE(R) 

 <1966 to March Week 5 2004>

# Search History Results 

1 exp soybean proteins/ 2644 

2 exp soybeans/ 10410 

3 exp isoflavones/ 7023 

4 exp caseins/ 9657 

5 exp genistein/ 3139 

6 soy.mp. 5166 

7 soya.mp 1637 

8 tofu.mp. 152 

9 tempeh.mp. 32 

10 casein$.tw. 14662 

11 soybean$.mp. 17720 

12 soyabean$.mp. 315 

13 isoflavone$.mp. 3839 

14 genistein$.mp. 5402 

15 daidzein$.mp. 923 

16 glycitein$.mp. 70 

17 aglycone$.mp. 1896 

18 or/1-17 48260 

19 limit 18 to human 13744 

20 limit 19 to english language 12576 

21 limit 20 to all adult <19 plus years> 2524 

22 20 not 21 10052 

23 limit 22 to all child <0 to 18 years> 1264 

24 20 not 23 11312 

25 limit 24 to (addresses or bibliography or biography or case reports or 

congresses or consensus development conference or consensus 

development conference, nih or dictionary or directory or editorial or 

festschrift or government publications or interview or lectures or legal 

cases or legislation or letter or news or newspaper article or patient 

education handout or periodical index) 401 

26 24 not 25 10911 

27 follow-up studies/ 281231 

28 (follow-up or followup).tw. 298732 

29 exp Case-Control Studies/ 251543 

30 (case adj20 control).tw. 38324 

31 exp Longitudinal Studies/ 457323 

32 longitudinal.tw. 55119 

33 exp Cohort Studies/ 488857 

34 cohort.tw. 58921 

A-4
Appendix A. Search Strategies (continued) 

35 (random$ or rct).tw. 281428 

36 exp Randomized Controlled Trials/ 31687 

37 exp random allocation/ 50387 

38 exp Double-Blind Method/ 77581 

39 exp Single-Blind Method/ 7981 

40 randomized controlled trial.pt. 187367 

41 clinical trial.pt. 379438 

42 (clin$ adj trial$).tw. 76848 

43 ((singl$ or doubl$ or trebl$ or tripl$) adj (blind$ or mask$)).tw. 74193 

44 exp PLACEBOS/ 22885 

45 placebo$.tw. 83266 

46 exp Research Design/ 178254 

47 exp Evaluation Studies/ 482188 

48 exp Prospective Studies/ 178254 

49 exp Comparative Study/ 1109381 

50 or/27-49 2499998 

51 26 and 50 2663 

52 miso.tw. 417 

53 53 not 18 354 

54 limit 53 to human 97 

55 limit 54 to english language 84 

56 limit 55 to (all adult <19 plus years> or adolescent <13 to 18 years>) 35 

57 55 not 56 49 

58 limit 57 to (all infant <birth to 23 months> or preschool child <2 to 5 

years> or child <6 to 12 years>) 0

59 limit 58 to (addresses or bibliography or biography or case reports or 

congresses or consensus development conference or consensus 

development conference, nih or dictionary or directory or editorial or 

festschrift or government publications or interview or lectures or legal 

cases or legislation or letter or news or newspaper article or patient 

education handout or periodical index) 1 

60 55 not 61 83 

61 60 and 50 47 

62 misonidazole.tw 1196 

63 61 not 62 10 

A-5
Design

Submit This Section

Randomized? ND gfedc

nmlkj Randomized 

nmlkj Non-randomized 

nmlkj Unclear (Explain:) 

Multiple vs Single Cohorts ND gfedc

nmlkj Multiple study arms/cohorts (Comment:) 

nmlkj Single study arm/cohort (Comment:) 

----------------------------------------

Submit This Section

What is the specific study design? ND gfedc

nmlkj Randomized Parallel 

nmlkj Randomized Cross-over 

nmlkj Randomized Factorial Design 

nmlkj Non-Randomized Controlled trial 

nmlkj Non-Randomized Non-Controlled trial -- Single soy cohort 

nmlkj Non-Randomized Non-Controlled trial -- Multiple cohorts (all soy) 

nmlkj Other or Mixed (Describe:) 

Comments about Study Design:

----------------------------------------

Submit This Section

Blinding

Was study: ND gfedc

nmlkj Not blinded 

nmlkj "Single Blind" 

nmlkj "Double Blind" 

nmlkj Other: 

Page 1 of 26
Comments about Blinding

----------------------------------------

Submit This Section

Randomization Quality

If "Randomized" Trial:

Did authors explicitly state that study was "randomized"? ND gfedc

nmlkj Yes 

nmlkj No 

What was method of randomization? ND gfedc

nmlkj Not reported (only stated "randomized") 

nmlkj Reported (What was method?) 

-----------------------------------

Submit This Section

Allocation Concealment Quality

If Randomized trial:

Allocation Concealment = Method by which allocation (which cohort a subject was assigned to) is concealed 

from subject, caretaker, and all others involved in study. The purpose is to prevent subjects being allocated to 

one or another cohort based on any subject or researcher characteristics or biases (such as peaking into 

envelope to give sicker patients active treatment because "they need it more.")

Examples (of both good and bad allocation concealment) = Central randomization site, Pharmacyrandomization, Opaque envelope, Alternating, List

What was method of Allocation Concealment? ND gfedc

nmlkj None reported 

nmlkj Reported (What was method?) 

-----------------------------------

Submit This Section

Overall Study Design Quality

Also consider reporting of drop-outs/withdrawals and actual drop-out rate.

Is overall quality of Study Design: ND gfedc

nmlkj Good 

nmlkj Fair 

nmlkj Poor 

Why?

Do you find substantial biases related to Study Design: ND gfedc

Page 2 of 26
nmlkj Yes 

nmlkj No 

What?

Submit This Section

Characteristics

Submit This Section

Check all responses that apply. Complete all sections fully. Check ND if data not reported

Country in which study conducted (where subjects live) ND gfedc

gfedc US 

gfedc Canada 

gfedc China 

gfedc France 

gfedc Germany 

gfedc Hong Kong 

gfedc Japan 

gfedc Netherlands 

gfedc UK (England, Scotland, Wales, Northern Ireland; NOT Ireland) 

gfedc Other(s) [Separate countries with commas]: 

gfedc ND 

Number of Sites (enter # or "multiple"): ND gfedc

Funding source: ND gfedc

gfedc Government 

gfedc Industry (specify which): 

gfedc Private -- non-industry (specify which): 

gfedc Hospital or University 

gfedc Unclear (specify which): 

gfedc ND 

Duration of Intervention: ND Choose gfedc

Study Duration Range (if applicable) to ND gfedc

----------------------------------------

Submit This Section

Page 3 of 26
Is overall quality of Study Characteristics: ND gfedc

nmlkj Good 

nmlkj Fair 

nmlkj Poor 

Why?

Do you find substantial biases related to Study Characteristics? ND gfedc

nmlkj Yes 

nmlkj No 

What?

Submit This Section

Eligibility

Submit This Section

Inclusion Criteria:

Exclusion Criteria:

Comment about Eligibility Criteria:

----------------------------------------

Submit This Section

At baseline, Were subjects...? ND gfedc

gfedc Men 

gfedc Pre-menopausal Women 

gfedc Post-menopausal Women 

gfedc Women on Hormone Replacement Therapy (HRT) 

Page 4 of 26
gfedc On hormone-blocking treatment (eg, for cancer) 

At baseline, Were subjects...? ND gfedc

nmlkj Women on Hormone Replacement Therapy (HRT) 

nmlkj On hormone-blocking treatment (eg, for cancer) 

nmlkj Neither 

-----

If necessary, for each condition, What was the reported definition?

Pre-Menopause? 

Post-Menopausal? 

Menopause 

HRT 

Hormone-blocking treatment 

Comment about Definitions:

----------------------------------------

Submit This Section

Is overall quality of Eligibility: ND gfedc

nmlkj Good 

nmlkj Fair 

nmlkj Poor 

Why?

Do you find substantial biases related to Eligibility Criteria? ND gfedc

nmlkj Yes 

nmlkj No 

What?

Submit This Section

Population

Submit This Section

Page 5 of 26
Subjects and Controls

(Provide largest #, if multiple analyses reported. If possible, number enrolled should be based on Intention-toTreat principle: All subjects who were randomized or put into a treatment cohort)

Control (No intervention or Placebo) -- Number enrolled: ND gfedc

IGNORE NON-SOY, NON-CONTROL ARMS. ASK ETHAN OR JOSEPH IF UNCLEAR.

------

Treatment Arm 1 or Single Cohort -- Simple description: ND gfedc

Treatment Arm 1 or Single Cohort -- Number enrolled ND gfedc

------

Treatment Arm 2 -- Simple description: ND gfedc

Treatment Arm 2 -- Number enrolled: ND gfedc

------

Treatment Arm 3 -- Simple description: ND gfedc

Treatment Arm 3 -- Number enrolled: ND gfedc

------

Treatment Arm 4 -- Simple description: ND gfedc

Treatment Arm 4 -- Number enrolled: ND gfedc

------

More Arms: Number each arm, Describe, and give Sample Size

------

Were the number of enrolled subjects and drop-outs explicitly and clearly reported? 

gfedc ND 

nmlkj Yes 

nmlkj No 

Were the reasons for drop-outs/withdrawals clearly stated? ND gfedc

nmlkj Yes 

nmlkj No 

Reason for dropouts, withdrawals, etc.

Comment about Number Enrolled etc.:

----------------------------------------

Submit This Section

Demographics etc.

Page 6 of 26
(Choose one group of subjects to report on. Choose COMBINED over SINGLE soy cohort. If necessary, Choose 

LARGEST soy cohort.)

...

For each variable, answer whether there is a difference among treatment groups. If yes, describe in Comments 

box below.

Which cohort/group of subjects are baseline data reported for? ND gfedc

nmlkj Combined (all subjects) 

nmlkj Soy (only single soy cohort) 

nmlkj Largest (by N) Soy cohort 

nmlkj Specific (Other) Soy cohort (describe:) 

------

Are statistical analyses (eg, p-values) reported comparing cohorts at BASELINE?

nmlkj Yes 

nmlkj No 

------

AGE

Is there a Difference in Age among cohorts?

nmlkj Yes (describe below) 

nmlkj No 

nmlkj ND / NA / Unclear 

Mean/Median Age: ND Choose 1 gfedc

+/- SD/SE: ND Choose 1 gfedc

Age Range: to ND gfedc

------

SEX

Is there a Difference in Sex Ratio among cohorts?

nmlkj Yes (describe below) 

nmlkj No 

nmlkj ND / NA / Unclear 

Sex: Male (%): ND gfedc

------

SMOKING

Is there a Difference in Smoking Rates among cohorts?

nmlkj Yes (describe below) 

nmlkj No 

nmlkj ND / NA / Unclear 

Smokers (%): ND gfedc

------

WEIGHT/BMI

Is there a Difference in Body Weight (BMI, Kg) among cohorts?

Page 7 of 26
nmlkj Yes (describe below) 

nmlkj No 

nmlkj ND / NA / Unclear 

Mean Weight/BMI: ND Choose 1 gfedc

------

RACE

Is there a Difference in Race among cohorts?

nmlkj Yes (describe below) 

nmlkj No 

nmlkj ND / NA / Unclear 

Race (%, Put Whole Number only in text box): ND gfedc

gfedc White/European 

gfedc Black/African-American/etc. 

gfedc Asian 

gfedc Hispanic 

gfedc Other 1 (% here, describe below) 

gfedc Other 2 (% here, describe below) 

gfedc Other 3 (% here, describe below) 

gfedc ND 

------

OTHER RELEVANT BASELINE DEMOGRAPHIC VARIABLES

Do Not Include Variable If It Is An Outcome Being Analyzed

-----

VARIABLE 1

Variable 

Is there a Difference in Variable 1 among cohorts?

nmlkj Yes (describe below) 

nmlkj No 

nmlkj ND / NA / Unclear 

Variable 1 Data ND gfedc

+/- SD/SE ND Choose 1 gfedc

Variable 1 Range: to ND gfedc

------

VARIABLE 2

Variable 

Is there a Difference in Variable 2 among cohorts?

nmlkj Yes (describe below) 

nmlkj No 

Page 8 of 26
nmlkj ND / NA / Unclear 

Variable 2 Data ND gfedc

+/- SD/SE ND Choose 1 gfedc

Variable 2 Range: to ND gfedc

------

VARIABLE 3

Variable 

Is there a Difference in Variable 3 among cohorts?

nmlkj Yes (describe below) 

nmlkj No 

nmlkj ND / NA / Unclear 

Variable 3 Data ND gfedc

+/- SD/SE ND Choose 1 gfedc

Variable 3 Range: to ND gfedc

------

COMMENTS

Comments about Demographics etc.:

----------------------------------------

Submit This Section

Is overall quality of Population data/reporting: ND gfedc

nmlkj Good 

nmlkj Fair 

nmlkj Poor 

Why?

Do you find substantial biases related to Population: ND gfedc

nmlkj Yes 

nmlkj No 

What?

Submit This Section

Page 9 of 26
Confounders

Submit This Section

Other Confounders etc.

CONCOMITANT MEDICATIONS

Is there a Difference in Medication Use among cohorts?

nmlkj Yes (describe below) 

nmlkj No 

nmlkj ND / NA / Unclear 

If YES, What?

-----------------------

BASELINE DIET FACTORS

Difference in Baseline Diet among cohorts? ND gfedc

nmlkj Yes (describe below) 

nmlkj No 

nmlkj ND / NA / Unclear 

If Yes, What?

.....Type in All or Subgroup (check box also) ND gfedc

gfedc High soy diet 

gfedc Low soy diet 

gfedc Vegetarian diet 

gfedc Low fat diet 

gfedc High fat diet 

gfedc Other1 

gfedc Other2 

gfedc Other3 

Description of Baseline Diets:

Comments about Other Confounders:

----------------------------------------

Page 10 of 26
Submit This Section

Is overall quality of Confounder data/reporting: ND gfedc

nmlkj Good 

nmlkj Fair 

nmlkj Poor 

Why?

Do you find substantial biases related to Confounders? ND gfedc

nmlkj Yes 

nmlkj No 

What?

Submit This Section

Applicability

Submit This Section

Sample representative of...

nmlkj Men 

nmlkj Both Men and Women (everyone) 

nmlkj Premenopausal Women 

nmlkj Postmenopausal Women 

nmlkj Both Pre- & Postmenopausal Women 

nmlkj Other 

that are ND gfedc

gfedc Representative of the General Population 

gfedc "Healthy" 

gfedc At Increased Risk of Bone Disease (or have disease) 

gfedc At Increased Risk of CVD (including BP,Chol or have CVD)) 

gfedc At Increased Risk of DM (or have DM) 

gfedc At Increased Risk of Cancer 

gfedc Other 

If Other, or if a variant of above, Describe

Page 11 of 26
Within Above Category, What is Applicability

nmlkj I: Sample representative of total population relevant to category 

nmlkj II: Sample is an important sub-group of reference population 

nmlkj III: Sample represents only a narrow, atypical subgroup of reference population 

nmlkj ND: Cannot categorize because of incomplete demographic or other data 

Other Comments about Applicability:

Submit This Section

Control Arm

Submit This Section

What was the authors' description of Control or Placebo

What was used as Control / "Placebo" ND gfedc

gfedc Milk protein/Casein 

gfedc Non-fat Milk 

gfedc Other Milk, describe 

gfedc Other protein (non-fat), Which? 

gfedc Other protein (with fat), Which? 

gfedc Other, Which? 

How much protein per day? ND gfedc

How much product per day (if necessary)? ND gfedc

Comments on Control/Placebo source:

----------------------------------------

Submit This Section

Is overall quality of Control data/reporting: ND gfedc

nmlkj Good 

Page 12 of 26
nmlkj Fair 

nmlkj Poor 

Why?

Do you find substantial biases related to Control/Placebo? ND gfedc

nmlkj Yes 

nmlkj No 

What?

Submit This Section

Soy Description

Submit This Section

DUPLICATE THIS SECTION FOR EACH TREATMENT ARM

Do Not Use The Template (titled Tx Arm No.) to Enter Data.

Title each new section by an appropriate Brief Description (eg, Soy Milk, ISP+Isoflavone,ISP-Isoflavone)

Also name Section ID the same

Treatment Arm Name 

------------------------------------

Submit This Section

What was the authors' description of Soy intervention?

Was Intervention a branded supplement? ND gfedc

nmlkj Yes 

nmlkj No 

If Yes, which? ND gfedc

nmlkj Abacor 

nmlkj Supro 

nmlkj SOYSELECT 

nmlkj TakeCare 

nmlkj Phytosoya 

Page 13 of 26
nmlkj Other, which? 

What was/were the source(s) of Soy? ND gfedc

gfedc Soy-based Diet 

gfedc Whole Soybean (or equivalent) 

gfedc Tofu 

gfedc Textured Soy Protein (meat substitute) 

gfedc Soy Milk (not soy protein drink) 

gfedc Other Dietary Soy Product, Which? 

gfedc Isolated Soy Protein w/Isoflavones 

gfedc Isolated Soy Protein w/o Isoflavones 

gfedc Isolated Soy Protein, unclear re: Isoflavones 

gfedc Soy Isoflavones (without protein) 

gfedc Other Soy Product Supplement, Which? 

Comments on Soy source:

----------------------------------------

How many grams of Soy Protein per day? 

How many mg of Genistein per day? 

How many mg of Daidzein per day? 

How many mg of Other Isoflavone per day? Name isoflavone below 

How many mg of Total Isoflavones per day? 

How many grams total soy product (dietary or supplement) per day, if different than above 

(eg, grams of tofu) 

Submit This Section

For all interventions

Is overall quality of Intervention data/reporting: ND gfedc

nmlkj Good 

nmlkj Fair 

nmlkj Poor 

Why?

Do you find substantial biases related to Treatments: ND gfedc

nmlkj Yes 

nmlkj No 

Page 14 of 26
What?

Submit This Section

Outcomes

Submit This Section

Submit This Section

OUTCOME CATEGORY

What types of Outcomes are reported in study?

gfedc Clinical Outcome 

gfedc Intermediate Outcome 

---------------------------------------

Submit This Section

CLINICAL OUTCOMES

Check box and describe

gfedc Menopausal Symptoms Description: 

gfedc Clinical Outcome 1 Description: 

gfedc Clinical Outcome 2 Description: 

gfedc Clinical Outcome 3 Description: 

gfedc Clinical Outcome 4 Description: 

-----

Comment about Clinical Outcomes

------------------------------------

Submit This Section

INTERMEDIATE OUTCOMES

Include even if data not reported (eg," BP unchanged, data not reported)")

CVD RELATED (*** = to be data extracted)

Lipids:

Page 15 of 26
gfedc Total Cholesterol *** 

gfedc LDL *** 

gfedc HDL *** 

gfedc Triglycerides *** 

gfedc Lp(a) *** 

gfedc Apo A-1 

gfedc Apo B/B-100 

gfedc Apo C-III 

gfedc Apo E 

gfedc Remnant-Like Particles (RLP) 

gfedc Free or Non-Esterified Fatty Acids 

Blood Pressure:

gfedc Systolic (SBP) *** 

gfedc Diastolic (DBP) *** 

gfedc Mean Arterial Pressure (MAP) *** [if ND on SBP/DBP] 

Vascular Function

gfedc Peripheral Endothelial Function (Brachial artery/FMD/FBF) *** 

gfedc Coronary Endothelial Function *** 

gfedc Systemic Arterial Compliance *** 

Miscellaneous CVD Risk Factors Being Included

gfedc C-reactive protein (CRP) *** 

gfedc Homocysteine *** 

gfedc Oxidized LDL/Lipids/Dienes/TBAR (Ask Ethan if unsure) *** 

Other CVD Serum Markers:

gfedc E-Selectin 

gfedc Endothelin 1 

gfedc Factor VII (any type) 

gfedc Factor VIII (any type) 

gfedc Factor XII (any type) 

gfedc Fibrinogen 

gfedc ICAM 

gfedc Interleukin 2R 

gfedc Interleukin 6 

gfedc Nitrous Oxide (NO) 

gfedc P-Selectin 

gfedc Thrombomodulin 

gfedc VCAM 

Page 16 of 26
gfedc von Willebrand Factor (vWF, Factor VIII:Ag) (any type) 

gfedc OTHER SERUM CVD MARKER 1 

gfedc OTHER SERUM CVD MARKER 2 

gfedc OTHER SERUM CVD MARKER 3 

Other Diagnostic Tests

gfedc Ankle Brachial Index 

gfedc Bleeding Time 

gfedc Carotid Doppler/Ultrasound 

gfedc Carotid Intima Media Thckness (IMT) aka Doppler 

gfedc Coronary Arteriography 

gfedc ECG parameters 

gfedc Echocardiography 

gfedc Exercise Tolerance Test (treadmill, bicycle) 

gfedc Heart Rate Variability 

gfedc Platelet Aggregation 

gfedc OTHER CVD TEST 1 

gfedc OTHER CVD TEST 2 

gfedc OTHER CVD TEST 3 

------------------------------------

Diabetes related:

gfedc Hgb A1c (Glycohemoglobin) *** 

gfedc Fasting Glucose/Blood Sugar (FBS) *** 

gfedc Insulin:Glucose Ratio (not just insulin alone) *** 

gfedc Insulin Sensitivity Measure (ask Athina, Joseph, or Ethan if unclear) *** 

gfedc OGTT (oral glucose tolerance test) *** 

gfedc Insulin [DO NOT EXTRACT Insulin or Insulin OGTT] 

gfedc Glucagon [DO NOT EXTRACT] 

Kidney Outcomes:

gfedc GFR or Creatinine Clearance 

gfedc Uric Acid clearance/metabolism 

gfedc Serum Creatinine 

gfedc Proteinuria 

gfedc Albuminuria 

gfedc BUN 

gfedc Other Kidney Outcome (enter): 

Osteoporosis:

gfedc Bone Mineral Density (BMD) 

Page 17 of 26
gfedc Bone Mineral Content (BMC) 

gfedc Serum bone specific alkaline phosphatase (BAP) 

gfedc Serum osteocalcin (OC) 

gfedc Urine deoxypyridinoline (D-PYR) 

gfedc Urine pyridinoline (PYR) 

gfedc Type 1 Collagen cross-linked N-teleopeptide (NTx) 

gfedc Urine Calcium 

gfedc Bone Stiffness 

gfedc Other Bone Outcome (enter): 

Women's Health:

gfedc Menstrual Cycle Length 

gfedc Vaginal Cytology Maturation Index 

gfedc Endometrial Thickness 

gfedc Endometrial Histology 

gfedc Mammographic Density 

gfedc Other GYN Outcome (enter): 

SEX HORMONES:

Serum

gfedc SHBG (Sex Hormone Binding Globulin) 

gfedc LH 

gfedc FSH 

gfedc Estradiol 

gfedc Estrone 

gfedc Estrone Sulfate 

gfedc Progesterone 

gfedc Prolactin 

gfedc Testosterone 

gfedc Androstenedione 

gfedc DHEA/DHEAS 

gfedc Other Serum Sex Hormone Outcome (enter): 

Urine

gfedc 2-hydroxyestrone 

gfedc 16-alpha-hydroxyestrone 

gfedc Equol 

gfedc Other Urine Sex Hormone Outcome (enter): 

Cancer Intermediate Outcomes:

gfedc PSA levels 

Page 18 of 26
gfedc 5-OHmdU in DNA from nucleated blood cells 

gfedc Other Intermediate Cancer Outcomes (enter): 

Other Endocrine:

gfedc T3 (triiodothyroxine) 

gfedc T4 (thyroxine) 

gfedc Thryoid Binding Globulin (TBG) 

gfedc TSH 

gfedc Parathyroid Hormone 

gfedc Cortisol 

gfedc IGF-1 

gfedc Other Endocrine Outcomes (enter): 

------------------------------------

Any Other Outcomes:

Submit This Section

------------------------------------

Comment about Intermediate Outcomes

Submit This Section

ADVERSE EVENTS/DRUG INTERACTIONS

Are Adverse Events, Side Effects, Complications DUE TO Soy Supplement or Diet 

Reported? ND gfedc

nmlkj Yes 

nmlkj No 

If YES, What was reported?

Are DRUG INTERACTIONS between soy and medications reported? ND gfedc

nmlkj Yes 

nmlkj No 

If YES, What was reported?

Submit This Section

Page 19 of 26
Results TEMPLATE (continuous d

Submit This Section

Duplicate this section for each OUTCOME. Name and ID new section "Outcome". NO SPACES IN NAME.

Was this outcome reported as a Primary or Secondary Outcome? ND gfedc

nmlkj Primary Outcome 

nmlkj Secondary Outcome 

nmlkj Unclear (Desribe why below) 

Why unclear?

------

Description of Outcome (if 

necessary): 

Outcome Units (type in if not in menu. Use Dichotomous form if N or % 

subjects) ND mg/dL gfedc

-------------------------------------

Submit This Section

Treatment Arms

Check box and describe

gfedc Tx Arm 1 Description: 

gfedc Tx Arm 2 Description: 

gfedc Tx Arm 3 Description: 

gfedc Tx Arm 4 Description: 

-----

Submit This Section

Outcomes

The results reported for this outcome are the: ND gfedc

nmlkj Mean 

nmlkj Median 

Page 20 of 26
The variance unit reported for this outcome is: ND gfedc

nmlkj SD 

nmlkj SE or SEM 

nmlkj Unclear SD or SE 

The ranges reported for this outcome are: ND gfedc

nmlkj 95% CI (confidence interval) 

nmlkj Total Range 

nmlkj Inter-Quartile Range (IQR) 

Baseline Data

n Baseline Value SD or SE Value

Tx Arm 1

Tx Arm 2

Tx Arm 3

Tx Arm 4

Control

Comment about Baseline Data

Report number of FINAL subjects analyzed, even if the same as baseline (to avoid confusion)

Follow-up / Final Data or Clinical Event Data

n Final Value SD or SE Value

Tx Arm 1

Tx Arm 2

Tx Arm 3

Tx Arm 4

Control

Comment about Final Data

Submit This Section

Reported Within-Treatment Difference:

Reported data re: difference in outcome level between final and baseline times.

NOT differences between interventions.

Reported value for FINAL value minus BASELINE value.

Page 21 of 26
Be Careful: Studies can report a decrease as either a positive or negative number (and vice versa).

Report Real change (FINAL - BASELINE).

No need to repeat P-value for within-treatment difference if reported in Final table.

Within-Treatment Difference Data

Reported difference SD or SE Value Range

Tx Arm 1

Tx Arm 2

Tx Arm 3

Tx Arm 4

Control

Comment about Within-Treatment Difference

----- ----- ----- ----- ----- -----

Submit This Section

Reported Difference of FINAL Treatment vs Control (Cross-over Studies ONLY):

Reported data re: difference between FINAL levels of intervention and control.

NOT net difference (see below)

Tx(final) - Control(Final) 

ONLY FOR CROSS-OVER STUDIES

Reported Final difference

Reported Difference SD or SE Value Range

Tx Arm 1 - Control

Tx Arm 2 - Control

Tx Arm 3 - Control

Tx Arm 4 - Control

Comment about Difference between Final Values

----- ----- ----- ----- ----- -----

Submit This Section

Reported NET Treatment vs Control Difference:

Reported data re: difference between CHANGE in outcome level between intervention and control.

NOT difference between final outcome levels.

Page 22 of 26
[Tx(final) - Tx(baseline)] - [Control(Final) - Control(Baseline)]

Reported Net difference

Reported Difference SD or SE Value Range

Tx Arm 1 - Control

Tx Arm 2 - Control

Tx Arm 3 - Control

Tx Arm 4 - Control

Comment about Between-Treatment Difference

----- ----- ----- ----- ----- -----

Submit This Section

Statistical Significance

Comment about Statistical Significances

----- ----- ----- ----- ----- -----

Submit This Section

Results TEMPLATE (dichotomous data or OR/RR)

Submit This Section

DUPLICATE THIS SECTION FOR EACH RESULT SECTION.

This will include both treatment and control arm

THERE SHOULD BE ONE NEW SECTION FOR EACH "OUTCOME."

Title each new Dichotomous Result section with "Outcome". NO SPACES IN NAME.

Submit This Section

Answer the following question Once only for each outcome

Was this outcome reported as a Primary or Secondary Outcome? ND gfedc

nmlkj Primary Outcome 

nmlkj Secondary Outcome 

Page 23 of 26
nmlkj Unclear (Desribe why below) 

Why unclear?

------

Description of Outcome (if 

necessary): 

------

Description of Tx Arm 1: 

Description of Tx Arm 2: 

Description of Tx Arm 3: 

Description of Tx Arm 4: 

-------------------------------------

Submit This Section

2x2 Data

PREFERABLY ENTER NUMBER OF SUBJECTS. IF NOT REPORTED ENTER % OF SUBJECTS IN SECTION 

BELOW.

NUMBER

Enter NUMBER of Subjects That Belong in Each Cell

Enter EITHER (number with outcome AND number w/o outcome) OR (number with outcome AND total (denominator

-----

2 x 2 Number

Number WITH Outcome Number WITHOUT Outcome Total N (Denominator)

Control

Tx Arm 1

Tx Arm 2

Tx Arm 3

Tx Arm 4

2 x 2 Percent

Percent WITH Outcome Total N (Denominator)

Control

Tx Arm 1

Tx Arm 2

Tx Arm 3

Tx Arm 4

Page 24 of 26
------ ----- ----- -----

Comment about 2x2 Results

Submit This Section

Odds Ratio / Risk Ratio Data

If Results Presented in OR or RR format, Enter Here

There Are Separate Sections Below for UNADJUSTED and ADJUSTED OR/RR

-----

UNADJUSTED OR/RR

Metric ND gfedc

nmlkj OR (odd ratio) 

nmlkj RR (Risk Ratio/Relative Risk) 

nmlkj Other Which? 

Tx 1 vs Control: 

Tx 2 vs Control: 

Tx 3 vs Control: 

Tx 4 vs Control: 

----- ----- ----- -----

ADJUSTED OR/RR

Variables Adjusted For:

Metric ND gfedc

nmlkj OR (odd ratio) 

nmlkj RR (Risk Ratio/Relative Risk) 

nmlkj Other Which? 

Tx 1 vs Control: 

Tx 2 vs Control: 

Tx 3 vs Control: 

Tx 4 vs Control: 

Comment about OR/RR

Submit This Section

Statistical Significance

For 2x2 data, OR, RR, etc.

Page 25 of 26
p-value of UNADJUSTED Tx 1 vs Control ND gfedc

p-value of UNADJUSTED Tx 2 vs Control ND gfedc

p-value of UNADJUSTED Tx 3 vs Control ND gfedc

p-value of UNADJUSTED Tx 4 vs Control ND gfedc

p-value of ADJUSTED Tx vs Control ND gfedc

Comment about Statistical Significance

Submit This Section

Results TEMPLATE (Text)

Submit This Section

DUPLICATE THIS SECTION FOR EACH OUTCOME.

This will include both treatment and control arm

THERE SHOULD BE ONE NEW SECTION FOR EACH "OUTCOME."

Title each new Text Result section with "Outcome"

Description of Outcome (if 

necessary): 

Describe Results:

Submit This Section

Page 26 of 26
Appendix C. Evidence Tables 

EvidenceTable (Part 1)Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Adams2003 

Age (yr):65.1 (SD 7.9) Male%:85 Country: US Sites:2 BMI:29.1 Soy1 N:74 Soy2 N:76 Control N:0 

Design:RCT Randomized: Yes Blinding:double Duration:12 mo 

Undergoing colonoscopy, 50-80 y, adenomatouscolorectal polyps on currentor recent (within 12 mo)colonoscopyExcluded:HRT. Various GI and other medical conditions. Habitual soyfood intake >= 4servings/week. (Initiallyregualr NSAID use, lifted after 1 y enrollment to increase numbers.) 

1. ISP without isoflavone Soy drink powder packets(DuPont Protein Technologies, St Louis). 2packets/day = 58 g/d. Diet composition: 6240 kJ/d, carb 171 g/d, protein 61g/d, fat 59g/d 2. ISP with Isoflavone Soy drink powder packets(DuPont Protein Technologies, St Louis). 2packets/day = 58 g/d Diet composition: : 6500 kJ/d, carb 175 g/d, protein 64.7g/d, fat 62g/d

No non-soy control Insulin lik

factor (IGIGFBP-3 IGF-I/IGF

Adams2004 

Age (yr):63.9 (SD 7.2) Male%:100 Country: US Sites:1 BMI:29.1 Soy1 N:61 Soy2 N:51 Control N:0 

Design:RCT Randomized: Yes Blinding:double Duration:12 mo Duration:1 years

Subset of 

men from Soy

Isoflavone prevention trial Undergoing colonoscopy, 50-80 y, adenomatouscolorectal polyps on currentor recent (within 12 mo)colonoscopy and consented to PSA Excluded:HRT. Various GI and other medical conditions. Habitual highsoy food 

1. Soy drink powder packets (DuPont Protein Technologies, St Louis). 2packets/day = 58 g/d. ISP without isoflavone Diet composition: E 1528 kcal/d, Protein 61g/d, carb 170g/d, fat 37%2. Soy drink powder packets (DuPont Protein Technologies, St Louis). 2packets/day = 58 g/d ISP with IsoflavoneDiet composition: E 1545 kcal/d, protein 64g/d, carb 171 g/d, fat 36%E

No non-soy control PSA

Albert 2002 

Age (yr): >45 Male%: 0 Country: Spain Sites:13 

Design:NRNCT Randomized: No CohortSing 

post-menopausal, > 45 y, atleast one year a

menorrhea, 

at least 6 moderate or severe daily hot flushesprevious 15 day prior toinclusion 

Soy Isoflavones without protein Phytosoya soy preparation rich inisoflavones, capsulescontaining 17.5 mgisoflavones

No control Menopau

symptom hot flushesleep disovaginal dloss of libpsycholog

C-1
Appendix C. Evidence Tables 

C-2

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

BMI: Soy1 N: 190 Control N: 0 

Blinding:NoDuration:4 mo 

Excluded:HRT during previous 6 wks, R\loxifen tx, and personal records of breast cancer 

Diet composition:Detailed reporting of analyses of capsules

symptomBone pain 

Albertazzi1998 

Age (yr):53.3 (SD 0.45) Male%:0 Country: ItalySites:2 BMI:25.9 Soy1 N:51 Control N:53 

Design:RCT Randomized: Yes Blinding:double Duration:12 wks 

Postmenopausal women, atleast 6 mo since lastmenstrual period, or at least 6 wks since bilateral oophorectomy, at least 7 moderate or severe hot flushes, including night sweats per 24 hr during at least last 2 wks of 4-wkprestudy period, baseline FSH conc>50IU/L, srestradiol conc<35pg/mLExcluded:HRT < 6 wks prior prestudy period, meds for climacteric symptoms (vit E, clonidine, , and veralipride) 

soy 60 g of isolated soy protein in powder form, supplied bymanufacturer as identicallyappearing, code Supro ISP with IsoflavoneDiet composition: ND 

60 g of casein powder Protein40 g Product60 g Diet composition: ND 

Menopausymptom hot flushe

Albertazzi1999 

Age (yr):53.3 (SE 0.45) Male%: 0 Country: ItalySites:2 BMI:25.9 Soy1 N:51 Control N:53 

Design:RCT Randomized: Yes Blinding:double Duration:12 wks 

Postmenopausal women, atleast 6 mo since lastmenstrual period, or at least 6 wks since bilateral oophorectomy, 7 moderateor severe hot flushes, including night sweats per 24 hr during at least last 2 wks of 4-wk prestudyperiod, baseline FSH concentration > 50 IU/L & serum estradiolconcentration < 35 pg/mL 

soy Daily supplements of 60 gsoy powder Supro ISP with IsoflavoneDiet composition: ND 

60 g of casein contained 40 g ofproteins but no isoflavones.Total Protein 40 gTotal Product60 gDiet composition: ND 

Vaginal cmaturatioEquol 
Appendix C. Evidence Tables 

C-3

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Excluded: ND 

Alekel 2000 

Age (yr):50.2 Male%:0 Country: US Sites:1 BMI:24.0Soy1 N:24 Soy2 N:24 Control N:21 

Design:RCT Randomized: Yes Blinding:double Duration:24 wks 

Perimenopausl women with vasomotor symptoms; nonsmoking premenopausal >10 hot flashes/night sweats/wk,irregular menstrual periods. had1 or both ovaries, BMI between 20-31, willing to berandomized. FSH >30 IU/L Excluded:Chronic disease: osteoporosis or CVD, no long-term meds, no HRT or ERT within past 1

2 mo, no

excessive exercise

1. ISP with Isoflavone Jumbo muffins containing80.4 mg glycosidesDiet composition: ~2.09 MJ(500 kcal) and 650 mg Ca/d for the muffin 2. ISP with Isoflavone (low) Jumbo muffins containing4.4 mg glycosidescomponentsDiet composition: ~2.09 MJ(500 kcal) and 650 mg Ca/d from the muffin 

whey protein Total Protein: 40 g/dayTotal Product: NDDiet composition: ~2.09 MJ (500kcal) and 650 mg Ca/d 

Serum boalkaline phosphatType 1 Ccross-linkteleopeptUrinary caBMD BMC 

Anderson 1998 

Age (yr):64 (SD 6.5) Male%:100 Country: US Sites:1 BMI:35.1 Soy1 N:8 Control N:8 

Design:Xover Randomized: Yes Blinding:N

o

Duration:8 wks 

Men with insulin-treatedtype 2 D

M with fair

glycemic control defined asglycohemoglobin concentrations of < 8%. They were free of significant medical illnesses or uncontrolled conditions, substantial proteinuria (>1000 mg/d) or proteinuriaunrelated to DM or HTN Excluded:ND 

Soy diet Soy-protein diet, which provided 1 g protein/kg BW and were weightmaintaining.Diet composition:Standard diabetic exchange diet tomaintain body wt, carb ~55% E, fat 30%E

Animal-protein diet, which provided 1 g protein/kg BW and were weight maintaining. 50% of the protein in the form of ground beef and cow milkProduct:ND Diet composition: Standard diabeticexchange diet to maintain body wt, carb ~55% E, fat 30%E 

Total ChoLDL HDL TriglyceriglycohemGFR Sr creatinserum ure

Anderson 2002 

Age (yr):24.0 (SD 1.1) Male%:0 Country: US Sites:1 BMI:62.4 Total:38 

Design:RCT Randomized: Yes Blinding:double Duration:1 years

healthy women of anyethnic background 21-25Excluded:pregnancy/lactation, use of oralcontraceptive agents or steroid hormones,continuing longitudinal growth (height) 

isoflavone enriched soyprotein dietisoflavone-enriched soy protein isolate diet available in powder and as chocolate liquid.ISP with IsoflavoneDiet composition:ND 

soy protein isolates lacking isoflavonesProtein64.5 g at baseline Product Diet composition:ND 

Bone mindensityBone mincontent BMC-lum
Appendix C. Evidence Tables 

C-4

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Soy1 N:15 Control N:13 (soy and control completers only) 

Arjmandi 2003 

Age (yr):62.4 (SD 2.4) Male%:0 Country: US Sites:1 BMI:84.5 Total Enrol: 71 Soy1 N:20 Control N: 22(soy and control only forcompleters) 

Design:RCT Randomized: Yes Blinding:double Duration:3 mo 

postmenopausal women Excluded:GI disorders,cancer, DM, hypo or hyperthyroidism, liver or kidney problems, pelvicinflammatory disease, endometrial polyps, heavy smokers

soy protein 40 g daily soy supplement provided in 2 packs, eachcontaining 29 g powderedunflavored drink mix Soy diet Diet composition:protein 40g, carb 6 g, total fat 2g 

milk-based proteinProtein40 g Product Diet composition:protein 40g, carb 6g, total fat < 1g 

IGF-1 Serum boalkaline phosphatUrine deoxypyrUrinary caUrine PhoEstradiol

Ashton 2000 10694766 

Age (yr): 34-62 Male%:100 Country: Australia Sites:1 BMI:26.2 Soy1 N:45 Control N:meat diet--45 

Design:Xover Randomized: Yes Blinding:otherDuration: 4.3 wks 

healthy male vounteersaged 34-62 yr, no symptoms or prior dx of CHD Excluded: meds that affectlipids or BP, BMI>35 kg/m2, Total Cholesterol >7.5 mmol/L, Triglyceride >6.0mmol/L. 

Tofu diet 90-100% animal protein with 290g/tofu Diet composition:energy9.5 MJ; protein 16.9%E;carb 44%, total fat 32%, saturated fat 12.4%, MUFA 11.5%, PUFA 5.2%alcholo 5.4%, cholesterol 189.5 mg

Meat diet Total Protein: ND Total Product: NDDiet composition: subjectsconsumed 150g/d (raw weight) ofcooked lean red meat, all visible fatremoved + PUFA margarine 15g energy 9.6 MJ, protein 17.2%E, carb43.7%, total fat 32.4%, saturated fat 12.9%, MUFA 11.9%, PUFA 4.8%, alcohol 4.9%, cholesterol 253.2 mg 

Total ChoLDL HDL TriglyceriLDL:HDL 

Ashton 2000 

Age (yr):45.8 (SD 7.8) 

Design:Xover Randomized: Yes 

Healthy males Excluded:Symptoms or prior diagnosis of CHD. Use of any medication that 

Tofu diet Designed to replace 90-100% of animal protein with290 g tofu. 5 g butter, 5 g 

Lean meat diet: 150 g (raw weight) of cooked lean red meat, with all visible fat removed, each day. Total Protein: 32.4

Total ChoHDL TriglyceriLpa 
Appendix C. Evidence Tables 

C-5

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

11194529 Male%:100

Country: Australia Sites:1 BMI:26.2 Soy1 N:45 Control N:45 

Blinding:NoDuration:4.2 wks 

affects lipids or BP, BMI > 35, Total Cholesterol > 7.5 mmol/L, Triglyceride > 6.0 mmol/L. 

lard, 8 g olive oil Diet composition: E 9.5 MJ, 16.9%E protein, 44%E carb, 32%E fat, 12.4%E satfat, 11.5%E MUFA, 5.2%E PUFA, 189.5%E Cholesterol 

Total Product: 150 g raw meatDiet composition: E 9.6 MJ, 17.2%Eprotein, 43.7%E carb, 32.4%E fat, 12.9%E sat fat, 11.9%E MUFA, 4.8%E PUFA, 253.2%E Cholesterol

Free or NEsterified Acids Oxidized Factor VIFibrinoge

Azadbakht 2003 

Age (yr):62.5 (SD 12.1) Male%:71% Country: Iran Sites:1 BMI:70.6 Soy1 N:14 Control N:14 

Design:Xover Randomized: Yes Blinding:NoDuration:7 wks 

Type 2 DM patients who were free of any uncontrolled conditions orother renal disease. Allsubjects had proteinuriawith total urine proteinexcretion between 300 and 1000 mg/da, serum creatinine between 1 and2.5 mg/dl and blood ureanitrogen between 20 and 40 mg/dl Excluded:ND 

Soy protein diet 0.8 g/kg protein containing35% soy protein, 30%vegetable protein and 35%animal protein Soy diet Diet composition: E 2403 kcal/d, protein 54 g/d, fat 55 g/d, fiber 16.1g/d, SFA 6.8g/d, MUFA 10.2g/d,PUFA 14.2g/d 

Animal protein diet, 0.8 g/kg total protein, including 70% animal and 30% vegetable protein Protein56 Product Diet composition: E 2396 kcal/d,protein 55.6 g/d, fat 57.6 g/d, SFA 10.2 g/d, MUFA 8.8 g/d, PUFA 11.3g/d 

Total ChoLDL HDL TriglyceriLDL:HDL 

Baird 1995 

Age (yr): 45-65 Male%:0 Country: US Sites:4 BMI: ND Total enrol:97 Soy1 N:66 Control N:25 (soy and control for only completers) 

Design:RCT Randomized: Yes Blinding:NoDuration:4 wks 

postmenopausal, =< 65, => 2 yr after mensesExcluded:Antibiotics or HRT in past 6 mo, medsknown to affect outcomesmeasures

Soy dietsoy diet group ate dailyportions of soy foodsprovided by the study as a substitute for approximate Diet composition:ND 

Usual diet Control group instructed to eat asusual during dietary interventionperiod Protein:ND Product:ND Diet composition:ND 

Vaginal cmaturatioSex HormBinding GLH FSH Estradiol
Appendix C. Evidence Tables 

C-6

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Bakhit 1994 

Age (yr):43 (SD 12) Male%:100 Country: US Sites:1 BMI:27.1 Soy1 N:21 Soy2 N:21 Control1 N:21Control2 N:21

Design:Xover Randomized: Yes Duration:4 wks 

Males, Plasma Total Cholesterol > 5.7 mmol/L,able to eat samples of the study muffins. Excluded:Persons takinglipid altering medications, thryoid and liver disorders.

1. Isolated Soy Protein + Cellulose4 Muffins daily with (total) 25 g isolated soy protein, and 20 g celluloseSupro Diet composition:Supro 610 Isolated Soy Protein, Protein TechnologiesInternational, St. Louis, MO 2. Isolated Soy Protein + Soy Cotyledon Fiber 4 muffins daily with (total) 25 g Isolated Soy Protein and 20 g SoybeanCotyledon Fiber. Supro Diet composition:E:10692kJ, protein 19.7%KJ, carb 98%KJ, Fat 26.7 KJ

1. Casein + Soy Cotyledon Fiber 4 muffins daily with (total) 25 g Casein and 20 g Soybean CotyledonFiber. 2. 4 Muffins daily with (total) Casein25 g + cellulose 20 g celluloseProtein25 g Product Diet composition: 10225kJ, protein 19.2%KJ, carb 90.7%KJ, Fat 24.6 KJ 

Total ChoLDL HDL TriglyceriApo A1 Apo B/10VLDL 

Balk 2002 

Age (yr):56.8 (SD 5.9) Male%:Country: US Sites:1 BMI:ND Wt:154.5 lbs Soy1 N:13 Control N:14 

Design:RCT Randomized: Yes Blinding:double Duration:6 mo 

postmenopausal, omnivorous, intact uterusExcluded:H/o of tamoxifen use, endometrial cancer, soy allergy, HRT in past yr, current supplementation of isoflavones

Soy diet100 mg per day ofisoflavones via soy flour & corn cereal (Nutlettes byDixie). Soy & Placeb Diet composition:ND 

Placebo was wheat cereal, Grapenuts, that is low in isoflavonesbut similar in appearance & texture Protein:ND Product:ND Diet composition:ND 

Menopausymptom hot flushevaginal ddecreasedepressiourinary diAdditionaoutcomesheadachepalpitatiosweats, in

Baum 1998 

Age (yr):59.8 (SD 9.1) 

Design:RCT Randomized: 

Completion of menopause with >= 1 yr since the lastmenstrual period, plasma

1. ISP56 

ISP with IsoflavoneBasal diet + 40 g of soy

Casein and non fat dry milk(CNFDM, containing 0 mg total glycosides isoflavones/d; New 

Total ChoHDL Triglyceri
Appendix C. Evidence Tables 

C-7

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Male%:0 Country: US Sites:ND BMI:28.2 Soy1 N:23 Soy2 N:21 Control N:22 

Yes Blinding:double Duration:24 wks 

cholesterol concentration between 6.2 and 7.8 mmol/L. Excluded:HormoneReplacement Therapy, Anymedications known to lower lipids, h/o of DM mellitus or thyroid disease, or chronicillness, allergies to soybean protein. 

protein and 56 mg total glycosides isoflavones/day, Supro 675, Protein TechnoSupro  ISP90 

ISP with Isoflavone

Basal diet + 40 g of soyprotein and 90 mg total glycosides isoflavones/day, Diet composition:ND 

Zealand Milk Product) Protein40 g Product:ND Diet composition:ND 

Apo A1 Apo B/10Total choHDL2, HDNon-HDLLDL rece

Bazzoli2002 

Age (yr):21 (SD 1.8) Male%:0 Country: US Sites:1 BMI:22.4 Soy1 N:9 Control N:9 

Design:RCT Randomized: Yes Blinding:double Duration:4 wks 

female students modratelyactive from an exercise standpointExcluded:smoking, any soyproduct consumed>1 time/week, oral contraceptives

ISP w /isoflavonesSoy Isolated Soy protein w isoflavones consumed as a mixture w/ water and anapproved flavoringSupro Diet composition:ND 

whey protein Protein40 g Product:ND Diet composition:ND 

plasma lipperoxidesurinary 8- 2-deoxygTotal antistatus

Blum 2003 12595862 

Age (yr):55 (SD 5) Male%:0 Country: Israel Sites:1 BMI: Soy1 N:30 Control N:30 

Design:Xover Randomized: Yes Blinding:double Duration:6 wks 

Mildly hypercholesterolemic(LDL > 3.36 mmol/L), postmenopausal, women. (not aware of high cholesterol level). Excluded:HRT or vitaminsA, C, or E, or lipid-lowering Tx in preceding 2 mo 

soy supplement Diet packets with isolatedsoy protein withisoflavones. Fortified withvitamins and minerals, sugar ISP with IsoflavoneDiet composition:Unclear what food was allowed or replaced. 

Placebo of 25 g/day total milk protein in similar powder.Protein25 Product: ND Diet composition: ND: 

Total ChoLDL, HDLTriglyceriE-selectinICAM-1 IL 2R P-selectinVCAM-1 

Blum 2003 

Age (yr):55 (SD 5) 

Design:Xover Randomized: 

Mildly hypercholesterolemic(LDL > 3.36 mmol/L), postmenopausal, women. (not 

soy supplement Diet packets with isolatedsoy protein with

Placebo of 25 g/day total milk protein in similar powder.

Total ChoLDL HDL 
Appendix C. Evidence Tables 

C-8

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

12659466

Male%:0

Country: Israel Sites:1 BMI: Soy1 N:30 Control N:30 

Yes CohortMult Blinding:double Duration:6 wks 

aware of high cholesterol level). Excluded:HRT or vitaminsA, C, or E, or lipid-lowering Tx in preceding 2 mo. 

isoflavones. Fortified withvitamins and minerals, sugar ISP with IsoflavoneDiet composition:Unclear what food was allowed or replaced. 

Protein:25g Product: ND Diet composition: ND 

TriglyceriPeripheraendotheli

Bricarell

o

2004 

Age (yr):56 (SD 1) Male%:25 Country: BrazilSites:2 BMI:24.9 Soy1 N:60 Control N:60 

Design:Xover Randomized: Yes Blinding:double Duration:6 wks 

Recruited from dyslipidemiaclinics. 20-70 years, Total Cholesterol 200-350 

mg/dL, 

Triglyceride <400 mg/dL Excluded:Presence of CAD and other significant CVD, renal, hepatic,gastrointestinal, mental, and endocrine disorders,including DM and BMI >=30kg/m2. Hypolipidemic drugs in previous 8 wk

Soy milk1 L per day soy milk(flavored with vanilla) SoyMilkDiet composition: E 1580kcal, total fat34%

Unsat fat 39%, sat fat 

20%, carb 45%, protein 21

%, Cholesterol 113mg, 

fiber 16g 

1 L per day non-fat cow milknonfat mil1Protein:27.5 Product:1 L Diet composition: E 1578kcal, total fat 25%Unsat fat 24%, sat fat 20%,carb 53%, protein 21

%, Cholesterol 

142mg, fiber 13g 

Total ChoLDL HDL TriglyceriApo E Oxidized 

Brooks 2004 

Age (yr):54.1 (SD 0.6) Male%:0 Country: Canada Sites:ND BMI:27.1 Soy1 N:15 Control N1:15 Control N2:16 

Design:RCT Randomized: Yes Blinding:double Duration:16 wks 

healthy, postmenopausal, => 1yr of natural menopause Excluded:active bowel disease, malabsorption syndrome, exogenousestrogens within past 3 mo, phytoestrogen supplements within past 1 month, thyroid disorder, oral or parenteralcorticosteroids, antibioticuse in past 4 wks

Soy diet The study muffins for all 3 treatment groups containedsimilar ingredientsflour Diet composition: E 7326 kJ/d, protein 67.7g/d, fat 58g/d, carb 242.9.1g/d,fiber 18.3g/d 

1.Placebo muffin 2.Flaxseed muffinProtein7.5 Product:21g Diet composition: E 6933 kJ/d, protein 81.0g/d, fat 52.8g/d, carb240.2g/d, fiber 1

8.3g/d 

Urine deoxypyrBone spealkaline phosphatEstradiolEstrone Estrone SUrinary 2Urinary 1

Brown 2002 

Age (yr):27.6 (SD 0.12) 

Design:Xover Randomized: Yes 

Healthy premenopausal women with standard blood cell counts , and clinical 

Soy Supro ISP with IsoflavoneDiet composition: Standard 

2 control diet 1. PUFA diet 2.control diet protein 

Cortisol Menstrualength Sex Horm
Appendix C. Evidence Tables 

C-9

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Male%:0 Country: US Sites:1 BMI: Soy1 N:26 Control N:26 

Blinding:single Duration:11 mo 

chemistry determinationsExcluded:Oralcontraceptives < 6 mo, antibiotics < 3 mo, > 2 alcoholic drinks per day, irregular menstrual cycles, diets of high fiber(>25 g/day), high soy (>2 servings/wk), high fat (>35% kcal), or low fat (<25% kcal), vegetarianism, 

diet from 2,000-2,800 kcal/day. 37% kcal fat, 48%carb, 15%protein 

Protein: 15%EProduct:ND Diet composition: Standard diet from2,000-2,800 kcal/day. 37% kcal fat,48% carb, 15%protein

Binding GLH FSH EstradiolEstrone Estrone SProgesteProlactin TestosterAndrosteDHEA/DHUrinary 2Urinary 1

Bruce 2003 

Age (yr):68.9 (SD 1.03) Male%:Country: US Sites:1 BMI:20.5 Total enroll:42 Soy1 N:22 Control N:16 (soy and control for completers) 

Design:RCT Randomized: Yes Blinding:double Duration:6 mo 

Postmenopausal, > 60 yExcluded:HRT, breast cancer h/o, BMI > 35 

Isoflavones supplement Soy Isoflavones without protein Diet composition:ND 

Maltodextrin Protein Product3 Diet composition:ND 

T3 T4 TSH 

Burke 2001 

Age (yr):59.3 Male%:55.6 Country: Australia Sites:1? BMI:76.2 Soy1 N:10 

Design:RCT Randomized: Yes Blinding:NoDuration:8 wks 

Nonsmoking, men or women, at least 20 yearsold, currently on antihypertensive therapy for at least 6 mo with <=2 medications, SBP between 130 and 160 mm Hg, and alcohol intake <= 210 g alcohol/wk. Excluded:DM, renal disease (creatinine > 130 

1. HighSoyProteinHighFi 66 g soy protein/d, 12 g soluble Fiber in the form ofPsyllium husks Diet composition:E 8.1mJ/d, 23.7% E protein/day, 26.1%Efat,47.7%E carb. 2. HighSoyProteinLowFib 66 g soy Protein/dayDiet composition: E 

1.LowProteinHighFiber 15 g psyllium/day, 66 g maltodextrinpowder/day. Diet composition: E 9.3mJ/d, 12.2%E protein/day, 25.1%E fat,59.4%E carb. 2.Low, Protein, Low Fiber arm.66 g maltodextrin/day. Total Protein: 11.5% of energyTotal Product: 66 g maltodextrinDiet composition: E 9.0mJ/d, 11.5%

SBP DBP heart rate
Appendix C. Evidence Tables 

C-10

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Soy2 N:13 Control1 N:9 Control

2 N:9 

mmol/L), symptomatic heart disease, regular use of NSAIDs, psychiatric illness, B

MI > 33 kg/m2 for men 

and 37 kg/m2 for women 

10.0mJ/d, 22.

8% E 

protein/day, 26.5%Efat,49.9%E carb. 

E protein/day, 22.

8%E fat,62.2%E 

carb. 

Burke 2003 

Age (yr):50.8 (SD 0.1) Male%:0 Country: US Sites:1 BMI:27.1 Soy1 N:70 Soy2 N:65 Control N:76 

Design:RCT Randomized: Yes Blinding:double Duration:2 years

Perimenopausal women,45 - 55 y, at least 1 vasomotor symptom @ day; surgical menopause subjects okay if all other inclusion/exclusion met Excluded:HRT < 

3 mo, MI 

or stroke < 6 mo, h/o breast or endometrial cancer, invasive cancer < 

5 y, 

active thromboe

mbolic

disease, hormonal meds for osteoporosis-related fractures, low basln bone density, prev exposure to diethylstibestrol, dyslipidemia, or endometrial biopsy with hyperplasia 

1. High isoflavoneflavone 25 g ready-to-drink soy protein beverage ISP with IsoflavoneDiet composition:ND 2. Med isoflavone25 g ready-to-drink soy protein beverage ISP with IsoflavoneDiet composition:ND 

soy protein without isoflavones25 g ready-to-drink beverage Protein25 g Product:ND Diet composition:ND alcohol washed to removeisoflavones (<= 4 mg/day) 

Menopausymptom vasomotosymptom

Carroll 1978 

Age (yr):21 Male%:0 Country: Canada Sites:1 BMI:54.4 Soy1 N:10 Control N:10 

Design: Xover Randomized: Unclear Blinding:N

o

Duration:37 or41 (each arm different) days 

Healthy young women studying either food science or nutrition. Well nourished. Normal glucose, Triglyceride, T

otal 

Cholesterol, alkaline phosphatase, thyroxine, creatinine, calciu

m, sodiu

m, 

potassium, chloride, bicarbonate, hematologicaland urine analyses, and chest X-ray.Excluded:Obese, metabolicor other disease, received any medication known toaffect serum lipids or 

Soy diet All meals provided on a 5 day rotation. Meats were replaced by soy protein meat analogues (textured Soy diet Diet composition: E 1880kcal, protein 75g, carb 242g, fat 68g 

Mixed protein diet All 

meals provided

on a 5 day rotation. Regular foods to maintain weight and adequateamounts of essential nutrientsProtein:70Product: Diet composition: E 1853 kcal, protein 70g, carb 238g, fat 69g 

Total ChoTriglyceri
Appendix C. Evidence Tables 

C-11

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

ingested > 30 g/day ethanol in previous 4 mo. 

Cassidy1994 

Age (yr):24 Male%:0 Country: UK Sites:1 BMI:61.59Soy1 N:6 Control N:0 

Design:NRNCT Randomized: No CohortSing Blinding:N

o

Duration:1 month 

Healthy, nonvegetarianwomen, normal menstrualcycle, no meds => 6 moprior to record menses data Excluded:ND 

soy dietDuring 2nd month, startingon 1st day of menses, appropriate modificatioinswere 

made to the basal d 

ISP with IsoflavoneDiet composition:Energy8.5 with- 0.3 MJ, T

otal fat

60.0 with- 1.7g, Carb 260.3 with- 1.0g, Nonstarch polysaccharide 1

6.3 with0.7g, Starch 106.7 with2.7g, Nitrogen 2.10 with0.06 ug/g 

First complete menstrual cycleserved as control period, each Protein97.2 Product Diet composition:Energy 8.5 with0.1 MJ, Total fat 61.4 with- 0.7g, Carb 258.2 with- 1.9g, Nonstarch polysaccharide 1

6.0 with- 0.6g, 

Starch 108.3 with- 2.2g, Nitrogen 2.09 with- 0.03ug/g, Daidzein 0.76 with- 0.03 mg, Genistein 0.49 with0.03 mg 

Total Chobut N<1

0

Menstrualength Follicular Sex HormBinding GFSH EstradiolProgesteTestoster

Cassidy1995 7577895 study 1 

Age (yr):20-29 Male%:0 Country: US Sites:1 BMI:61.6 Soy1 N:6 Control N:0 

Design:NRCT Randomized: No CohortSing Blinding:N

o

Duration:1 mo 

non-vegetarian femalestudents, regular menstrual cycles and no medication for 6 mo before the study. Excluded:ND 

 45 mg conjugatedisoflavonesISP with IsoflavoneDiet composition:ND. 

No control Follicular 

length Luteal phTotal mencycle lengTotal ChoLDL HDL TriglyceriSex HormBinding GLH FSH ProgesteOestradioUrinary L

Cassidy1995 7577895 study3 

Age (yr): Male%:0 Country: US Sites:1 

Design:Xover Randomized: Yes Blinding:ND Duration:1 

non-vegetarian femalestudents, regular menstrual cycles and no medication for 6 mo before the study. Excluded: 

 isoflavones-free soyabean product ISP without isoflavone Diet composition:

8MJ/d 

Control diet Follicular 

length Luteal phTotal mencycle lengTotal ChoLDL 
Appendix C. Evidence Tables 

C-12

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

BMI: Soy1 N:5 Control N:5 

mo HDL 

TriglyceriSex HormBinding GLH FSH ProgesteOestradioUrinary L

Cassidy1995 7577895 Study 4 

Age (yr): Male%:0 Country: US Sites:1 BMI:57.0 Soy1 N:6 Control N:6 

Design:NRCT Randomized: No CohortSing Blinding:N

o

Duration:1 mo 

non-vegetarian femalestudents, regular menstrual cycles and no medication for 6 mo before the study. Excluded: 

half-dose conjugated isoflavones23 mg conjugated isoflavonesISP with IsoflavoneDiet composition:ND 

No control Follicular 

length Luteal phTotal mencycle lengTotal ChoLDL HDL TriglyceriSex HormBinding GLH FSH ProgesteOestradioUrinary L

Chen 2003 

Age (yr):54.4 (SD 3.1) Male%:0 Country: HongKong Sites:1 BMI:57.9 Soy1 N:68 Soy2 N:68 Control N:67 

Design:RCT Randomized: Yes Blinding:double Duration:1 years

age 48-62, postmenopausalwomen within 10 y of menopause Excluded:any meds known to affect bone or calcium metabolism, current use of or h/o of exogenousestrogens, corticosteroids,thiazine; soy allergic, anysystemic endocrine disease; any surgery known to affect bone health (Ovariectomy, thryoid gland or intestin 

1. high-dose soyisoflavones80 mg soy isoflavones, calcium 500 mg, Vitamin D 125 IU Soy Isoflavones without protein Diet composition:E 5.49MJ/d, protein 68.2g/d 2. mid-dose soy isoflavones40 mg soy isoflavones, 12.5 mmol calcium, 125 IU Vitamin D Soy Isoflavones without protein Diet composition: E 

corn starch + calciu

m 500

mg + 

Vitamin D 125 IU Protein:0 Product:0.5gDiet composition: E 5.44MJ/d,protein 74.6g/d 

Bone mindensityBone mincontent 
Appendix C. Evidence Tables 

C-13

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

5.38MJ/d, protein 71.3g/d 

Chen 2004 

Age (yr):54.4 (SD 3.1) Male%:0 Country: HongKong Sites:1 BMI:57.9 Soy1 N:68 Soy2 N:68 Control N:67 

Design:RCT Randomized: Yes Blinding:double Duration:1 years

age 48-62, postmenopausalwomen within 10 y of menopause Excluded:any meds known to affect bone or calcium metabolism, current use of or h/o of exogenousestrogens, corticosteroids,thiazine; soy allergic, anysystemic endocrine disease; any surgery known to affect bone health (Ovariectomy, thryoid gland or intestin 

1. high-dose soyisoflavones80 mg soy isoflavones, calcium 500 mg, Vitamin D 125 IU Soy Isoflavones without protein Diet composition: Diet composition:E 5.

49MJ/d, 

protein 68.2g/d 2. mid-dose soy isoflavones40 mg soy isoflavones, 12.5 mmol calcium, 125 IU Vitamin D Soy Isoflavones without protein Diet composition: Diet composition: E 5.38MJ/d,protein 71.3g/d 

corn starch + calciu

m 500

mg + 

Vitamin D 125 IU Protein:0 Product:0.5gDiet composition: Diet composition:E 5.49MJ/d, protein 68.2g/d 

Bone mindensityBone mincontent 

Chiechi  2002 11836040 

Age (yr):54.2 (SD 4.04) Male%:0 Country: ItalySites:1 BMI:68.5 Soy1 N:58 Soy2 N:53 Control N:55 

Design:RCT Randomized: Yes Blinding:N

o

Duration:6 mo 

All women in menopause as defined by 1)spontaneous menopause since at least 6 mo and withFSH >30 IU/L and E2 <20 pg/ml. 2) Bilateral ovariectomy.Excluded:age >60; drinking more than 14 standardalcoholic drinks weekly; hormonal replacementtherapy or cholesterol lowering drugs in the previous 6 mo; h/o cancer; adherence to a vegetarianor macrobiotic diet or to anyother medically prescribed diet; treatment for diabetes, presence of 

menopausal

Soy diet Diet intervention arm Women in the dietaryintervention group were asked to add a soy food serving every day (e.g. soy milk, Soy bean,T

ofu, 

SoyMilk) Diet composition:ND 

Usual diet ProteinND ProductND Diet composition:No data availableon the control arm

Total ChoLDL HDL TriglyceriApo A1 Apo B/10SBP DBP Total choApoA1:B Endometthickness Uterine aresistance 
Appendix C. Evidence Tables 

C-14

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

symptoms requiring therapy

Chiechi 2002 12191852 

Age (yr):54.2 (SD 4.04) Male%:0 Country: ItalySites:1 BMI:68.5 Soy1 N:58 Soy2 N:53 Control N:55 

Design:RCT Randomized: Yes Blinding:N

o

Duration:6 mo 

spontaneous menopause since 6 mo, FSH > 30 IU/I, E2 < 20 pg/ml, bilateral ovariectomyExcluded:age >60, drinking > 14 alcoholic drinks wkly, HRT or cholesterol loweringdrugs within 6 mo, h/o of cancer or other chronicdiseases, adherence to veg or macrobiotic diet, treatment for DM, presence of menopausal symptomsrequeiring therapy

soy dietwomen were invited to continue usual diet, onlyadding soy food servingevery day (soymilk, misosoup, tempeh, or soybeans) Diet composition:dailyconsumption of soy:22.25 g soybeans, 33.3 g tofu, 299.06 soymilk, 8.6 g tempeh, 2.4 g miso

Usual diet Protein:ND Product:ND Diet composition:"usual diet" 

Bone mindensityBone mincontent Serum OsType 1 Ccross-linkteleopeptFSH EstradiolHydroxyptinine 

Chiechi 2003 

Age (yr):54.2 (SD 4.04) Male%:0 Country: ItalySites:1 BMI:27.06Soy1 N:53 Control N:58 

Design:RCT Randomized: Yes Blinding:double Duration:6 mo 

Asymptomaticpostmenopausal women,39-60 y, incl spontaneousmenopause => 6 mo, FSH > 30 IU/1 and E

2 < 20 

pg/ml or with bilateral ovariectomyExcluded:>60 y, > 14 standard alcoholic drinksweekly, HRT, lipid-lowering, anti

osteoporotic or other 

interfering drugs < 6 mo, DM, H/o cancer, vegetarian or macrobiotic diet, menopausal symptomsrequiring tx

soy dietContinue usual diet & add soy food serving every day, to exchange 2 meals tice a week with mealsSoy diet Diet intervention arm Women in the dietaryintervention group were asked to add a soy food serving every day (e.g. soy milk, Soy bean,T

ofu, 

SoyMilk) Diet composition:ND 

Habitual diet of Southern ItalyProteinND ProductND Diet composition:No data availableon the control arm

FSH Estradiol: KaryopycMaturatio

Crisafulli2004 

Age (yr):52 (SD 0.5) Male%:Country: ItalySites:1 

Design:RCT Randomized: Yes Blinding:double Duration:1 

Healthy, ambulatorywomen, 47-57 yr, FSH > 50IU/L, serum E2 <= 100pmol/L, > 5 hot flushes @ dayExcluded:Sugical menopause, menstrual 

Genistein Phytoestrogen genistein, 54 mg/day, or HRT, or placebo. All pills identical inappearanceSoy Isoflavones without protein 

Placebo pills identical in appearance to intervention. ProteinND ProductND Diet composition:ND 

Endometthickness Menopausymptom Hot flusheestradiol 
Appendix C. Evidence Tables 

C-15

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

BMI:24 Soy1 N:30 Control N:30 

years period in preceding year, 

clinical or lab abnormalitiessuggesting CVD, hepatic, or renal disorders,coagulopathy, oral or transdermal estrogen,progestin, androgen orother steroids in precedingyear, >10 cigarettes/day

Diet composition:ND 

Crouse 1999 

Age (yr):52 Male%:60 Country: US Sites:1 BMI:26 Soy1 N:31 Soy2 N:31 Soy3 N:31 Soy4 N:31 Control N:31 

Design:RCT Randomized: Yes Blinding:otherDuration:9wks 

Mild cholesteremic (LDL 140-200 mg/dl) men and women after 1 month instruction in an N

CEP Step 

1 diet. Eligible individualshave to be 80% compliant with 25 g casein beveragerun in 1 month period.Excluded:current use of lipid lowering medications, H/o CVD, current H/o DM or blood glucose levelshigher than 6.94 mmol/L (125 mg/dl), uncorrected secondary causes of hypercholesterolemia,excessive alcohol consumption, triglyceride conc >4.52 mmol/L (>400 mg/dL), LDL cholesterol >5.17 mmol/L (>200 mg/dL), use of oralcontraceptives or estrogen replacement, and usual consumption of high soyprotein diet. 

1) Isolated soy proteinbeverage ISP with Isoflavone (62 mg) 2) Isolated soy proteinISP without isoflavone 3) Isolated soy proteinbeverage ISP with Isoflavone (27 mg) 4) Isolated soy proteinbeverage ISP with Isoflavone (37 mg) Diet composition: ND 

25 gram of caseinProtein25 gra

m

Product ND Diet composition: ND 

Total ChoLDL HDL TriglyceriLpa SBP DBP 

Cuevas2003 

Age (yr):59 Male%:0 Country: Chile 

Design:Xover Randomized: Yes Blinding:

Healthy, non-smoking, postmenopausal women hypercholesterolemia (LDL 4.14 and 6.21 mmol/l and triacylglycerol <3.39

Soy 40 gram of isolated soyprotein powder containing80 mg isoflavones (60%genistein, 30% daidzein, 10 

Caseinate powderProtein40 gra

m

Product:ND Diet composition: NCEP step 1 diet; <30%E fat, <10%E sat fat,

Total ChoLDL HDL TriglyceriSBP 
Appendix C. Evidence Tables 

C-16

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Sites:1 BMI:29.3 (0.81) Soy1 N:18 Control N:18 

double Duration:8 wks 

mmol/l). normal liver, kidney and thyroid functionsand normal fasting glucose concentrations. No patientsreceived vit, antioxidants, antilipemic agents, arginine, anti-HTN, soy foods Excluded:ND 

ISP with IsoflavoneDiet composition: NCEP step 1 diet; <30%E fat, <10%E sat fat, <300mg/daycholesterol 

<300mg/day cholesterol DBP 

Peripheraendotheliother testNitroglyceFSH 

Dalais1998 

Age (yr):54 Male%:0 Country: Australia Sites:0 BMI:26 Soy1 N:52 Control N:52 

Design:Xover Randomized: Yes Blinding:double Duration:12 wks 

45-65 yr; FSH>40 IU/ml, hot flush > 14 per wk; amenorrhea for 12 mos;no abx or HRT for preceding 3 mos., nonsmoker, non-vegetarian Excluded:ND 

Soy diet 45 grams per day of soygrits was achieved by using3 different types of bread with the same backgro soy bread Diet composition:ND 

45 grams/day of wheat kibble Protein without fatProtein:ND Product:45g/d Diet composition:ND 

Menopausymptom hot flusheVaginal cmaturatio

Dalais2003 

Age (yr):60 (SD 1) Male%:0 Country: Australia Sites:1 BMI:24.9Soy1 N:51 Control N:55 

Design:RCT Randomized: Yes Blinding:double Duration:3 mo 

Postmenopausal womenbetween 50 and 75 years,nonsmokers, nonvegetarians, not onHRT for the previous 12 mo, not consuming isoflavones or soy-based products and not on anyantibiotics for the previous3 mo. None of the studyparticipants were consExcluded:None 

Soy protein Soy protein, powder form(St Louis, MO, USA) ISP with IsoflavoneDiet composition: E 2228 kcal; protein 109g

Placebo Protein40 ProductND Diet composition: E 2211kcal; protein 112 g 

Urine deoxypyrUrine pyr

D'Amico Age (yr):41 Design:NRNC

T 

Patients with biopsy-proven glomerular disease. 

Vegtarian soy dietVegtarian soy diet, low in

No control Total Cho

LDL 
Appendix C. Evidence Tables 

C-17

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

1992 (SD 18)

Male%:

65% 

Country: ItalySites:1 BMI:22.7 Soy1 N:20 Control N:0 

Randomized: No CohortSing Blinding:N

o

Duration:8 wks 

Consistent proteinuria of > 1.5 g/24 h for a 

mean of 25 

mo (range 3-95]; serum creatinine < 220 u

mol/l; 

hyperlipidaemia (fasting serum cholesterol > 5.95mmol/l); no treatment with steroids or cExcluded:ND 

fat, moderately l

ow in 

protein, and rich in PUFA and MUFA and fiver Soy diet Diet composition: 11

% E

protein, 28% E fat, carb 46%

HDL TriglyceriApo A1 Apo B/10SBP DBP GFR 

Davis 2001 

Age (yr):25-40 Male%:100 Country: US Sites:1 BMI:ND Soy1 N:6 Control N:0 

Design:NRNCT Randomized: No CohortSing Duration:3 wks 

Healthy male e

mployees of 

Barbara Ann KarmanosCancer Institute No H/o of health proble

ms,

no medications, vitamins or hebal supplements taken Excluded:none reported 

Soy isoflavone mixture the tablets containgenistein, daidzein, and glycetin (1.3:1:0.3), which is estimated to contain 24%Diet composition:ND 

No control 5-OHmdU 

NF-kB 

Dent 2001 

Age (yr):50.2 (SD 3.6) Male%:0 Country: US Sites:1 BMI:24.1 Soy1 N:24 Soy2 N:24 Control N:21 

Design:RCT Randomized: Yes Blinding:double Duration:24 wks 

Perimenopausal women experiencing >=10 hot flashes and/or night sweatsper week, had irregular menses or cessation ofmenses for <1 yr, had one or both ovaries remaining, had a B

MI between 19-

31kg/m2 and were willing tobe randomizedExcluded:women with chronic disease (ie heart disease or osteoporosis), on medications chronically, sex hormone treatmentduring the past 1

2 mo, h/o

of an eating disorder or menstrual disorder and/or were excessive exercisers 

1. Isoflavone poor soyprotein isolate isoflavone poor soy protein isolate with 4.4 mg/d glycosides component  ISP without isoflavone Diet composition:ND. 2. Isoflavone +ve soyprotein SPI+ (80.4 mg/d glycosidescomponents) Name ISP with IsoflavoneDiet composition: ND 

Whey protein Total Protein: 40 gram/dayTotal Product: NDDiet composition: ND 

Total ChoLDL HDL TriglyceriLpa Factor VIFibrinogePlasminoactivator 
Appendix C. Evidence Tables 

C-18

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Dewell 2002 

Age (yr):69 (SD 1) Male%:0 US:1 Country: US Sites:1 BMI:25 (18-32) Soy1 N:20 Control N:16 

Design:RCT Randomized: Yes Blinding:double Duration:2 mo (HDL, nonHDL) , and 6mo (TotalCholesterol,Triglyceride) 

Healthy, moderatelyhypercholesterolemicpostmenopausal womennot receiving HRT.Excluded:Clinical or biochemical evidence of DM or renal, hepatic, or CV disease 

150 mg soy-derived isoflavones. Tablet. Sermipurified extract. Exclude soy-containingfoods from die Soy Isoflavones without protein Diet composition: E 6958 kJ, protein 17%, fat 34%,SFA 11% carb 48%

150 mg maltodextrin with 10%caramel color. Tablet. Exclude soycontaining foods from diet. Other control: Maltodextr Protein0 Product150 mg Diet composition: E 6460 kJ, protein15%, fat 34%, SFA 10% carb 50%

Non-HDL cholestermeasured CholesterTotal ChoHDL Triglyceri

Djuric 2001 

Age (yr):32 (SD 12) Male%:50 Country: US Sites:1 BMI:~80Soy1 N:6 Soy2 N:6 Control N:0 

Design:NRNCT2 Randomized: No CohortMult Duration:3 wks 

healthy male and female volunteers from KarmanosCancer Institute staff Excluded:none reported 

Soy extract pillssupplements contain equal amounts of genistein and daidzein and lesser amounts of glycitein(1:1:0.2 Soy Isoflavones without protein Diet composition: 

No control 5-OHmdU 

Duffy 2003 

Age (yr):58.8 (SD 1.1) Male%:0 UK:1 Country: Sites:1 BMI: Soy1 N:18 

Design:RCT Randomized: Yes Blinding:otherDuration:12 wks 

Postmenopausal womenaged 50-65. All subjectswere healthy and nonsmokers. Excluded:Use of HRT in the previous 12 mo, use of antibiotics in the previous 3 mo, current illness or use of psychoactive medication. 

Soy Isoflavones without protein Solgen Soya isoflavonesupplement Diet composition: E 7.8MJ,Fat 34.3%E, MUFA10.4%E, PUFA 5.2%E, SFA 12.7%E, Protein 15%E, carb 47.4%E 

lactose placebo Protein0 Product:2 capsules per dayDiet composition: E 7.0MJ, Fat31.9%E, MUFA 10.3%E, PUFA6.1%E, SFA 11.1%E, Protein 15%E,carb 45.3%E 

Tests of ffunctionEpisodic Sustained MenopausymptomSleepinesMood rati
Appendix C. Evidence Tables 

C-19

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Control N:18 

Duncan 1999 10522983 

Age (yr):56.9 (SD) 5.8 Male%:0 Country: US Sites:mutiple BMI:25.2Soy1 N:23 Soy2 N:23 Control N:23 

Design:Xover Randomized: Yes Blinding:single Duration: 13wks

Healthy postmenopausalwomen Excluded:strict vegetarian,high fiber, high soy, or low fat diets; regular vitamin and mineralsupplementation>Recommended DietaryAllowances; athleticism; cigarette smoking; antibioticor hormone use within sixmo; bleeding within 12 mo; hysterectomy or oopherectomy; FSH concentration of less than 25 IU/L; history of chronicdisorders, endocrine orgynecological diseases; benign breast disease; regular use of medication known to interfere with study endpoints (including aspirin); less than 90% or more than 120% ideal bodyweight; weight change >10 lb within the previous year, and inability to abstain fromalcololic beverages duingthe study. 

1. Soy protein powdersISP with Isoflavone (high) Diet composition: E 1783kcal, protein 114g, carb 233g, fat 48g, fiber 13g 2. Soy protein powders with ISP with Isoflavone (low) Diet composition: E 1755kcal, protein 114g, carb 232g, fat 45g, fiber 13g 

Soy protein powders with very low isoflavonesTotal Protein: ND Total Product: NDDiet composition: E 1799kcal, protein 111g, carb 242g, fat 46g, fiber 13g 

T3 T4 TBG TSH Cortisol Sex HormBinding GLH FSH EstradiolEstrone Estrone SProlactin TestosterAndrosteDHEA/DHInsulin 

Duncan Age (yr):26.5 Design:Xover

Randomized: 

Premenopausal women Excluded:vegetarian, high

1. Soy protein powdersISP with Isoflavone (high) 

Soy protein powders with very low isoflavones

T3 T4 
Appendix C. Evidence Tables 

C-20

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

1999 9920082 

(SD 4.7) Male%:0 Country: US Sites:1 BMI:23 Soy1 N:14 Soy2 N:14 Control N:14 

Yes Duration:3 mo 

fiber, high soy, or low fat diets; regular consumption of vitamin and mineral supplementation greaterthan the recommended dietary allowances; athleticism; cigarette smoking; antibiotic or hormone use within 6 mo; h/o of chronic dis ,endocrine or gynecological diseases; benign breast disease; regular use of medication known to interfere with studyendpoints (including aspirin); less than 90% or more than 120% ideal bodyweight; weight change >10 lb within the previous year, and inability to abstain fromalcololic beverages duingthe study. 

Diet composition: E 2221kcal, protein 116g, carb 293g, fat 67g, fiber 8.2g 2. Soy protein powders with ISP with Isoflavone (low) Diet composition: E 2272kcal, protein 113g, carb 296g, fat 74g, fiber 8.8g 

Total Protein: ND Total Product: NDDiet composition: E 2294kcal, protein 115g, carb 297g, fat 76g, fiber 8.7g

TBG TSH Insulin PRL Sex HormBinding GLH FSH EstradiolEstrone Estrone SProgesteTestosterAndrosteDHEA/DHcortisol

Faure 2002 

Age (yr):53.0 (SD 5.6) Male%:0 Country: France Sites:multipleBMI:24.9 Soy1 N:39 Control N:36 

Design:RCT Randomized: Yes Blinding:double Duration:14 wks 

Postmenopausal -natural or surgical, >= 6 mo since lastperiod, 7 or more moderateto severe hot flashes including nightsweats per 24 hr during 2 weekprestudy, FSH > 40 IU/L,E2 < 35 pg/mL Excluded:HRT < 6 wk, vitamin E, clonidine

isoflavonesPhytosoya is standarizedisoflavone supplementprepared from soy extract in 325 mg capsulePhytosoya Soy Isoflavones without protein Diet composition: 

Placebo capsule was formulated with similar appearance and state...capsule contained cellulosemicro celluloseProtein:ND Product:ND Diet composition:ND 

Menopausymptom hot flashehot flashenight sweSBP DBP 

File 2001 

Age (yr):27.1 (SD 3.2) 

Design:RCT Randomized: 

Student volunteers were reruited by circular email at King's College London. All 

1. high soya diet (100 mg total isoflavones/day)Soy diet 

No soy control tests of m

tests of frfunction
Appendix C. Evidence Tables 

C-21

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Male%:56 (based on thetotal sample) Country: UK Sites:1 BMI:ND Total:27 Soy1 N:~13-14 Soy2 N:~13-14 

Yes Blinding:N

o

Duration:10 wks 

subjects were healthy and medication free throughout the trial, and all were nonsmokers.Excluded:ND 

2. l

ow soya diet (0.5 mg

total isoflavones/day)Total Protein: 1

6% of total 

energyTotal

Product: ND 

Diet composition: The highsoya and low soy dietsprovided approximatelyequivalent a

mounts of 

energy (~1550 kcal/day) and equivalent proportionsof energy as fat (~37%),carb (~47%) and protein (~16%)

mood rati

Foth 2003 

Age (yr):56.21 (SD 5.01) Male%: 0 Country: GermanySites:1 BMI:>25Soy1 N:16 Control N:0 

Design:NRNCT Randomized: No CohortSing Blinding:N

o

Duration:24 wks 

Postmenopausal, FSH serum level > 40 mIU/ml or last period > 1

2 mo

Excluded:HRT < 

3 mo or 

prolactin metabolism meds, strict vegetarian, high-fiber, high-soy, low-fat diet, withphenylketonuria, BMI>25, tx for climateric disorders

Soy ISP with IsoflavoneSoy supplementation wasprovided as tastelesssoluble powder in dailydosage packets ingestedonce Diet composition:ND 

No control LH 

FSH EstradiolProlactin TestosterDHEA/DH

Gallagher 2004 

Age (yr):54.6 (SD 0.9) Male%:0 Country: US Sites:1 BMI:70.2Soy1 N:~22 Soy2 N:~24 

Design:RCT Randomized: Yes Blinding:double Duration:9 mo 

Postmenopausal womenbetween the ages of 40 and 62 years, with femoral neckdensity within the normal range (+- 2 SD) for theirage and Urine Ntelopeptidelopeptide excretion in the upper half of the normal, premenopausal range. Excluded:Severe chronicillness, primary

1. SPI 96 40 g soy protein isolate withisoflavones isolate with 96 mg/day isoflavonesISP with isoflavone Diet composition: 2. SPI 52 40 g soy protein isolate with52 mg/day isoflavonesISP with IsoflavoneDiet composition: ND 3. SPI 4 

No control Total Cho

LDL HDL TriglyceriApo A1 Apo B/10Bone mindensitySerum OsUrine N-te
Appendix C. Evidence Tables 

C-22

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Soy3 N or Control N::~19 

hyperparathyroidism or active renal stone disease, or on certain medications, such as bisphosphonates, anticonvulsants, estrogen,fluoride, or thiazidediuretics in the past 6 mo. 

40 g soy protein isolate without isoflavones ISP without isoflavone Diet composition 

Gardner 2001 

Age (yr):58.4 (SD 7.2) Male%:0 Country: US Sites:1 BMI:25.4 Soy1 N:34 Soy2 N:33 Control N:32 

Design:RCT Randomized: Yes Blinding:double Duration:12 wks 

Post-menopausal women,age < 80 years, B

MI 20-31

kg/m2. LDL 130-190 

mg/dL 

and Triglyceride <250 mg/dL. Excluded:S

mokers, taking 

HRT or lipid-lowering medication during previous3 mo, h/o CVD, D

M, breast 

CA, endometrial CA, ovarian CA in previous 1

0

years.

1. Soy+IsoflavoneSame as control except that protein = an isolated soy protein containg 80 mgglycosides isoflavones. ISP with IsoflavoneDiet composition:

287 Kcal 

(1200 kJ)2. Soy-Isoflavone Same as control, except protein = ethanol-extracted isolated soy protein withtrace a

mounts of isofl 

ISP without isoflavone Diet composition:

287 Kcal 

(1200 kJ), 40 g protein 

Milk protein supplement. Mixure of protein, carb, and calcium in a powder form. 42 g protein Protein42 g Product2 packetsDiet composition: 287 Kcal (1200kJ), 40 g protein 

Total ChoLDL HDL TriglyceriFSH EstradiolEstrone Androste

GardnerThorpe 2003 

Age (yr):35.6 (SD 11.2) Male%:100 Country: UK Sites:1 BMI:25.6 Soy1 N:20 Control N:20 

Design:Xover Randomized: Yes Blinding:double Duration:6 wks 

volunteers, omnivorous, healthy, non-smokers.Excluded:obese (bodymass index (BMI) > 30kg/m2) or had taken anyantibiotics or vita

min 

supple

ments within the 

previous month. 

Soy diet soy fl

our

soya scones the additional daily intake of isoflavones. Diet composition: E9238 kj, carb 223g, protein 71, total fat 74g, sat fat 24g, MUFA 26g, PUFA 1

0.8g 

wheat flour Protein Product3 wheat sconesDiet composition: E9600 kj, carb250g, protein 85, total fat 86g, sat fat31g, MUFA 30g, P

UFA 16.2g 

Total ChoLDL HDL TriglyceriOxidized markers ostress Sex HormBinding GTestosteroestradia

Gentile 1993 

Age (yr):45.4 (SD 4.5) Male%:

45% 

Design:NRNCT Randomized: No 

Patients with biopsy-proven glomerular disease. Proteinuria of > 2.5 g/24 h for a mean of 

24 mo (range 

3-90]; hyperlipidemia 

Veg soy diet Vegtarian soy diet, low infat, moderately l

ow in 

protein, and rich in PUFA and MUFA and fiver 

No control for the soy arm Total Cho

LDL HDL TriglyceriApo A1 
Appendix C. Evidence Tables 

C-23

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Country: ItalySites:1 BMI:22.1 Soy1 N:20 Control N:0 

CohortSing Blinding:N

o

Duration:2 mo 

(fasting serum cholesterol >250 mg/dl); no treatmentwith steroids or cytotoxic, non-steroidal antiinflammatory, or lipExcluded:ND 

Soy diet Diet composition: 11

% E

protein, 28% E fat, carb 46%

Apo B/10SBP DBP GFR Urinary P

Goldberg 1982 

Age (yr):44 Male%:58 Country: US Sites:1 BMI:103% IBW Soy1 N:12 Control N:12 

Design:Xover Randomized: Yes CohortMult Blinding:single Duration:6 wks 

Patients with pri

mary 

hypercholesterolemia. Total Cholesterol and L

DL > 95 

%ile after being on NIHtype IIA diet for 6 wks.Excluded:Hypertriglyceridemia, secondary cause for hyperlipidemia such as DM, thyroid disease, liver or renal dysfunction. Abnormalhematological or urine para

meters. Pregancy.

Estrogen containingmedication.

Soy_Diet 75% of protein Kcal (1

5%

of total Kcal) was derivedfrom soy protein.

25% from 

a variety of vegetable SoyMilkUnclear1 Diet composition: Calculated to keepsubjects' weights stable. E 2458 Kcal; Protein 19.

8%; 

carb 32.0%; Fat 43

75% of protein Kcal (1

5% of total 

Kcal) was derived from animal Dietcomposition:s and 25% from a variety of veOP fat1 Animal pro Protein20.4% of Kcal Product Diet composition:Calculated to keepsubjects' weights stable. 20%protein, 40% fat, 40% carb. 2460 Kcal; Protein 20.

4%; carb

32.2%; Fat 43.

2%; Sat fat 29.3 g; 

PUFA 49.2 g; PUF

A:SFA 1.71; 

Cholesterol 215 mg; Alcohol 4.1

%

Kcal 

Total ChoLDL HDL TriglyceriApo A1 Apo B/10Apo E VLDL, LDApo A-II, ratio. 

Habito2000 

Age (yr):45.7 (SD 7.6) Male%:100 Country: Australia Sites:1 BMI:26.2 Soy1 N:42 Control N:42 

Design:Xover Randomized: Yes Blinding:N

o

Duration:4 wks 

Healthy males, 35-62 yExcluded:Symptoms or previous diagnosis of prostate disease or other illness, alcohol intake >10%of total daily energy, longterm meds affecting sexhormone concentrations,training athletes, obesitywithBMI >35 kg/m2 

soy diettofu diet contained 290 g tofu/d (raw wt), containingabout 3 g soybean protein,Diet composition: E 9.5 MJ, Protein 1

6.9%E, Fat 

31.9%E, SF 12.4%E, MF11.5%E, PF 5.1%E 

Lean meat diet Total Protein: ND Total Product: 1

50g

Diet composition: E 9.6 MJ, Protein 17.2%E, Fat 32.

4%E, SF 12.

9%E, 

MF 11.8%E, PF 4.

8%E 

Sex HormBinding GEstradiolTestosterDihydroteAndrosteFree andindexEstradiolTestosteriol 

Ham 1993 

Age (yr):61 (SD 6.7) 

Design:Xover Randomized: Yes 

hypercholesterolemic men admitted to VA, 2 or morerisk factors for CHD. Willingness to reside and 

1. soy flour partially defatted extruded soy flour 6.5% fat Diet composition: E ND, 

2. nonfat dry milkDiet composition: E ND, protein 20%E, carb 55%E, Fat 25%E

T3 T4 TSH Total Cho
Appendix C. Evidence Tables 

C-24

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Male%:100 Country: US Sites:1 BMI:28 Soy1 N:17 Soy2 N:17 Control 1 N:17 Control 2 N:17N: 

Blinding:otherDuration:4 wks 

consume all meals at VA. Excluded:Those taking meds that altered lipidmetabolism, those who suffered from secondaryhypertriglyceride

mia, renal 

or hepatic disease.

protein 20%E, carb 55%E, Fat 25%E 2. soy protein isolate 50 g daily Supro 

610 

ISP without isoflavone Diet composition: E ND, protein 20%E, carb 55%E, Fat 25%E 3. ISP with cellul

ose 

20 g dietary fiber (cellul

ose) 

Diet composition: E ND, protein 20%E, carb 55%E, Fat 25%E 

LDL HDL Triglyceri

Han 2002 

Age (yr):48 (SD 1.1) Male%:0 Country: BrazilSites:1 BMI:25.6 Soy1 N:40 Control N:40 

Design:RCT Randomized: Yes Blinding:double Duration:4 mo 

women in menopause at least 1

2 mo, not on any

type of hormonal tx during previous 12 mo, not using lipid lowering drugs,antidiabetic meds, soybean derived products, or herbalsupple

ments. Intact utreus, 

FSH > 25 U/L, estradiol < 20 pg/ml, hot flashes.Excluded:h/o of uncontrolled HTN, stroke or TIA, dx of cancer within 5 y,MI 

1. isoflavones (insignificant amount of soy protein) 100 mg soy isoflavone capsules TID ISP with IsoflavoneDiet composition:ND 

2. insignificant a

mount of soy

without any kind of isoflavones (and glucose) TID ISP without isoflavone Diet composition: ND No control Protein Product Diet composition: NA 

Total ChoLDL HDL VLDL TriglyceriSBP DBP Glucose Endometthickness LH FSH EstradiolFBS MenopauKupperm(hot flash 

Hargreaves 2005 

Age (yr):32 (SD 8) Male%:0 Country: UK Sites:1 BMI:ND Soy1 N:28 

Design:RCT Randomized: Yes Blinding: NoneDuration:14 days 

Patients attending symptomatic breast clinics at University hospital anddue to undergo breast biopsy or definitive surgeryfor breast cancer Excluded: Menopausal, onchemotherapy, steroid or OCD therapy, noncompliant for soy treatment 

60g soy in the form of ground textured vegetable protein ISP with isoflavone 45mg Diet composition:ND 

Normal unsupplemented diet NA ApoD

TLI Ki67 ER labeliPR labeliApoptotic Mitotic indBcl-2 MO
Appendix C. Evidence Tables 

C-25

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Control N:23 Control N2:33 

Hermansen 2001 

Age (yr):63.6 (SD 7.5) Male%:70% Country: NorwaySites:1 BMI:30 Soy1 N:20 Control N:20 

Design:Xover Randomized: Yes Blinding:double Duration:6 wks 

Healthy Type 2 diabeticswith normal liver and renalfunctionExcluded:Insulin, hypolipidemic agents, BBs, aspirin 

soy ISP 50 g/d + 20 g soycotyledon fiber (Supro) ISP with IsoflavoneDiet composition:totalenergy 2040 kcal/d, carb 47E, fat 30% enregy,protein 19%, alcohol 4%, fiber 26%, cholesterol 290mg/d 

50 g casein + 

20 g cellulose

Total Protein: ND Total Product: NDDiet composition: total energy 2021kcal/d, carb 48E, fat 30% enregy,protein 19%, alcohol 4%, fiber 27%,cholesterol 327 

mg/d 

Total ChoLDL HDL TriglyceriLpa Apo B/10SBP DBP HomocysFactor VIFibrinogevon WilleFactor, FaVIII:Ag PAI-1 HgbA1cFBS 

Hill 2004 

Age (yr):21.8 (SD 2.0) Male%:100 Country: US Sites:1 BMI:25.3 Soy1 N:9 Control N:9 

Design:RCT Randomized: Yes Blinding:double Duration:4 wks 

"recreationally trained young adult men";active life style incorporating resistance training for 6 mo Excluded:smoking, soyconsumption > 1/wk, competitive lifters and athletes

ISP Supro ISP with IsoflavoneDiet composition:soyprotein daily service contained 88 mg naturallyoccurring isoflavones(glycosidesweight)/53 mg genistein,OR 151 mg total isoflavones(conjugated weight)/90 mg genistien 

anti

oxidant poor whey protein 

Protein39 g Product:ND Diet composition:ND 

Oxidized IL-8 

Hsu 2001 

Age (yr):51.4 (SD 4.3) Male%:0 Country: Taiwan Sites:1 

Design:NRNCT Randomized: No CohortSing Blinding:N

o

healthy postmenopausalwomen Excluded:no meds for 6 mobefore study

isoflavone isoflavone supplementsSoy Isoflavones without protein Diet composition: 

No control Total Cho

LDL HDL HDL/LDL TriglyceriBone mindensityEstradiol
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

BMI:ND Weight:53.0 Soy1 N:37 Control N:0 

Duration:6 mo 

Huff 1984 

Age (yr):49 (SD 5) Male%:100 Country: Canada Sites:1 BMI:82 Soy1 N:5 Control N:5 

Design:Xover Randomized: Yes Blinding:double Duration:6 wks 

5 male outpatientswithfasting cholesterol exceeding normal, LDL >190 mg/dl, fasting Triglyceride <200 Excluded: ND 

soybean dietwhole soybean protein diet,all-plant protein in which meat and dairy protein wasreplaced by soybeaSoy bean Diet composition:protein 81g/d, carb 291g/d, fat 99 g/d, cholesterol 173 mg/day

high polyunsaturated fat, low cholesterol diet containing mixed protein from meat, dairy, plant sour Other control: variousProtein41 g Product Diet composition:protein 82 g/d, carb287g/d, fat 95 g/d, cholesterol 133mg/day

VLDL IDL LDL HDL Total ChoTriglyceriFBS 

Jayagopal 2002 

Age (yr):62.5 (SD 6.77) Male%:0 Country: UK Sites:1 BMI:32.2 Soy1 N:33 Control N:33 

Design:Xover Randomized: Yes Blinding:double Duration:12 wks 

Postmenopausal womenwith type 2 DM Excluded:Any secondarycause of hyperglycemia,current or previous (in the preceding 6 mo) use of estrogen therapy, treatmentwith insulin or oralhypoglycemic agents, untreated hypothyroidism, h/o of drug or alcohol abuse, and h/o of breast oruterine cancer 

Soy isolated soy protein withisoflavones (Essential Nutrition, Brough, U.K.). The product was completel ISP with IsoflavoneDiet composition: ND 

Placebo Protein:ND Product:ND Diet composition:No significantcalorific content 

Total ChoLDL HDL TriglyceriSBP DBP HgbA1cFBS Insulin semeasure Sr creatinT3 T4 TSH Sex HormBinding GLH FSH TestosterAndrosteDHEA/DHcatradiol 

C-26
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Jenkins1999 

Age (yr):56.5 (SD 9.0) Male%:61 Country: Canada Sites:1 BMI:24.6 Soy1 N:31 Control N:31 

Design: Xover Randomized: Yes Blinding:otherDuration: 4.2 wks 

19 hyperlipidemic men, 12postmenopausal women--all with LDL >4.1 mmol/L,Triglyceride <4.

0. 

Excluded: withclinical or biochem evidence of DM or liver or renal disease, on hypolipidemic agents

Soy-containing diet93% animal protein replaced with vegetable protein from soyDiet composition:energy2341 kcal/d;total protein 118 g/d 20.2%; 110 g/d vegetable protein 18.8%; carb 318 g/d 54.

3%;total fat 

66 

25.5%;SFA 16 g/d 

6%;MUFA 22 g/d 8.4%;PUFA 25 g/d 9.6%; dietarychol 77 mg/d 33%, alcohol 0 

lacto-ovo vegetarian diet Total Protein: ND Total Product: NDDiet composition: Energy 2519kcal/d; total protein 121 g/d 19.2%;27 g 4.

3%;carb 343 

54/6%;total fat 71 25.5%; SFA 18g/d 6.5%, MUFA 24 8.

4%, PUFA 24

g/d 8.7% cholesterol 76 30.2%alcohol 0 

Total ChoLDL HDL TriglyceriLpa Apo A1 Apo B/10SBP DBP Oxidized Thiobarbireactive sTotal:HDL cholesterLDL:HDL cholesterApo B:A-

Jenkins2000 10647066 

Age (yr):56 (SD 2) Male%:75 Country: Canada Sites:1 BMI:24.2 Soy1 N:20 Control N:20 

Design:Xover Randomized: Yes Blinding:N

o

Duration:8wks 

Hyperlipidemia (LDL > 4.1mmol/L, Triglyceride < 4.0 mmol/L), Inclusion in prior study. Excluded:Clinical or biochemical evidence of DM or liver or kidney disease. 

Vegetable protein foodsderived from soy, legumes,cereal foods, Diet composition:1795 Kcal; Protein 83 g/day, 18.5%; carb 254 g/d, 57.3%; Fiber, total 38 g/d;Fiber, soluble 11 g/d (sig higher); Fat 49 g/d, 23.

6%;

SFA 11 g/d, 5.

5%; MUFA 

18 g/d, 8.7%; PUF

A 16 g/d,

7.7%; Cholesterol 74 mg/d(NS); EtOH 2 g/d, 0.7%

Low-fat, low-cholesterol milk and egg products, soups, and low-fat, low soluble fiber dishes (Lean Cuisine and Weight Watchers). Total Protein: 89Total Product: NDDiet composition: 1 g/day of soyprotein 1901Kcal; Protein 89 g/day, 18.7%;carb 270 g/d, 57.

2%; Fiber, total 30 

g/d; Fiber, soluble 7 g/d (sig lower); Fat 49 g/d, 23.1%; SFA 14 g/d, 6.9%; MUFA 17 g/d, 8.1%; PUFA 1

3

g/d, 6.0%; Cholesterol 104

mg/d 

(NS); EtOH 2 g/d, 0.7%

Total ChoLDL HDL TriglyceriApo A1 Apo B/10Oxidized Total:HDL LDL:HDL Apo B:Ap

Jenkins200010778882 

Age (yr):56.5 (SD 9.0) Male%:61 Country: Canada Sites:1 

Design: Xover Randomized: Yes Blinding:otherDuration: 4.2 wks 

19 hyperlipidemic men, 12postmenopausal women--all with LDL >4.1 mmol/L,Triglyceride <4.

0. 

Excluded: withclinical or biochem evidence of DM or liver or renal disease, on hypolipidemic agents

Soy-containing diet93% animal protein replaced with vegetable protein from soyDiet composition:energy2341 kcal/d;total protein 118 g/d 20.2%; 110 g/d vegetable protein 18.8%; 

lacto-ovo vegetarian diet Total Protein: ND Total Product: NDDiet composition: Energy 2519kcal/d; total protein 121 g/d 19.2%;27 g 4.

3%;carb 343 

54/6%;total fat 71 25.5%; SFA 18g/d 6.5%, MUFA 24 8.

4%, PUFA 24

Oxidized 

C-27
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

BMI:24.6 Soy1 N:31 Control N:31 

carb 318 g/d 54.

3%;total fat 

66 

25.5%;SFA 16 g/d 

6%;MUFA 22 g/d 8.4%;PUFA 25 g/d 9.6%; dietarychol 77 mg/d 33%, alcohol 0 Isoflavones: no data:

g/d 8.7% cholesterol 76 30.2%alcohol 0 

Jenkins2002 12077742 

Age (yr):62 (SD 2) Male%:56 Country: Canada Sites:1 BMI:25.3 Soy1 N:55 Soy2 N:55 Control N:55 

Design:Xover Randomized: Yes Blinding:N

o

Duration:1 mo 

Healthy hyperlipidemicmen, postmenopausal women Excluded:ND 

1.High isoflavone group 2. L

ow isoflavone group 

Self-selected National Cholesterol EducationProgra

m step 2 diets

Soy diet:Tofu, low fat soyMilk, soy hotdogs,breakfast links, soyburgers, cold cuts and tofunuggets Diet composition: 2000kcal diet; 92%E protein, 59%Ecarb, 18%E fat, SFA 4%E,MUFA 13-15%E, PUFA 6.4-6.9%E 

Low fat dairy food replaced protein inNCEP step 2 diet Protein:88g Product:ND Diet composition: 2000kcal diet; 88%E protein, 60%E carb, 16%E fat, SFA 7%E, MUFA 12%E, PUFA 5.9%E 

C-reactive IL 6 seru

m am

Tu

mor ne

factor-α

Jenkins2002 12145008 

Age (yr):62 (SD 2) Male%:56 Country: Canada Sites:1 BMI:25.3 Soy1 N:55 Soy2 N:55 Control N:55 

Design:Xover Randomized: Yes Blinding:N

o

Duration:1 month 

Hyperlipidemic men, postmenopausal women Excluded:ND 

1.High isoflavone group 2. L

ow isoflavone group 

Self-selected National Cholesterol EducationProgra

m step 2 diets

Soy diet:Tofu, low fat soyMilk, soy hotdogs,breakfast links, soyburgers, cold cuts and tofunuggets Diet composition: 2000kcal diet; 92%E protein, 59%Ecarb, 18%E fat, SFA 4%E,MUFA 13-15%E, PUFA 6.4-6.9%E 

Low fat dairy food replaced protein inNCEP step 2 diet Protein:88g Product:ND Diet composition: 2000kcal diet; 88%E protein, 60%E carb, 16%E fat, SFA 7%E, MUFA 12%E, PUFA 5.9%E 

Total ChoLDL HDL TriglyceriLpa Apo A1 Apo B/10SBP DBP HomocysIL 6 Total:HDL cholesterLDL:HDL cholesterApo B:A-Oxidized Coronary disease r

C-28
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Jenkins2003 EMB2003048927 

Age (yr):57 (SD 2) Male%:100 Country: Canada Sites:1 BMI:25.3 Soy1 N:46 Control N:46 

Design:Xover Randomized: Yes Blinding:ND Duration:3-12 wks 

Men participated in 1 or more of 4 studies designed to assess the effect of soy protein on blood lipids. They were selected either by news paper ads or from patients already attending the Clin Nutr and RF Modific Clinics (increased LDL>4.1 mmol/L). None had clinical or biochemical evidence of DM, liver or renal disease Excluded:ND 

1. ISP w/isoflavone

(116mg) 

2. ISP w/isoflavone

(166mg) 

3. ISP w/isoflavone

(82 mg) 

Diet composition: E 2208, protein 111g/d, carb 300g/d,total fat 57g/d, cholesterol 113mg/d 

Study 1: low fat diary foods, egg substitutes, additional soluble fiber; Study 2:starch based cereal low fat diet Protein106 Product:ND Diet composition: E 2276, protein106g/d, carb 315g/d,total fat 58g/d,cholesterol 108mg/d 

PSA 

Jones2003 

Age (yr):16.7 (SD 0.78) Male%:100 Country: Australia Sites:1 BMI:73.4 Soy1 N:69 Control N:59 

Design:RCT Randomized: Yes Blinding:double Duration:6 wks 

Male students aged 16-18 years old Excluded:ND 

Isoflavones Novasoy Diet composition:ND 

Placebo tabletProtein:ND Product:ND Diet composition:ND 

Serum boalkaline phosphatUrine pyrPyridinolicreatinine 

Kanazawa 1995 

Age (yr):54.2 (SD 13) Male%:53 Country: Japan Sites:1 BMI:ND Soy1 N:15 Control1N:10

Design:NRCT Randomized: No CohortMult Blinding:NoDuration:6 mo 

outpatients who did not use hypolipemic agents--healthy patients and those with CVD identified byclinical sumptoms, carotidangiography, CT. Excluded:as above 

soycremeextract of soybeanscontaining 62% water, 10.6% protein, 8.2% lipid,16.8% carb Diet composition:ND 

no soycreme ProteinND Product0 Diet composition:ND 

Oxidized 

C-29
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Control

2 N:11

Katsuyama 2004 

Age (yr):30.4 (SD 9.8) Male%:0 Country: Japan Sites:1 BMI:22.1 Soy1 N:21 Soy2 N:16 Soy3 N:18 Control N:18 

Design:RCT Randomized: Yes Blinding:N

o

Duration:12 mo 

Healthy female hospital workers. Excluded:Dropping out, menopause, pregnancy,CVD, oopherectomy, anticoagulant use, protocol neglect. 

 Natto: soybeansfermented by Bacillus natto, a traditional Japanese food.30 g natto at lunchtime I 1. One/mo Diet composition:E 1787 kcal/d, protein 63.2g/d 2. Served 1/week at lunch Diet composition:E 1740 kcal/d, protein 59.3g/d 3. 3/wkDiet composition:E 1799 kcal/d, protein 69.4g/d 

Regular diet. No natto intakeProtein Product Diet composition: Diet composition:E 1736 kcal/d, protein 62.7g/d 

Serum boalkaline phosphatSerum OsType 1 Ccross-linkteleopeptUrinary caStiffness 

Khalil2002 

Age (yr):58.8 (SD 2.5) Male%:100 Country: US Sites:1 BMI:ND Soy1 N:32 Control N:32 

Design:RCT Randomized: Yes CohortMult Blinding:double Duration:3 mo 

Men with no known h/o ofosteoporosis, cancer, insulin-dependent DM, liver and kidney diseases, thyroid and parathyroid disorders, chronic GI disorders or allergy to milkor soy protein Excluded:Current use of any prescriptionmedications known to alter bone and calcium metabolism 

Soy protein isolateISP with IsoflavoneDiet composition:ND 

Milk-based protein (MP) Protein40 Product58 Diet composition:ND 

IGF-1 Serum boalkaline phosphatU-pyr 

Knight 2001 

Age (yr):52.3 (SD 3.7) Male%: 0 Country: Australia Sites:2 BMI:69.9 

Design:RCT Randomized: Yes Blinding:double Duration:12 wks 

Postmenopausal,symptomatic with > 3 flushes @ dayExcluded:HRT < 

6 wks, h/o 

active bowel, liver, gallbladder disease; tx for DM, malignancy, vegetarians, regular soy-product users

Soy Isoflavones without protein The isoflavone powder, TakeCare, was packaged in sachets to be used daily. Diet composition: 

The placebo was an isocaloriccasein-based beverage used dailyProteinND Product 60g Diet composition:ND 

Green mescore: Menopausymptom Flushing Vaginal mindexSex HormBinding GFSH 

C-30
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Soy1 N:12 Control N:12 

TBG Alkaline phosphatPyridinium linksGamma l

Kotsopoul

o

s 2000 

Age (yr):59 (SD 1) Male%:0 Country: Australia Sites: BMI:25 Soy1 N:44 Control N:50 

Design:RCT Randomized: Yes Blinding:double Duration:3 mo 

Postmenopausal, 50-7

5 yr

Excluded:S

moker,

vegetarian, HRT past 12 mo, ingesting phytoestrogens or soybased products, antibioticspast 3 mo 

soy Soy dietary supplementsupplied in powder form in sachets, ingested twice daily ISP with Isoflavone Diet composition:ND 

Identically presented placebo (casein) supplied in powder form in sachets ProteinND Producttwice dailyDiet composition:ND 

Menopausymptom flushesvaginal dVarious psychologoutcomes hair, skin Musculosoutcomes muscle pabackachegenitourinoutcomes dyspareu

KreijkampKaspers2004 

Age (yr):66.5 4.7 Male%:0 Country: NetherlandSites:1 BMI:26.4Soy1 N:100 Control N:102 

Design:RCT Randomized: Yes Blinding:double Duration:12 mo 

Women aged 60 to 75years identified via the database of a breast cancer screening program Excluded:Active liver disease, impaired renalfunction, h/o of breastcancer or other malignancy,h/o of thromboembolism or deep venous thrombosis, endometrial thickness of more than 4 mm, estrogen users within past 6 mo, and known allergy or hypersensensitivity to cow or soy milk

SP isoflavone-ruch S

oy protein 

ISP with IsoflavoneDiet composition: E 1887kcal, 82.5g protein, 69.5 g fat, 28.8 g sat fat, 25.1 g MUFA, 1

5.5 g 

PUFA, 213g carb 

Milk protein powder Protein25.6 Product36.5 Diet composition: E 1862kcal, 81.3g protein, 71.91 g fat, 31.8 g sat fat, 26.2 g MUFA, 1

3.5 g PUFA, 206 g

carb

Total ChoLDL HDL TriglyceriLpa Bone mindensitySerum boalkaline phosphatPlasma cCognitivelong-term and visuatests 

C-31
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

KreijkampKaspers2005 

Age (yr):66.5 4.7 Male%:0 Country: NetherlandSites:1 BMI:26.4Soy1 N:100 Control N:102 

Design:RCT Randomized: Yes Blinding:double Duration:12 mo 

Women aged 60 to 75years identified via the database of a breast cancer screening program Excluded:Active liver disease, impaired renalfunction, h/o of breastcancer or other malignancy,h/o of thromboembolism or deep venous thrombosis, endometrial thickness of more than 4 mm, estrogen users within past 6 mo, and known allergy or hypersensensitivity to cow or soy milk

SP isoflavone-ruch Soy protein ISP with IsoflavoneDiet composition: E 1887kcal, 82.5g protein, 69.5 g fat, 28.8 g sat fat, 25.1 g MUFA, 15.5 g PUFA, 213g carb 

Milk protein powder Protein25.6 Product36.5 Diet composition: E 1862kcal, 81.3g protein, 71.91 g fat, 31.8 g sat fat, 26.2 g MUFA, 13.5 g PUFA, 206 gcarb

SBP DBP Endotheli

KritzSilverstein 2003 

Age (yr):61 (SD 5) Male%:0 US:1 Country: Sites:1 BMI:ND Soy1 N:28 Control N:28 

Design:RCT Randomized: Yes Blinding:double Duration:6 mo 

Women who were in goodhealth, postmenopausal for at least 2 years, and werenot using ERT Excluded:ND 

Soy isoflavonesSoy-extracted isoflavone (Healthy Woman: SoyMenopause Supplement, Personal ProductsCompany, McNeilSoy Isoflavones without protein Diet composition:ND 

Placebo pillsidentical-appearing pills that contained inert ingredients (<1mg isoflavones per day)ProteinND Product2 pillsDiet composition:ND 

Cognitve 

Kumar Age (yr):41.3 Design:RCT

Randomized: 

healthy, pre-menopausal, omnivorous (including

Soy protein supplement Soy protein supplement

isocaloric placebo supplement of identical appearance w/ Tx using 

Menstrualength 

C-32
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

2002 (SD 1.03)

Male%:0 Country: US Sites:1 BMI:24.2 Total:97 Soy1 N:33 Control N:33 (Soy and control completers) 

Yes Blinding:double Duration:12 wks 

nonvegan vegeterians) of all races and ethnicities, between the ages 25-55 yat first screening, admitted consecutivelyExcluded:H/o of any type ofcancer, prgnancy or breastfeeding within 12 mo preceding the study; current use of hormones including birth control pills or HRT; peri

menopausal status; 

irregular menstrual cycles; body mass index>38; antibiotic use within a 3 moperiod and vegans

containing 40 mg of genistein (20 mg per dose) Diet composition:E 1967kcal, protein 110gm, fat 63.8 g

m, carb 228.9gm, 

chol 221mg 

milk protein ProteinND ProductND Diet composition:E 1810kcal, protein 97.2gm, fat 56.1 gm, carb 220gm, chol 1

88mg 

follicular Sex HormBinding GEstradiolEstrone anthropommeasurem(height, wfold, circu

Kurowska1997 

Age (yr):55 (SD 11) Male%:50 Country: UK Sites:3 BMI:80 Soy1 N:34 Soy2 N:34 Control N:34 

Design:Xover Randomized: Yes Blinding:otherDuration:3 X 4 wks 

healthy volunteers with hypercholesterolemia= total cholesterol 5.8-5.9 mmol/L, LDL 3.5-5.4 mmol/L. Initial Triglyceride 0.

8-3.7

mmol/L, habitual milkdrinkers (>2 glasses/d)Excluded:thyroid disroders,kidney diseases, DM, alcohol intake >

2 drinks/d, 

cholesterol lowering meds

1. soybean diet 3 cups soybean milk/d, 1/2 cup soybean dessert/d  Soy diet 16 g soybe Diet composition:1996 kcal energy; protein 1

9% total 

energy, 96 g protein, carb51

% total energy, fat 

29%

total energy, 17.8 g SFA, 16.7 g PUFA, 22.4 g MUFA 

3 cups 2% cows' milk/d (each containing 3.6% protein) + 1/2 cup l

ow-fat milk dessert/d 

(containing nonfat milkProtein31 g Product Diet composition:

2014 kcal energy; 

protein 19% total energy, 98 g protein, carb 51% total energy, fat 29% total energy, 24.7 g SFA(p<0.0001) , 9.2 g PUFA, 23.6 gMUFA 

Total ChoLDL HDL TriglyceriApo A1 Apo B/10SBP DBP Oxidized 

Laskowski2003 

Age (yr):16.24 Male%:ND Country: Poland Sites:1 BMI:64.9 Soy1 N:6 

Design:NRCT Randomized: Unclear Blinding:N

o

Duration:4 wks 

Young healthy judo athleteswho won medals inNational Champi

onships.

Excluded: ND 

soy protein supplement 0.5 g/Kg/day of soy protein supple

ment 

Diet composition: E 4000 kcal/day, protein 100g/d, fat 170g/d, carb 510g/d 

no soy protein supplementProtein:0 Product:same amount as soysupple

ment as liquid orange juice 

Diet composition: same as soy arm 

Max OxygVO 2 max

Total WoPeak PowTotal Womeasured Wingate t

C-33
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Control N:6 

Lenn 2002 

Age (yr):23.4 Male%:59 Country: US Sites:1 BMI:23.9 Soy1 N:7 Soy2 N:8 Control N:7 

Design:RCT Randomized: Yes Blinding:ND Duration:5 wks 

men and women from University of Kentucky Excluded:h/o of significant pain/fx in arms or shoulderswithin past 3 years;strength training within 60days before study;applicances in arms or shoulders; pacemaker; pregnancy; acute trauma or inflammation; bleedingdisorders;infection, severeischemia, poor 

ISP with Isoflavoneisoflavone+Western fatblend 120 mg of soy isolate(1.3:1 genistein:daidzein)/day and Western fat blend (fish oil control) Diet composition:ND 

received comparable amounts of Western fat blend and/or wheat flourProtein:ND Product:ND Diet composition:ND 

Relaxed aArm circuStrength para

mete

muscle soDelayed OMuscle S(DOMS) Sr total iroCK Cortisol IL-6 TNF-α

Lichtenstein 2002 

Age (yr):62.7 (SD 8.8) Male%:

43% 

Country: US Sites:1 BMI:26.6 Soy1 N:57 Soy2 N:57 Soy3 N:57 Control N:57 

Design:Xover Randomized: Yes Blinding:otherDuration:42 days 

men and women > 50 ywithcholesterol >3.36mmol/L; women were postmenopausalExcluded:meds known toaffect blood lipid levels

1. soy diet with isoflavones isolated soy protien , enriched with isoflavonesISP with IsoflavoneDiet composition:carb 46E, protein 16%, fat 37%, saturated fat 11.3, MUFA 14.4, PUFA 6.1, cholesterol150 per 4.2 MJ2. soy diet without isoflavonesprotein component wascontributed by speciallyprepeared isolated soyprotein, this specific one dep ISP without isoflavone Diet composition:carb 45%,protein 17%, saturated fat12.7, MUFA 14.7, PUFA 6.1, chol 151 per 4.2 MJ

1. animal diet with isoflavonesThe variable protein component wascontributed by dairy and meat.Isoflavones, in the form of a powde Diet composition:carb 48E, protein 15, fat 36, saturated fat 11.8, MUFA14.3, PUFA 5.7, chol 168 per 4.2 MJ2. animal diet without isoflavonesThis diet was designed to mimic anonoptimal diet of a hypercholesterolemic subject. The variable pr Diet composition:Bascially this is the control arm. carb 47E, protein 17%, fat 36%,saturated 12%, MUFA 14.2, PUFA 5.6, cholesterol 154 per 4.2 MJ

Total ChoLDL HDL TriglyceriApo A1 Apo B/10TC:HDL LDL:apoB HDL:apoA

Lissin 2004 

Age (yr):61.7 8.8 Male%:0 

Design:RCT Randomized: Yes 

post menopausal status asdefined by absence of menses prev 12 

mo, or if 

surgically menopausal, age >55; hypercholesterolemic:

phytoestrogensisoflavone tabletsSoy Isoflavones without protein 2 tablets/d

placebo Protein ND Product2 tablets/dDiet composition:ND 

Total ChoLDL Peripheraendotheli

C-34
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Country: US Sites:1 BMI:25.3 Soy1 N:20 Control N:20 

Blinding:double Duration:6 wks 

total chol >200 mg/dl or 5.2 mmol/l , and LDL >125 mg/dl or 3.2 mmol/l and not receiving lipid loweringmedsExcluded:current or recentuse of ERT (within 2 mo); h/o of breast cancer, known atherosclerotic disease; current smoking; more than6 servings of soy/wk

Diet composition:ND 

Lu 1996 

Age (yr): Male%:0 Country: US Sites:1 BMI:ND Soy1 N:6 Control N:0 

Design:NRNCT CohortSing Duration:1 mo 

healthy nonvegeterian women with regular menstrual cyclesExcluded:ND 

Soy milk3 12-oz portions of soy milk(one w/ each meal) daily for 1 mo under the supervision of dietary staf Diet composition: 

No control

Menstrua

length ProgesteDHEA/DH17 b estra

Lu 2000 

Age (yr):32.7 (SD 6.6) Male%: 0 Country: US Sites:1 BMI:71.5 Soy1 N:26 Control N:0 

Design:NRNCT Randomized: No Blinding:N

o

Duration: 4.2 wks 

Healthy premenopausal Excluded:S

moker,

vegetarian, intake > 2 alcohol drinks/week, significant change in wt or eating habits, antibioticstaken preceding 3 mo, irregular menstrual cycles, on contraceptivespreceding 6 

mo

1. Soya-containing diet for one menstrual cycles on site. 2. SoyMilk Diet composition: E 2341, Fat 35.5%E, carb 50.1

%E, 

protein 14.

0%E 

No control

Menstrua

length LH FSH EstradiolProgesteTotal ChoLDL HDL Triglyceri

Lu 2001 

Age (yr):34.4 (SD 5.1) Male%: 0 Country: US 

Design:NRNCT Randomized: No 

Healthy premenopausal Excluded:S

moker,

vegetarian, intake > 2 alcohol drinks/week, significant change in wt or 

1. Soya-containing diet for one menstrual cycles on site. 2. SoyMilk withoutisoflavonesDiet composition: E 2352, Fat 35.9%E, carb 49.8%E, 

No control LH 

FSH EstradiolProgeste

C-35
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Sites:1 BMI:25.8 Soy1 N:9 Control N:0 

Blinding:NoDuration: 3 wks 

eating habits, antibioticstaken preceding 3 mo, irregular menstrual cycles, on contraceptivespreceding 6 mo

protein 14.0%E 

LydekingOlsen 2004 

Age (yr):57.8 (SD 8.4) Male%:0 Country: DenmarkSites:1 BMI:24.0 Soy1 N:26 Control N:28 

Design:RCT Randomized: Yes Blinding:Duration:2 years

At least 1 yearpostmenopausal, with amaximum age of 75 years,had not received any boneactive medication for at least 2 years previously and had at least 3 risk-criteria for osteoporosis: earlymenopause < 45 years of age, low-energy bonefractures Excluded:drug or alcohol addition, malignant disease,immobility, current steroidtreatment, osteomalacia, DM, unstable thyroid disease, severeosteoarthritis in lumbar spine/kip, chronic inflammatory diseases, active liver and kidneydisease 

1. Soy milk rich inisoflavonesSoymilk rich in isoflavonesDiet composition:ND 2. Soymilk w/o isoflavonesSoymilk produced byalsohol washed soy concentrate with only 1.0mg isoflavones /dayDiet composition:ND 

No non soy control Bone min

densityBone mincontent serum-typEquol Type-I C-telopeptidType-I proN-termina

Mackey 2000 11216493

_

study1 

Age (yr):56.40 (SD 4.92) Male%:0 Country: 

Design:RCT Randomized: Yes Blinding:double 

postmenopausal women,45-65.. Fasting cholesterol >5.5 mmol. Excluded:H/o of allergy tosoy, or taking any 

1. ISP- and NHF diet soy protein isolate with content of 4 mg isoflavones/d ISP without isoflavone Diet composition:ND 

No control (compared between soy 1and soy 2) 

TSH Total ChoLDL HDL TriglyceriSerum bo

C-36
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Australia Sites:1 BMI:68.88Soy1 N:22 Soy2 N:24 Control N:0 

Duration:12 wks 

cholesterol lowering drug. 2. ISP+ and NHF diet 

soy protein with isoflavone content of 65 mgisoflavones/d ISP with IsoflavoneDiet composition:ND 

alkaline phosphatSerum OsUrine deoxypyr"menopauSex HormBinding GLH FSH 

Mackey 2000 11216493_study2 

Age (yr):51.5 Male%:100 Country: Australia Sites:1 BMI: Soy1 N:27 Control N:0 

Design:NRNCT CohortSing Blinding:N

o

Duration:12 wks 

Males over 40; fasting total cholesterol >5.5 

mmol/L

Excluded:H/o of allergy tosoy or if taking cholesterol lowering agents

1. ISP+ 28 g ISP with isoflavone content of 65 mg/dISP with IsoflavoneDiet composition:ND 2. ISPsoy protein isolate with content of 4 mg isoflavones/d ISP without isoflavone Diet composition:ND 

No control TSH 

Total ChoLDL HDL TriglyceriSex HormBinding GLH FSH TestosterAndrosteDHEA/DH

Martini 1999 

Age (yr):25.5 Male%:0 Country: US Sites:1 BMI:21.2 Soy1 N:40 Control N:40 

Design:Xover Randomized: Yes Blinding: ND Duration: 8.5 wks 

Women 1

8-40 years from 

the University community,screened initially by phone in response to advertising in university newspapersand fliersExcluded: ND 

Soy diet Soy diet composition: Eachserving provided 104 kcal, 20 g protein, 6 g carb, 

10 fluid oz of skim milkTotal Protein: ND Total Product: 1

0oz

Diet composition: ND 

Menstrualength Sex HormBinding GEstradiolEstrone ProgesteProlactin DHEA/DHRatio ProRatio 2-O

Maskarinec 2002 

Age (yr):43 Male%:0 Country: US Sites:1 

Design:RCT Randomized: Yes Blinding:double 

Premenopausal women 35-46 yr, regular dietaryconsumption of soy foods<7 serving/wk, normal mammogram during the last 6 mo, intact uterus and ovaries, regular menstrual 

Soy_isoflavone_mixture as100 mg tabletsDiet composition: E 1795kcal/d, Fat 60.9g/d 

Placebo tabletProtein Product:100 mg/dDiet composition: E 1705kcal/d, Fat63.5g/d 

Menstrualength Sex HormBinding GLH FSH Estradiol

C-37
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

BMI:ND Weight:145lbsSoy1 N:17 Control N:17 

Duration:12 mo 

periodsExcluded: previous h/o cancer, oral contraceptive or any hormonal replacement, pregnancy,serious medical conditions

Estrone Estrone SProgeste

Maskarinec 2003 

Age (yr):41.1 (SD 3.1) Male%:0 Country: US Sites:1 BMI:23.6 Soy1 N:15 Control N:15 

Design:RCT Randomized: Yes Blinding:double Duration:12 mo 

Women who had received a normal screeningmammogram Excluded:ND 

Soy Isoflavone daily regimen of 100 mg ofSoy Isoflavone mixture equivalent to 76 mgglycosidess Diet composition:E 1735kcal/d; fat 66g 

placebo Protein Product Diet composition: E 1736kcal/d; fat61g 

Mammogdensity

Maskarinec 2004 

Age (yr):43.2 (SD 2.7) Male%:0 Country: US Sites:1 BMI:25.9 Soy1 N:109 Control N:111 

Design:RCT Randomized: Yes Blinding:double Duration:24 mo 

Women who had received a normal screeningmammogram Excluded:Women on oral contraceptives or other sexhormones, diagnosed with cancer, no uterus, one ovary, regular menses, ≥6 

wk serving of soy 

Soy diet Tofu, soy milk, soy nuts, soy protein bar and soyprotein powder Diet composition: 641kcal from soy 

Regular diet Protein:ND Product:ND Diet composition: ND 

E1 E2 Free E2SHBG ProgesteAdione 

McMichaelPhillips1998 

Age (yr):33.5 (SD 8.09) Male%:0 Country: UK Sites:1 

Design:RCT Randomized: Yes Duration:14 days 

women with benign and malignant breast conditionswho were attending clinicsfo women with symptomatic breast problems at the University Hospital of SouthManchester Excluded:menstrual 

Soy bread rolls4 bread rolls daily that contained a total of 60 g soy (in the form of ground textured vegetable pro Textured1 Diet composition: 

normal unsupplemented (without soy) dietProtein ND Product ND Diet composition: 

number ocells in thof the cel progestereceptor e

C-38
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

BMI:ND Soy1 N:19 Control N:29 

irregularities; medication likely to alter pituary function from baseline;consumption of lucagonsor soy-rich diets 

Meinertz1988 

Age (yr):41 (SD 14) Male%:50 Country: DenmarkSites:1 BMI:62 Soy1 N:10 Control N:10 

Design:Xover Randomized: Unclear Blinding:NoDuration:1 mo 

healthy normolipidemicmen and women of normalbody weight, Excluded: smoking, meds

ISP soy protein formula diet Supro ISP with IsoflavoneDiet composition:ISP 140 g, 54 g safflower oil, energy1430 kcal, protein 287 g/l,fat 45 g/l, carb 184 g/l, chol8 mg/l 

casein formula diet Protein119 = 2263/1500*315/4 Product:ND Diet composition:casein 139 g, energy 1500 kcal, protein 315 g/l, fat 43 g/l, carb 198 g/l, chol 46 mg/l. Mean 2263 Kcal/day

Total ChoLDL HDL TriglyceriApo A1 Apo B/10

Meinertz1989 

Age (yr):33 Male%:45 Country: DenmarkSites:1 BMI:64.1 Soy1 N:11 Control N:11 

Design:Xover Randomized: Unclear Blinding:NoDuration:31 days 

healthy normolipidemicmen and women of normalbody weight Excluded:ND 

Soy protein diet ISP without isoflavone Soy protein diet (soyprotein isolate) (Purina 660) Supro Diet composition:energy2477 kcal, 112 g/d protein,fat 75 g/d, carb 338 g/d, chol 486 mg/d

Calcium caseinateProtein121 ProductNd Diet composition:139 g casein, 54 g safflower oil energy 2494 kcal, 121 g/d protein, fat 69 g/d, carb 296 g/d, chol 549 mg/d 

Total ChoLDL HDL Triglyceri

Meinertz2002 

Age (yr):30 (SD 13) Male%:50 Country: DenmarkSites:1 BMI:22.5 

Design:Xover Randomized: Unclear Blinding:NoDuration:32 days 

normolipidemic subjects, mostly medical students. All had normal liver, kidney, thyroid function—none used meds regularly, none used HRT. Excluded:as above 

1 extracted protein 

soy diet

Liquid-formula dietcontaining ethanolextracted soy protein. Supro 670IF=8.2 mg lipid, 0.11 mg iso Supro ISP without isoflavone Diet composition: 

1 intact protein

liquid-formula casein dietProtein Product Diet composition:energy 2494 kcal, 121 g/d protein, fat 69 g/d, carb 296 g/d, chol 549 mg/d

Total ChoLDL HDL TriglyceriLpa 

C-39
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Soy1 N:12 Soy2 N:12 Control N:12 

diet 

Liquid-formula dietcontaining soy protein.Supro 670HG=63 mg lipid, 2.39 mg isoflavone(glycosides)/ Supro ISP with IsoflavoneDiet composition: 

MerzDemlow 2000 

Age (yr):26.3 (SD 4.8) Male%:0 Country: US Sites:1 BMI:64 Soy1 N:20 Soy2 N:20 Control N:20 

Design:Xover Randomized: Yes Blinding:double Duration:3menstrual cycles + 9d

Healthy premenopausal women 18-35 yr, normalmenstrual cycles, not takingantibiotics or oral contraceptives within 6 mo, not taking regular meds, relatively sedentary, 90-120% ideal body lucag, BMI 1

8-25 kg/m2, not 

vegetarian, consumed dietslow in fiber Excluded:h/o of food allergies, smokers, pregnant or lactating 

1 SPI as beverage

powder 

ISP with Isoflavone (high) Diet composition: energy2216 kcal, protein 117.7 g,carb 291.3 g, total fat 67.4, SFA 21.2, PUFA 11, MUFA 15.8, cholesterol 181.8 

1 SPI as beverage

powder 

ISP with Isoflavone (low) Diet composition: energy2275 kcal, protein 114 g, carb 296.9 g, total fat 7

3.7, 

SFA 23.7, PUFA 13, MUFA 17.4, cholesterol 238.5 

soy protein isolates as beverage powder 10mg isoflavone Total Protein: ND Total Product: NDDiet composition:

0.15 with- 0.01 mg

isoflavones, or 10 mg isoflavones/d energy 2277 kcal, protein 115 g,carb 294.2 g, total fat 7

5.8, SFA 

23.7, PUFA 1

2.4, MUFA 20, 

cholesterol 194.3 

Total ChoLDL HDL TriglyceriLpa 

Meyer 2004 

Age (yr):54.0 (SD 1.8) Male%:57 Country: Australia Sites:1 BMI:75.9 Soy1 N:26 Control N:26 

Design:Xover Randomized: Yes Blinding:N

o

Duration:5 wks 

Men or post-menopausalwomen, total plasma cholesterol > 5.5 mmol/l,mildly elevated BP > 140/90mm Hg Excluded:taking meds for either HTN or lipids, low habitual consumption of soyor n-3 foods

soy 4 serving/day (250 ml per serving) consisting of: So Natural Milk: fat 2.9g/100, carb 7.

5 g/100, 

3.1 g protein SoyMilkand yoghurt Diet composition: Energy2100 Kcal, protein 21

%E, 

carb 45%E, fat 29%E, SFA 44%E, MUFA 42%E, PUFA 25%E

4 serving/day (250 ml per serving) oflow fat dairy milk or yoghurt into theirnormal diet nonfat milkProteinND Product Diet composition: Energy 1

900 Kcal,

protein 20%E, carb 43%E, fat 33%E, SFA 36%E, MUFA 36%E, PUFA 30%E

Total ChoLDL 

C-40

HDL TriglyceriLpa SBP DBP Systemic complianc

Mitchell Age (yr): ND Design:NRNC

T 

Healthy, 18 – 35 y males,no significant reproductive

soy_extract subjects received 500 mg 

No control LH 

FSH 
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

2001 Male%:100

Country: UK Sites:1 BMI:ND Soy1 N:15 Control N:0 

Randomized: No CohortSing Blinding:N

o

Duration:2 mo 

medical h/o, normal semen quality, normal seru

m levels

of oestradiol, testosterone,FSH, LH Excluded:Vegetarian, significant reproductivemedical h/o

tablets consisting of standardized soy extract containing 40 mg, in total,Soy Isoflavones without protein Diet composition:ND 

EstradiolTestoster

Morabito2002 

Age (yr):52 3 Male%:0 Country: ItalySites:1 BMI:24 Soy1 N:30 Control N:30 

Design:RCT Randomized: Yes Blinding:double Duration:1 years

Healthy, ambulatory women aged 47-57 who had not undergone surgicallyinduced menopause, had not had a period in the preceding year, and who had a FSH level >50 UI/Land an E2 level of <=100 pmol/L Excluded:Cardiovascular, lucago, or renal disorders,coagulopathy, use of oral or transdermal estrogen,progestin, androgen, or other steroids in the preceding year, smoking habit of more than 2cigarettes per day, previoustreatment with any drug that could affect the skeleton;family h/o estrogendependent cancer; BMD at femoral neck >0.795 g/cm2 

Genistein 54 mg/day. Soy Isoflavones without protein Genistein tablets obtainedfor Lab. Plants (Messina, Italy). The purity of the genisteinDiet composition: Isocaloricfat-restricted diet 30%E from fat, <10% E from sat fat, Cholesterol intake <300mg/d

Placebo tabletsProtein Product Diet composition: Isocaloric fatrestricted diet 30%E from fat, <10%E from sat fat, Cholesterol intake<300mg/d

PTH:1 Bone mindensitySerum boalkaline phosphatUrine deoxypyrUrine pyrBone Gla FSH 

C-41 Estradiol

Murkies1995 

Age (yr):53.8 (SD 1.07) Male%:0 Country: Australia 

Design:RCT Randomized: Yes Blinding:double Duration:12 

postmenopausal women(from interested patients and newspaper ads) with at least 12 mo a

menorrhea,

an FSH >15 mIU/mL, hot flushes>14/wk; nonsmokers; not on antibioticsor HRT for the previous 3 

Soy flour 45 g/d soy flour: the flour was to be taken preferablyraw (eg added to a drink or mixed w/ cereal).Soy diet Soy flour Diet composition:ND 

45 g/d wheat flour: the flour was tobe taken preferably raw (eg added toa drink or mixed w/ cereal Other control: wheat flouProtein Product45 g Diet composition:ND 

Total ChoHDL TriglyceriUrinary caurine hydVaginal cmaturatioFSH 
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Sites:1 BMI:26.5 Soy1 N:28 Control N:30 

wks mo

Excluded:ND 

Equol Menopausymptom flushes, surine ente

Murray 2003 

Age (yr):56.3 7.4 Male%:0 Country: US Sites:1 BMI:24.6 Soy1 N:8 Soy2 N:8 Control1 N: Control

2 N: 

Design:RCT Randomized: Yes Blinding:double Duration:6 mo 

Healthy postmenopausalwomen over 45 years old with an FSH level > 40 mIU/mL and an intactuterusExcluded:Use of 

H

RT 

within 3 mo of initiatingstudy, obesity (BMI > 30),endometrial hyperplasia or cancer, breast cancer, cerebrovascular accident, myocardial infarction, CVD, gallbladder disease, h/o ofthrombosis, active liver disease, undiagnosed ge 

1.ISP with Isoflavone SPI plus 0.5 mg EstradiolProtein powder plus oral micronized estradiol tabletsDiet composition:ND 

1 ISP with 

Isoflavone

SPI plus 1.0 mg EstradiolProtein powder plus oral micronized estradiol tablets:38 g SPI as lucagonspackets containing 2 Diet composition:ND 

1.placebo plus 0.

5mg Estradiol 

Protein:ND Product38 g Diet composition:ND 2.placebo plus 1.

0 mg Estradiol 

Protein:ND Product38 g Diet composition:ND 

Total ChoLDL HDL TriglyceriType 1 Ccross-linkteleopeptEndometthickness 

Nagata 1998 

Age (yr):26.1 7.9 Male%:0 Country: Japan Sites:1 BMI:20.6 Soy1 N:31 Control N:29 

Design:RCT Randomized: Yes CohortMult Blinding:N

o

Duration:2menstrual periods

Fe

male students and

teachers who werepremenopausal and not lucagon in a nursing school course. Excluded:Endocrine disease (DM or adrenal).Taking hormonal medication

Soy.milkInstructed to consume about 400 mL of soymilkdaily. Diet composition:1570 Kcal; Protein 60.0 g; Fat 54.2 g; Cholesterol 231 mg; carb 199 g; Fiber 2.7 g; EtOH 3.6 mL 45.4 g soy products; Isoflavones from soy products 19.4with-15.0 mg 

Continue with their usual diet. Other control: Regular diProtein51.4 g Product Diet composition:Results imply that controls were told to not drink any soy milk. 1486 Kcal; Protein 51.4 g; Fat 48.8 g; Cholesterol 221 mg; carb 202 g; Fiber 2.6 g; EtOH 2.7 mL 0 g soymilk. 43.9 g soy products; Isoflavones from soy products18.4with-1

3.4 mg

Menstrualength Sex HormBinding GEstradiolEstrone 

C-42

Nagata 2001 

Age (yr):32 (SD 8.4) 

Design:RCT Randomized: Yes 

Teachers and students in a nurse school Excluded:Current use of 

soymilkThe soymilk-supplemented group was required to consume 400 ml (408 g) of

habitual diet Protein0 g from soymilkProductND Diet composition:

2030 kcal/day: 72.7

Sex HormBinding GEstradiolEstrone 
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

11303585 Male%:100

Country: Japan Sites:1 BMI:23.3 Soy1 N:17 Control N:17 

Blinding:NoDuration:8 wks 

hormonal medication, diagnosis of prostaticdisease, DM, chronic liver disease, or any endocrinedisease 

soymilk daily for 8 weeks.Diet composition: E 2244Kcal, protein 73.6g/d, fat 77.3g/d, carb 287g/d 

g/d protein, 63.5 g/day fat; 290 g/daycarb

Testoster

Nestel 1997 

Age (yr):54.0 (SD 6.0) Male%:0 Country: Australia Sites:1 BMI:27.0 Soy1 N:21 Control N:21 

Design:Xover Randomized: Yes Blinding:otherDuration:5 wks 

postmenopausal, perimenopausal women Excluded:age > 69 y and HRT, other supplementssuch as vitamin E and primrose oil, meds thatmight affect lipids or CV function, smoking, >14 standard alc drinks/wk

soy isoflavone tabletisoflavone tablet 40g for 5 wks ISP with IsoflavoneDiet composition: <30%E fat 

Placebo tabletProtein Product Diet composition: <30%E fat 

Total ChoLDL HDL TriglyceriMAP PeripheraendotheliSystemic compliancOxidized FBS 

Nikander 2003 12798527 

Age (yr):54 (SD 6) Male%:0 Country: Finland Sites:1 BMI:26.3 Soy1 N:60 Control N: 60

Design:Xover Randomized: Yes Blinding:double Duration:3 mo 

postmenopausal womenwho had been treated for breast CA; no residual malignant disease;incapacitating climactericcomplaints; FSH>30 U/L Excluded:use of sexsteroids includingtamoxifen; use of natural products with possibleestrogenic activity; use ofdrugs possibly affecting climacteric symptoms, ormetabolism or absorption of phytoestrogens (eg, abxduring the previous 3 mo);h/o of any throm 

phyto 6 phytoestrogens tablets(total of 114 mg ofphytoestrogens, an extract of soy isoflavones) per daySSP1 Diet composition:ND 

similar-looking placebo tabletsProtein:0 Product:6 tab/d Diet composition:ND 

Menopausymptom Kupperm

C-43

Work abildepressioSr creatinSex HormBinding GLH FSH EstradiolEquol Other outAnxiety aconfidencaspartatetransaminalanine transamin
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Nikander 2003 14602747 

Age (yr):54 (SD 6) Male%:0 Country: Finland Sites: BMI:26.3 Soy1 N:60 Control N:60 

Design:Xover Randomized: Yes Blinding:double Duration:3 mo 

Post menopausal womenwho were treated for breastcancer previously and devoid of metastasis at recruitment. Patients who had chemotherapy hadbeen discontinued 5 mo to4 yr before recruitment. All women had incapacitating hot flashes and other climacteric symptoms andmenopause confirmed byFSH >30U/L Excluded:FSH <

30U/L and 

taken a course of antibioticswithin previous 3 mo 

phytoestrogen tablet Three phytoestrogen tablets were to be taken every 12 hr with a glass of water (6 tablets/day). Diet composition: ND 

Placebo tabletsProtein:ND Product: 6 tab/dayDiet composition:ND 

C-reactive E-selectinNitrous ox

Nikander 2004 

Age (yr):54 (SD 6) 

C-44 Male%:0 

Country: Finland Sites:1 BMI:25.8 Soy1 N:60 Control N:60 

Design:Xover Randomized: Yes Blinding:double Duration:3 mo 

postmenopausal womentreated for breast cancer 8 mo to 22 yr before. 1) lack of residual malignant disease 2) incapacitatingclimacteric complaints suchas hot flashes, night sweats, sleeplessness 3)FSH >30 U/L Excluded:1) use of sexsteroids such as tamoxifen 2) use of natural productswithpossible estrogenicactivity 3) use of drugsaffectring climactericsymptoms, metabolism, or absorption of phytoesterogens inclantibiotics within 3 mo 4) h/o of thromboembolic or hepatic

Isoflavonoid tablets (Bonette, N

ovomed, 

Helsinki) 1

9 mg of

isoflavoids each. 3 tabletsevery 12 hour Soy Isoflavones without protein Diet composition: ND 

Similar looking placebo Protein:0 Product: ND Diet composition: ND 

Serum boalkaline phosphatUrine deoxypyrUrine pyrType 1 Ccross-linkteleopeptPINP; PIC

Nikander 2004 

Age (yr):54 (SD 6) 

Design:Xover Randomized: 

Post-menopausal womentreated for breast cancer more than 6 mo earlier,

Isoflavonoid tablets (Bonette, N

ovomed, 

Helsinki) 1

9 mg of

Similar looking placebo Protein:0 Product: ND 

Total ChoLDL HDL 
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

15240647 Male%:0

Country: Finland Sites:1 BMI:26.3 Soy1 N:62 Control N:62 

Yes Blinding:double Duration:3 mo 

without metastatis,Incapacitating hot flashesand other climactericsymptoms. At least 6 mopost-menopausal. FSH > 30 U/L.Excluded:HRT, Tamoxifen, statins, natural productswith presumed estrogenicactivity, drugs possiblyaffecting lucagons csymptoms, antibiotics and other substances affecting the metabolism or absorption of phytoestrogens. History of thromboembolic or hepaticevent 

isoflavoids each. 3 tabletsevery 12 hour Soy Isoflavones without protein Diet composition: ND 

Diet composition: ND Triglyceri

Lpa Apo A1 Apo B/10SBP DBP FBS Oral glucotolerance Insulin 

Nilausen1999 

Age (yr): 37 (SD 16.8) Male%:100 Country: DenmarkSites:1 BMI:22.9 Soy1 N:9 Control N:9 

Design:Xover Randomized: Unclear Blinding:NoDuration: 4.2 wks 

active healthynormolipidemic men Excluded:ND 

1 liquid formula 

soy diet

Supro 

C-45

ISP with IsoflavoneDiet composition: dailyintake 154 g, protein constituted ~20E intakecarb ~55E, fat ~25E, chol 55 mg/MJ

caseinTotal Protein: ND Total Product: NDDiet composition:carb ~55E, fat ~25E, chol 55 mg/MJ 

Total ChoLDL HDL TriglyceriLpa 

Onning1998 

Age (yr):31.5 Male%:50 Country: Sweden Sites:1 BMI:20-25 

Design:Xover Randomized: Yes Blinding:NoDuration:4 wks 

healthy nonsmoking volunteersExcluded:ND 

soya milkTofu-line sweetened . Women 750 mL/day; Men 1L/day SoyMilk Diet composition:energy1900 kJ, 30 g protein, 20 g fat, 40 g carb, 5.6 dietaryfiber 

Oat milk medium fat Protein:15g Product Women 750 mL/day; Men 1L/dayDiet composition:energy 1990 kJ, 34 g protein, 17 g fat, 49 g carb 

Total ChoLDL HDL TriglyceriAntioxidaFBS 
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Soy1 N:24 Control N:24 

Pap 1983 

Age (yr):43.9 Male%:56 Country: HungarySites:1 BMI:ND Soy1 N:34 Control N:0 

Design:NRNCT Randomized: No CohortSing Blinding:NoDuration:1 mo 

chronic pancreatitis based on typical h/o, starchtolerance test or limiodoltest or both;pancreaticinsufficiency for 6 mo basedon screening tests Excluded:ND 

soy flourNatural (raw) soy flour (Rakosvolgye Co., Budapest) three times a day, 30 gm in 250 ml water 15 min Diet composition:ND 

No control Lundh Te

measuremTrypsin, LAmylase SecretinPancreozof Trypsin

Pap 1984 

Age (yr):42.6 (SD 2.78) Male%:70 Country: HungarySites:1 BMI:ND Soy1 N:10 Control N:10 

Design:Xover Randomized: Yes CohortMult Blinding:NoDuration:1 mo 

chronic pancreatitisExcluded:ND 

soy flourNatural (raw) soy flour (Rakosvolgye Co., Budapest) three times a day, 30 gm in 250 ml water 15 min Diet composition:ND 

Cholecystokinin octapeptide as intranasal dropsProtein:0 Product:2 dropsx3 times dailyDiet composition:ND 

Lundh tesTrypsin, LAmylase 

Penotti 

C-46

2003 

Age (yr):52.5 Male%:0 Country: ItalySites:1 BMI:23.2 Soy1 N:28 Control N:34 

Design:RCT Randomized: Yes Blinding:double Duration:6 mo 

45-60 yr women; postmenopausal for at least 6 mo; FSH , and 17-BetaE2 levels within the postmenopausal range within the authors’ laboratory; LDL cholesterol <160 mg/dl; no major disease, no HTN, DM, heart disease, renal or peripheralvascular diseasesExcluded: 

isoflavone One gram tablet beforelunch and before dinner. Contains 36 mg of soyderived isoflavonesSoy Isoflavones without protein Diet composition:ND 

one gram tablet twice a day;contains 0.5 g of talc and 0.5 g ofmicrocrystalline celluloseProtein:ND Product1g Diet composition:ND 

Menopausymptom hot flusheEndometthickness pulsatility
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Persky 2002 

Age (yr):59.3 (ISP56) Male%:0 Country: US Sites:multipleBMI:28.0 Soy1 N:24 Soy2 N:23 Control N:25 

Design:RCT Randomized: Yes Blinding:double Duration:24 wks 

completion of menopause, >= 1 y since the lastmenstrual period, and a total plasma cholesterol concentration of 6.2 – 7.8 mmol/L. Excluded: On hormone replacement therapy, other medication to lower cholesterol, h/o of lucagon mellitus or thyroid lucago, chronic illness that affect lipid measurements or limit participation in the study

1 ISP56 

Group patients continue their basal diets to which 40g test protein/d wasincorporated as ISP conta Supro ISP with IsoflavoneDiet composition: 

1 ISP90 

Group patients continue their basal diets to which 40g test protein/d wasincorporated as ISP conta Supro ISP with IsoflavoneDiet composition:ND 

Casein+usual dietGroup patients continue their basal diets to which 40 g test protein/d wasincorporated as casein Protein40 Product:ND Diet composition:ND 

T3 T4 TSH Cortisol Other ENfree thyro Sex HormBinding GFSH EstradiolEstrone Estrone SDHEA/DHSex HormBinding Gbound Urinary 2Urinary 1Equol Insulin:luInsulin Glucagon 

Petrakis 1995 

Age (yr): 29-58 Male%:0 Country: US Sites:1 BMI:ND Soy1 N:24 Control N:24 

Design:NRCT Randomized: No Blinding: NoDuration: Intervention:6mo Follow-up:12 mo 

Pre and postmenopausalwomen volunteered to a prior study on nipple aspirate fluid. Also includedwere nonpregnant women who had yielded breast fluidby nipple aspirationExcluded:ND 

Soy supplement asbeverage Two pkts of ISP 37.4 g of protein 37.4 g of genisteinDiet composition: ND 

Daily diet Historical control Protein:ND Product: ND Diet composition: ND 

Nipple flu  5 EstradiolProgesteSHBG 

C-47

Prolactin CompositmenstruaTotal ChoHDL Triglyceri

Petri 2004 

Age (yr):53.7 (SD 5.45) Male%:0 

Design:RCT Randomized: Yes Blinding:

last menses 12 mo beforestudy, FSH > 40 mIU/L, symptoms of estrogenicprivation (hot flushes) and contraindications or 

soy supple

ment 

4 cap X 500 mg soy germ/d ***These capsules contained soy germ in a glycosilated natural form 

lactose capsmilk1 lactose Protein:ND Product:4cap/day

Total ChoLDL HDL TriglyceriLH 
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Country: BrazilSites:1 BMI:27.97Soy1 N:25 Control N:25 

double Duration:6 mo 

intolerance to conventionalHRT Excluded:veg or macrobiotic diets, Asians, smokers, alcoholics, h/o of chronic GI diseases, use of HRT, tamoxifen orantibiotics within 6 mo, thyroid dysfunctions

isoflavone soy capsule Diet composition:ND 

Diet composition: ND FSH 

EstradiolKuppermmenopau

Potter 1993 

Age (yr):61 Male%:100 Country: US Sites:1 BMI:93.3 Soy1 N:25 Soy2 N:25 Soy3 N:25 Control N:25 

Design:Xover Randomized: Yes Blinding:otherDuration:4wks 

Male outpatients at VAMC, Danville Illinois.Excluded:chol <5.17 mmol/L, hyperlipidemiasecondary to renal disease,med use known to alter lipoid metabolism, BB use for HTN, documentedabnormality of thyroid 

1. soy flour partially defatted extruded soy flour 6.5% fat Diet composition: E ND, protein 20%E, carb 55%E, Fat 25%E 2. soy protein isolate 50 g daily Supro 610 ISP without isoflavone Diet composition: E ND, protein 20%E, carb 55%E, Fat 25%E 3.ISP with cellulose 20 g dietary fiber (cellulose) 

C-48

Diet composition: E ND, protein 20%E, carb 55%E, Fat 25%E 

2. nonfat dry milkDiet composition: E ND, protein 20%E, carb 55%E, Fat 25%E

Total ChoLDL HDL TriglyceriApo A1 Apo B/10

Potter 1998 

Age (yr):59.8 (SD 9.1) Male%:0 Country: US 

Design:RCT Randomized: Yes Blinding:double 

Completion of menopause with >= 1 yr since the lastmenstrual period, plasmacholesterol concentration between 6.2 and 7.8 mmol/L. 

1.ISP56 ISP with IsoflavoneBasal diet + 40 g of soyprotein and 56 mg total glycosides isoflavones/day, Supro 675, Protein Techno2. ISP90 

Casein and non fat dry milk(CNFDM, containing 0 mg total glycosides isoflavones/d; New Zealand Milk Product) Protein40 g Product:ND 

Bone mindensityBone mincontent LDL receTotal choHDL 
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Sites:ND BMI:28.2 Soy1 N:23 Soy2 N:21 Control N:22 

Duration:24 wks 

Excluded:HormoneReplacement Therapy, Anymedications known to lower lipids, h/o of DM 

mellitus or 

thyroid disease, or chronicillness, allergies to soybean protein. 

ISP with IsoflavoneBasal diet + 40 g of soyprotein and 90 mg total glycosides isoflavones/day, Diet composition:ND 

Diet composition:ND Non-HDL 

Total:HDL 

Puska2002 

Age (yr):52 Male%:75 Country: Finland Sites:1 BMI:84 Soy1 N:24 Control N:28 

Design:RCT Randomized: Yes Blinding:double Duration:6wks 

chol 6.9-9.9 mmol/L, Triglyceride <4.

5 mmol/L,

age 17-75 for men, 45-70 for postmenopausal women(at elast 6 mo witho vaginalbleeding). Excluded:any signs of CV, renal, hepatic, endocrine, GI disease; familialhypercholesterolemia, type 1 or 2 DM treated withinsulin, any past orconcomitant use of statins,n-3 or other lipid-l

owering

drugs (incl foods) during past 8 wk. HRT within past 6 mo, no drug or alcoholdependency, no eatingdisorder and no plan for loss of weight 

soyaISP supplement Abacor ISP with IsoflavoneDiet composition:ND 

Milk powder, calcium caseiate, and celluloseProtein Product Diet composition:ND 

Total ChoLDL HDL TriglyceriLpa Apo B/10Homocys

Puska2004 

Age (yr):58 Male%:48 Country: Finland Sites:ND BMI:82.2 Soy1 N:69 Control N:74 

Design:RCT Randomized: Yes Blinding:double Duration:8 wks 

chol 6.9-9.9 mmol/L, Triglyceride <4.

5 mmol/L,

age 17-75 for men, 45-70 for postmenopausal women(at elast 6 mo witho vaginalbleeding). Excluded:any signs of CV, renal, hepatic, endocrine, GI disease; familialhypercholesterolemia, type 1 or 2 DM treated withinsulin, any past or

Soy yogurt 1 cup bid soya protein Diet composition: ND 

placebo yoghurt Protein:1

2.2 

Product:ND 

C-49

Diet composition: ND 

Total ChoLDL HDL TriglyceriSBP DBP Homocys
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

concomitant use of statins,n-3 or other lipid-loweringdrugs (incl foods) during past 8 wk. HRT within past 6 mo, no drug or alcoholdependency, no eatingdisorder and no plan for loss of weight 

Quella2000 

Age (yr): 34, 66 Male%:0 Country: US Sites:1 BMI: Soy1 N:175 Control N:175 

Design:Xover Randomized: Yes Blinding:double Duration: 8 wks 

women >18 yr, h/o of breast CA; currently no residual malignant disease;hot flashes (requiringinterventions) ≥14 

times/week for at least 1 month;life expectancy ≥6 

mo AND Eastern Coop OncGroup score of 0 or 1; tamoxifen or raloxifene Rx is allowed if the pt had started such drug at least 4 weeks before registrationand was planning to continue throughtout the term of the trial Excluded:current or planned Rx with antineoplastic chemo, androgens, estrogens, progestational agents or steroids; agents for hot flashes, like megestrol acetate, clonidine, vit E, belladonna, phenobarb,ergotamine tartrate or other SOY products

soy tablet 600 mg tablet one tablet three times a day for 4 weeks Diet composition: ND 

identical appearing placebo tabletTotal Protein: ND Total Product: NDDiet composition: ND 

hot flash hot flash moderateor very se

C-50 

Rivas 2002 

Age (yr):47.5 (SD 10.4) Male%:14/20 

Design:RCT Randomized: Yes 

Both Men and women with essential HTN asdiagnosed after no cause of HTN was detected after a complete investigation were

Soy milkDiet composition:Supplied by Calcimel, Santivery s.a., Barcelona, Spain Isoflavanoid concentration 

Cow's milk Protein15.5 gramsProduct1 Liter Diet composition:Leche Pasual desnatada (Spain)

SBP DBP Mean blopressure Equol 
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Country: Spain Sites:1 BMI:ND Soy1 N:20 Control N:20 

Blinding:ND Duration:3 mo 

included in the study. Patients had HTN of degree1 or 2 according to the JNC on Detection, Evaluation,and Treatment of High Blood P Excluded:Urinary genistein>100 mu mol/L 

and chemical characteristics in soy milk: Genistein 80 (SD 8); Daidzein 63 (SD 9); EquolND; protein 18 g/L; carb 13.5 g/L; Lipids 10.5 g/L; Calcium 600 mg/L; Energy2 

Isoflavanoid concentration and chemical characteristics in cowsmilk: Genistein ND; Daidzein ND; Equol ND; protein 15.5 g/L; carb 25g/L; Lipids 1.5 g/L; Calcium 600 mg/L; Energy 175 kJ/L 

Ross 1995 

Age (yr):ND Male%:47 Country: US Sites:1 BMI:ND Soy1 N:23 Control N:23 

Design:Xover Randomized: Yes Blinding:ND Duration:9 days 

healthy adults consuming a typical a

merican diet (low in 

fruit and vegetables) Excluded:medical H/o of gastrointestinal symptoms;food allergies; weight lossand gain >4.5kg within the past year; major changes ineating habits within the lastyear or significant shortterm dietary changes (such as seen with high intensityexercise regimens, alcohol intake >

2 drinks/d, OCD by

women, smoking and unwillingness to consume all foods provided

Soy diet Tofu control diet plus dailyservings of firmed tofu and 45g FriChick, a textured vegetable protein product Diet composition:ND 

commonly consumed foods and nofruits and vegetables and wasessntially phytochemical freeProtein:ND Product:ND Diet composition:ND 

Platelet dgrowth faPDGF-AABB  mitogeni

Russo2003 

Age (yr):53.3 

C-51

(SD 3.3) Male%:0 Country: ItalySites:1 BMI:26.3 Soy1 N:50 Control N:50 

Design:Xover Randomized: Yes Blinding:double Duration:3 mo 

Recent menopause, 48 - 54y, Caucasian, Neg PAP test, normal pelvic US, symptoms of Climactericsyndrome Excluded:Surgical h/o for genital or mammaryneoplasia, HRT within 6 mo, arterial hypertensionand/or cardiovascular pathologies, endocrinological pathologies, nicotinism, obesity, alcohol or narcotic

isoflavonesComercially available preparation based on phyto-oestrogens against a placebo Soy oil, 5 mcg vitamin D, Diet composition:ND 

Comercially available preparation based on phyto-oestrogens against a placebo Protein:ND Product:ND Diet composition:ND 

Menopausymptom hot flushe
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

abuse 

Sagara 2004 

Age (yr):52.2 (SD 3.9) Male%:100 Country: UK Sites:12 BMI:27.6 Total enroll:61 Soy1 N:25 Control N:25 

Design:RCT Randomized: Yes Blinding:double Duration:5 wks 

Systolic blood pressure 130 mmHg or higher and/orTotal Cholesterol 220 mg/dL or higher. Excluded:Presence of DMmellitus and any other chronic illnesses that could affect BP or blood lipidconcentration or limit individual's ability toparticipate in the study, and use of anti-hypertensive drugs, cholesterol lowering drugs and any medication kn

Soy powder Soy powder mixed incereals, biscuits and bread rolls were consumed inaddition to the usual diet. Diet composition:ND 

placebo group Other control: cereals, b Protein26.7 g Product Diet composition:ND 

Total ChoHDL SBP DBP non HDL-non HDL-ratio 

Saxena 1999 

Age (yr): Male%:Country: India Sites:1 BMI:ND Soy1 N:45 Control N:0 

Design:NRNCT Randomized: No CohortSing Duration:3mo 

Patient with platelet functional defect and withlab test available for PCI, PF3 availability and platelet aggregation studiesExcluded:ND 

Soya Bean, consumed in the form of boiled beans, soya flour or soya milk. Soy bean SoyMilkSoy diet soya flourDiet composition:ND 

No control Miscellan

outcomesBleedingPlatelet s

Scambia 2000 

Age (yr):54 (SD 7.1) Male%:0 Country: ItalySites:1 BMI:26.2 Soy1 N: 20 

Design:RCT Randomized: Yes Blinding:double Duration:10 wks 

Postmenopausal women:spontaneous amenorrhea at least 12 mo, surgical or early menopause; and Ecarb endomerial thickness<4.5 mm; negative X-raymammograpphy; metabolicand biochemical indexwithin normal range Excluded: involved in anyclinical trial 6 mo before

1. Soy tablet 12% isoflavones and 35%saponins. 200 mg SOYSELECT, lactose, cellulose microcrystalline, sillica colloidal, and sodium Mg stearicSoy Isoflavones without protein Diet composition: ND 

Placebo tb contained lactose, cellulose microcrystalline, sillica colloidal, and sodium Mg stearicTotal Protein: ND Total Product: NDDiet composition: ND 

PTH Total ChoLDL HDL TriglyceriEndotheliSerum OsVaginal cmaturatioMenopausymptom vasomoto

C-52
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Control N:19 entering this study symptom

Greene cscaleEndometthickness Pulsatility uterine arLH FSH Prolactin 

Scheiber 2001 

Age (yr):55.5 (SD 5.2) Male%:0 US:1 Country: US Sites:1 BMI:27.1 Soy1 N:42 Control N:0 

Design:NRNCT Randomized: No Blinding:N

o

Duration:12 wks 

Menopausal (either natural or surgical) women withamenorrhea for > 6 mo and an FSH level > 23 IU/L atenrollment.Excluded:Women on estrogens, progestins, androgens, corticosteroids,or antioxidant drugs within the 4 mo before enrollmen, or on a full course of antiobiotics within 3 mo of enrollment, or h/o of estrogen-dependent 

Soy Nuts Whole soy nuts (10 gm/serving) or commercially available soymilk drinks (SoGood, 250mL/serving). SoyMilkSSP1 Diet composition: 

No control Total Cho

LDL HDL TriglyceriOxidized Serum boalkaline phosphatSerum OsType 1 Ccross-linkteleopeptFSH Estradiol

Secreto 2004 

Age (yr):53 Male%:0 Country: ItalySites:3 BMI:Median23.8 Soy1 N:65 Soy2 N:64 Control N:67 

Design:Factorial Randomized: Yes Blinding:double Duration:3 mo 

Postmenopausal womenaged >= 35 years; lastmenstrual flow > 

6 mo 

before recruitment; anycondition for which classicHRT is not recommended Excluded:Breast cancer therapy or HRT during the previous 3 mo; overt endocrinopathy (DM, hyperthyroidism etc.); intolerance to soy

1. Soy isoflavones Each soy capsulecontained 300 mg of soyextract, equivalent to 40 mgof isoflavones.Soy extract Diet composition:ND 2. Isoflavone+melatonin Each soy capsulecontained 300 mg of soyextract, equivalent to 40 mgof isoflavones.Soy extract Diet composition:ND 

Placebo sorbitolProtein0 Product2 identical capsules per dayDiet composition:ND 

Greene CScale PsycholosubscaleSomatic sVasomoto

C-53
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Shorey1981 

Age (yr):26 (SD 4) Male%:100 Country: US Sites:1 BMI:79.1 Soy1 N:14 Control N:13 

Design:RCT? Randomized: Unclear Blinding:ND Duration:6 wks 

Mildly hypercholesterolemicmales from the student and Faculty population at the University of Texas atAustin and those who gaveinformed consent for the studyExcluded:ND 

Soy protein diet Soy analogs and soy milkSoy diet SoyMilkDiet composition: Energy2469 with-137 kcal; Protein87with-7g; carb 333with26g; Fiber 7with-2 g; Fat 93with-7 g; Sat fat 33gcholesterol 183 

Animal protein dietOther control: RestructurProtein58.5 g Product Diet composition: 2400 kcal with 13to 15% of energy from protein, 30 to 35% from fat and remainder from carb. 

Total ChoHDL TriglyceriHDL-C/Tocholester

Simons 2000 

Age (yr):59 Male%:0 Country: Australia Sites:1 BMI:26.8 Soy1 N:23 Control N:23 

Design:Xover Randomized: Yes Blinding:double Duration:8wks 

Healthy postmenopausalvolunteers 50-70 yr (LMP >12 mo), significant endothelial dysfunction, nonsmoking, cholesterol <8.0 mmol/L and Triglyceride <3.0Excluded: Cardiac renal, hepatic disease or DM. Vitamins, and mineralssupplementation, lipidregulating drugs, warfarin, antihypertensive medications, sex hormones

Phytoestrogen (PE) tabletsbid Soy bean Diet composition: isocaloricfat restricted diet, 30%E fat,<10% E sat fat, cholesterol <300 

placebo Total Protein: ND Total Product: NDDiet composition: isocaloric fatrestricted diet, 30%E fat, <10% E sat fat, cholesterol <300 

Total ChoLDL HDL TriglyceriLpa BP PeripheraendotheliGlyceryl tinduced dFlow meddilation

Sirtori 1999 

Age (yr):51.9 (SD 13.5) Male%:38 Country: Italy

Design:Xover Randomized: Yes Blinding:

Severe hypercholesterolemia (13 genetic, 8 sporadic) with cholesterol >7.8 mmol/Land LDL >5.8 mmol/L in absence of drug tx, 

Soya milk supplemented diet Diet composition:500 mlfluid milk to achieve 7%protein content energy

Cows' milk supplemented diet Total Protein: 70g/d Total Product: 500ml Diet composition: 2 dietaryschedules 1400 kcal (carb 56.7, fat 25.1, protein 18.2) and 2000kcal 

Total ChoLDL HDL TriglyceriSBP DBP 

C-54
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Sites:1 BMI:24.4 Soy1 N:21 Control N:21 

double Duration:4wks 

Triglyceride <2 

mmol/L

Excluded:type I or II DM, alcoholism or alcohol liver disease, severe ailments:cancer, degenerative mental disease, heart or kidney failure

1124 kJ/d, protein 70 g/l, fat 22 g/l 2 dietary schedules 1400kcal and 2000kcal

(carb 59.9, fat 24.3, protein 15.8) FBS 

Sirtori 2002 

Age (yr):59.5 8.35 Male%:20 Country: ItalySites:1 BMI:24.2 Soy1 N:20 Control N:20 

Design:Xover Randomized: Yes Blinding:double Duration:4 wks 

type II hypercholesterolemicswithcholesterol >7 mmol/L,LDL >5.

5. 

Excluded:alc intake >4 standard drinks/d or >40 g alcohol/d, diabetics on meds or insulin, SBP >160mm Hg or DBP >95. Medsfor dyslipide

mia or agents

that affect lipids, vegetarians or those consuming >1 soycontaining milk serving/d 

Soya milk supplemented diet Diet composition:

500 ml

fluid milk to achieve 7%protein content energy1124 kJ/d, protein 70 g/l, fat 22 g/l 2 dietary schedules 1400kcal and 2000kcal

Cows' milk supplemented diet Total Protein: 70g/d Total Product: 500ml Diet composition: 2 dietaryschedules 1400 kcal (carb 56.7, fat 25.1, protein 18.2) and 2000kcal (carb 59.9, fat 24.3, protein 15.8) 

Total ChoLDL 

Soroka 1998 

Age (yr): 30-85 Male%:56 Country: Israel Sites:1 BMI:ND Soy1 N:15 Control N:15 

Design:Xover Randomized: Yes Blinding:ND Duration:6 mo 

CRF patients, CrClbetween 15 and

50

ml/min/1.73 m2 and the 24-hour urinary protein excretion < 3 g/day/1.73 m2 (i.e. no patient hadnephrotic syndrome) Excluded:DM or other syste

mic diseases

Vegetable protein diet(VPD): (1) soya-based schnitzels, hamburger, andsausage (2) Soy drinkDiet composition: E 2,049kcal/d, protein 48.9g/d, carb 54.

5%E, fat 

35.8%E, proteins 9.45%E

Animal-protein diet (APD) 50%protein from eggs, chicken, meat,turkey, fish, and milk; 50% protein from bread. Protein:0.75 g/kg/dayProduct:ND Diet composition: E 1,838 kcal/d, protein 52.5 g/d, carb 55.5%E, fat 33.3%E, proteins 11.1

3%E 

Total ChoLDL HDL TriglyceriGFR Sr creatinBUN serum albUrinary ca

C-55
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Squadrito 2002 

Age (yr):54  (SD 7) Male%:0 Country: ItalySites:1 BMI: ND Soy1 N:30 Control N:30 

Design:RCT Randomized: Yes Blinding:double Duration:6 mo 

healthy a

mbulatory women 

aged 52-60 who had not undergone surgicalmenopause, had nomenstrual cycle inpreceding yr, FSH > 50 IU/L, estradiol <1

00 pmol/L. 

Excluded:any clinical or lab abnormailities thatsuggested cardi

ovasc,

hepatic, or renal disorders;coagulopathy; used oral or transdermal estrogen,progestin, androgen orother steroids in precedingyr; smoked >10 cigs/d; had taken cholesterol-l

owering

or CV meds

genistein genistein 54 mg/dDiet composition:isocaloricfat restricted diet 30%E fat, 10%E from sat fat, chol <300 mg/d

placebo Protein:ND Product:ND Diet composition:isocaloric fatrestricted diet 30%E fat, 10%E fromsat fat, chol <300 mg/d 

Total ChoLDL HDL TriglyceriSBP DBP EndotheliPeripheraendotheliEstradiol

Squadrito 2003 

Age (yr):56 (SD 7) Male%:0 Country: ItalySites:1 BMI: Soy1 N:27 Control N:26 

Design:RCT Randomized: Yes Blinding:double Duration:12 mo 

healthy a

mbulatory women 

aged 52-60 who had not undergone surgicalmenopause, had nomenstrual cycle inpreceding yr, FSH > 50 IU/L, estradiol <1

00 pmol/L. 

Excluded:clinical or lab abnormailities thatsuggested cardi

ovasc,

hepatic, or renal disorders;coagulopathy; used oral or transdermal estrogen,progestin, androgen orother steroids in precedingyr; smoked >10 cigs/d; had taken cholesterol-l

owering

or CV meds. 

genistein genistein 54 mg/dSoy diet genistein Diet composition:ND 

placebo ProteinND Product ND Diet composition:ND 

PeripheraendotheliEndothelivascular Estradiol

C-56
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

St Germain 2001 

Age (yr):50 Male%:0 Country: US Sites:1 BMI: ND Soy1 N:24 Soy2 N:24 Control N:21 

Design:RCT Randomized: Yes Blinding:double Duration:12 wks 

nonsmoking peri

menopausal women, 

experiencing at least nd hotflushes and/or night sweats/week, within 12minths of their lastmenstrual cycle, free fromchronic disease or chronicmedication use, not takingHRT or ERT during the time of the study or 1

2 m 

Excluded:FSH < 

30 IU/mL 

1. SPI+ Soy protein isolate with isoflavones (Supro)Diet composition: 2. SPISoy protein isolate without isoflavones (Supro)Diet composition:ND 

Whey protein control Total Protein: 40Total Product: NDDiet composition: ND 

Menopausymptom hot flush Other symMenopau(to measuflush and sweat freduration aseverity) 

Steinberg 2003 

Age (yr):54.9 (SD 1.0) Male%:0 Country: US Sites: BMI:24.6 Total enroll:42 Soy1 N:28 Soy2 N:28 Control N:28 

Design:Xover Randomized: Yes Blinding:double Duration:6wks 

healthy postmenopausalwomen; Excluded:HRT use within 6 mo, hyperlipidemia (chol >5.17 mmol/L or 200 mg/dL), meds to treat highBP or hypercholesterolemia, GI abnormalities affecting dietary intake, prev heart attack or dx heart disease, hepatic or renal disease, DM, h/o of thrombosis or blood 

ISP w/ isoflavones ISP w/ naturally occurring isoflavonesISP with IsoflavoneDiet composition:

25 g 

protein, 1g fat energy 7.6 MJ, carb 247.9g/d, protein 89.6 g/d, total fat 52.4 g/d, saturated fat15.5 g/d, chol 164.4 mg/d, fiber 21.6 mg/dISP w/o isoflavonesethanol-washed ISP w/ trace a

mounts of 

isoflavonesISP without isoflavone Diet composition:

24 g 

protein, 1 g fat energy 7.2 MJ, carb 225.7g/d, protein 84.3 g/d, total fat 52.1 g/d, saturated fat16.3 g/d, chol 175.9 mg/d, fiber 19.4 mg/d

total milk protein Protein25 g Product Diet composition:energy 8.0 MJ, carb 263.7 g/d, protein 91.1 g/d, total fat 55.3 g/d, saturated fat 17.1 g/d,chol 178.1 mg/d, fiber 21.2 mg/d 

Total ChoLDL HDL TriglyceriPeripheraendotheliOxidized E-selectinEndotheliNitrous oxVCAM-1 ICAM 

Stroescu2001 

Age (yr):14.9 (SD 1.3) Male%:0 

Design:RCT Randomized: Yes Blinding:

Elite female gymnasts, members of the R

omanian

Olympic Tea

m with pri

mary

amenorrhea (13/14

ISP Daily supplementation of 1 g of soy protein per kg bodyweight in the form of cocoaflavoured bevera 

placebo beverage: 10 g sugar, 3 g cocoa, 250 ml water. The totalprotein ratio per day and kg was 2. Protein without fatnone repor 

Total ChoT3 T4 serum: prtotal fat, F

C-57
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Country: Romania Sites:1 BMI:33.1 Soy1 N:7 Control N:7 

double Duration:4 mo 

gymnasts) Excluded: ND 

Supro Isolated S

oy Protein, 

unclear re: IsoflavonesDiet composition: ND 

Total Protein: 2.8/Kg BW Total Product: NDDiet composition: protein amount ishigher in controls than in Txsubjects; type of protein in controlsnot specified 

SGOT, SCa, Mg, IIgG; urine mucoprotSr creatinBUN EstradiolProgesteProlactin Testoster17-ketostmetabolitandrogen

Swain 2002 

Age (yr):50.2 (SD 3.6) Male%:0 Country: US Sites:1 BMI:24.1 Soy1 N:24 Soy2 N:24 Control N:21 

Design:RCT Randomized: Yes Blinding:double Duration:24 wks 

peri

menopausal women 

throughout Iowa and bordering states; >/= 10 flushes/wk; irregular menses or menstrual period cessation; FSH./=30 IU/L; BMI=20-31; no chronicdisease; no excessivelyexercising; one or bothovaries remaining; able and willing to participate Excluded:chronic disease; routine use of medications;smoking; alcohol abuse; estrogen or HRT during the prior 12 mo; H/o of eatingdisorders

1. Isoflavone poor SPI 40g/day w/ 50% of thisprotein incorporated into a muffin and the 50% as a powder that subject 2. ISP without isoflavone Isoflavone rich SPI 40g/day w/ 50% of thisprotein incorporated into a muffin and the 50% as a powder that subject ISP without isoflavone Diet composition:ND 

whey protein: 40g/day w/ 50% of thisprotein incorporated into a muffin and the 50% as a powdeProtein40 g ProductND Diet composition:ND 

Total ChoLDL HDL Lpa FSH Estrone 17b-estraserum ferserum irotransferrin saturation Hb conceanthropommeasurem

Takatsuka 2000 

Age (yr):26.1 (SD 7.6) Male%:100 Country: Japan Sites:1 BMI:20.4 Total enroll:60 

Design:RCT Randomized: Yes Blinding:double Duration:2 mo 

all premenopausal femalestudents and teachers at Gifu Nursing SChool. Excluded:h/o of endocrinediseases and HRT, chronichepatitis or CVD. Total Chol>220 mg/dl or Triglyceride >160. 

soy supple

ments

400 ml (408 g) commercial regular soymilk/d.Diet composition: E 1569 kcal/d, protein 59.9g, fat 54.5g, carb 197.

5g

usual dietTotal Protein: ND Total Product: NDDiet composition: E 1491 kcal/d,protein 50.7g, fat 50.2g, carb 200g 

Total ChoLDL HDL Triglyceri

C-58
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Soy1 N:27 Control N:25 

Teede 2001 

Age (yr):61 (SD 1) Male%:53.6 Country: Australia Sites:1 BMI:25 Soy1 N:105 Control N:108 

Design:RCT Randomized: Yes Blinding:double Duration:3 mo 

Healthy participants men and women 50-75 yrExcluded:no antibi

otics or 

soy products or suppls for 3 mo, no estrogen therapy for 3 mo;moderate to severe menopausal symptoms,smoking over past 10 yr, alcohol consumption >30 g/d, hypertension, abnormal uterine bleeding, cervical cytology, or ma

mmogram 

and coexistent major illness

soy ISP w/isoflavones, 2 sachets/d28 g powdered ISP ISP with IsoflavoneDiet composition: ND 

caseinTotal Protein: ND Total Product: NDDiet composition: ND 

Total ChoLDL HDL TriglyceriLpa SBP DBP PeripheraendotheliSystemic compliancpulse wavLH FSH Testoster

Teede 2004 

Age (yr):61 (SD 1) Male%:0 Country: Australia Sites:1 BMI:26 Soy1 N:30 Control N:20 

Design:RCT Randomized: Yes Blinding:double Duration:3 mo 

postmenopausal women50-7

5 yr with 12 

mo

amenorrhea and FSH >20IU/L Excluded:no antibi

otics or 

soy products or suppls for 3 mo, no estrogen therapy for 3 mo; moderate to severe menopausal symptoms,smoking over past 10 yr, alcohol consumption >30 g/d, HTN, abnormal uterine bleeding, cervical cytology, or mammogra

m result and 

coexistent maj

or illness.

soy ISP with IsoflavoneDiet composition: ND 

Casein placebo Protein:ND Product:ND Diet composition:ND 

TBG C-reactive Sex HormBinding GLH FSH DHEA/DH

Teixeira 2000 

Age (yr):43.3 (SD 11.4) Male%:100 Country: US Sites:1 

Design:RCT Randomized: Yes Blinding:double Duration:6

Free living men age >23,Total Cholesterol 5.69-7.76mmol/L, BMI 20-

33

Excluded:DM, thyroid disease, chronic disease that affect lipids, anymedication that affect lipds. 

1. 20 g Supro Plus 675HG plus 30 g casein ISP with Isoflavone2. 30 g Supro 675HG plus20 g caseinISP with Isoflavone3. 40 g Supro 675HG plus10 g casein

50 g caseinTotal Protein: 50 g Total Product: NDDiet composition:NCEPstepI diet 30%E fat, <10%E sat fat, <300mgcholesterol/d 

Total ChoLDL HDL TriglyceriLpa Apo A1 Apo B/10

C-59
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

BMI:27.1 Soy1 N:15 Soy2 N:18 Soy3 N:17 Soy4 N:15 Control N:16 

wks Weight variation >

3 kg

during the study.

ISP with Isoflavone50 g ISP 4. 50 g Supro 675HG Supro ISP with IsoflavoneDiet composition:NCEPstepI diet 30%E fat, <1

0%E sat 

fat, <300mg cholesterol/d 

Tonstad 2002 

Age (yr):51.4 (SD 9.8) Male%:83 Country: NorwaySites:2 BMI:24-25 Total enrol: 159 Soy1 N:34 Soy2 N:31 Control N1:29 Control N2:36 

Design:RCT Randomized: Yes Blinding:double Duration:16 wks 

Men aged 30-70 yr andpost menopausal womenaged 45-70 yr with total cholesterol 5.8-7.9 mmol/Land triacylglycerol conc<4.5 mmol/L were eligibleExcluded:Significant CVD, renal , GI, endocrine disease, including DM type 1 and 2 treated with drugs;familial hypercholesterolemia;obesity (BMI >=30) anduncontrolled HTN (BP >160/100 mmHg), plan tolose weight during the study, alcohol consumption 28units/wk, intake of statins, n-3 supplements,other lipid lowering drugsand women on HRT within6 mo of study

1. ISP 30g Isolated soy protein 30gram available as ready tomix beverage ISP with IsoflavoneDiet composition:  2. ISP 50g Isolated soy protein 50g available as ready to mixbeverage ISP with IsoflavoneDiet composition:<

30% E

fat, <1

0%E sat fat, <300 

mg cholesterol/d 

Casein 30g and 50g Protein30g and 50g Product Diet composition:<

30% E fat, <10%E

sat fat, <300 mg cholesterol/d 

Total ChoLDL HDL TriglyceriLpa Apo B/10SBP DBP HomocysFibrinogeAlpha Tocmu mol/Lfolate 

Uesugi 2002 

Age (yr):51.8 (SD 1.9) Male%:0 Country: Japan Sites:1 BMI:22.9 

Design:RCT Randomized: Yes Blinding:double Duration:4 

healthy perimenopausal employees of a food processing factory age 40-62 Excluded:ND 

soybean isoflavone extract Isoflavone onlyDiet composition:ND 

placebo capsulesProtein:ND Product:ND Diet composition:ND 

Total ChoLDL HDL TriglyceriSerum OsUrine deoxypyrUrine pyrBone stiff

C-60
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Soy1 N:12 Control N:11 

wks HgbA1c

Uesugi 2003 

Age (yr):53.7 (SD 6.9) Male%:0 Country: Japan Sites:1 BMI:52.0 Soy1 N:11 Control N:10 

Design:RCT Randomized: Yes Blinding:double Duration:3 mo 

age 45-65, 5-1

0 yr after

natural menopause, weight35-70 kg, no evidence of disease associated withosteoporosis or other med problems, no h/o of druguse, including estrogen, known to affect bone metabolism Excluded:as above 

isoflavone extract Soy Isoflavones without protein Diet composition:ND 

dextrin Protein:ND Product:2 times dailyDiet composition: 

Total ChoHDL TriglyceriUrine pyrUrinary cavaginal pacytologyFSH 

Unfer 2004 

Age (yr):49 (SD 4.3) Male%:0 Country: ItalySites:1 BMI:67 Soy1 N:179 Control N:197 

Design:RCT Randomized: Yes Blinding:double Duration:5 years

intact uterus, absense of menses for 12 mo, FSH >30 IU/L, body weight range within 20% normal weight Excluded:any medscontaining estrogens,progestins, androgenswithin 8 wks of trial, presence of endometrial hyperplasia 

phytoestrogens3 tablets/d soy=150 mgisoflavonesSoy Isoflavones without protein Diet composition:ND 

Placebo tabletsProteinND Product:3/dayDiet composition:ND 

Endometthickness 

Upmalis 2000 

Age (yr):54.8 (SD 4.9) Male%:0 Country: US Sites:15 BMI:152.2 Soy1 N:89 Control N:86 

Design:RCT Randomized: Yes Blinding:double Duration:12 wks 

Healthy postmenopausalwomen age 50 years or older and in good overallhealth, with a BW within =-35% range for BMI, FSH levels of 40 mIU/mL or more, E2 levels of 25 pg/mL or less, and an average of 3 or more vasomotor symptoms perday. Subjects havediscontinued Excluded:H/o of breast 

Soy isoflavone extract tablet (with little protein) Diet composition: ND 

Placebo Total Protein: ND Total Product: NDDiet composition: ND 

Total ChoLDL HDL TriglyceriSerum OsType 1 Ccross-linkteleopeptEndometthickness FSH Hot flusheNight swe

C-61
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

cancer, hyperplasia, endometrial carcinoma, or cervical neoplasia; a positive pregnancy test'undiagnosed abnormal vaginal bleeding, a bilateraloophorectomy or hysterectomy; thromboembolic disorders;h/o of CVDs; liver disease; h/o chronic alcoholism, medication hypersensitivity,or allergy to dietarysupplement, uncontrolledaddiction or severedepression, acute systemic infection or abnormal lab values

Van HornL 2001 

Age (yr):66.6 Male%:0 Country: US: Sites:1 BMI:26.6 Soy1 N:32 Control N:32

Design:RCT Randomized: Yes Duration:6 wks 

Age > 50 yr and/orconfirmed post menopausal status, Total Cholesterol concentrations above 5.17mmol/L on average with two screenings, and BMI <35. Additional eligibility criteria: not being on a weight lossdiet; not taking fiber, soy or other dietary suppleme Excluded:Subjects allergicto soy, milk, or oats were excluded. 

1. Oats/soy 2. Wheat/soySoy protein powderISP without isoflavone Diet composition: E ~1400, total fat 24%E, protein 18-19%E

1. Oats and milk arm Protein without fatTotal Protein: ND Total Product: 29 gram Diet composition:The oat group incorporated 2 servings (56 g dryweight) of cooked oatmeal or (2oz) ready to eat oat bran cereal per day. Non fat milk protein powder servedas the control product for soy2. Wheat+milkCream of wheat or a non-oat readyto eat cereal and non fat milk protein powder Total Protein: ND Total Product: NDDiet composition: Diet composition:E ~1400, total fat 23%E, protein 18-19%E

Total ChoLDL HDL 

Van Patten CL 2002 

Age (yr):55.5 (SD 8.9) 

Design:RCT Randomized: Yes 

Breast cancer pts > 4 mosince cancer tx, menopausal, moderate hot 

soy milkSoybean beverage, 250 mL twice per day, was vanilla flavored, with similar calorie 

Rice beverage as placebo, 250 mLof study beverage twice a day,vanilla flavored with similar calori milk1 

Menopausymptom 

C-62
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Male%:Country: Canada Sites:MultipleBMI:26.8 Total:157 Soy1 N:59 Control N:64 

CohortMult Blinding:double Duration: 

flashes (score => 10 wk) Excluded:Amenorrhea < 12 mo, HRT preceding 4 mo, smokers, antibiotic use, IBD, liver impairment, recurrent breast cancer. allergies, consumed soyfoods

& fat content SoyMilkDiet composition:Donated by Soya World Inc in BC, Canada 

rice milkProteinND Product250 mL 2 @ dayDiet composition: 

hot flashe

Verrillo 1985 

Age (yr):Male 48;Female 54 Male%:44% Country: ItalySites:1 BMI:28.0 Soy1 N:44 Soy2 N:22 Control N:0 (66 on 8 wk low fat diet) 

Design:RCT Randomized: Yes CohortMult Blinding:NoDuration:16 wks 

Stable hypercholesterolemia.Total Cholesterol > 7.8 mmol/L and LDL > 4. Excluded:Clinical or biochemical evidence of cardiac, renal, hepatic orendocrine disease.

1.Soy.Addition Cholsoy granules (60 g/day) as a supplement to the low fat diet. Diet composition:Actual: 2353 Kcal, Protein 19.7%(animal 8.5%, soy 5.3%),Fat 31.0%, Sat fat 6.5%,MUFA 11.5%, PUFA 13.0%, carb 49.3%,Cholesterol 205 mg2.Soy.Substitution Animal proteins replacedwith Cholsoy (Gipharmex, Milan), a soybean preparation (26.5% carb, 5% sucroDiet composition:Actual: 2150 Kcal, Protein 15%(animal 2.3%, Soy 5.8%), Fat 33.5%, Sat fat 7.4%,MUFA 11.4%, PUFA 14.7%, carb 51.5%,

No non soy control Total Cho

LDL HDL Triglyceri

C-63
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Cholesterol 188 mg

Vigna 2000 

Age (yr):53.8 (SD 3.1) Male%:0 Country: ItalySites:2 BMI:25.9 Soy1 N:51(46+5post initial randomization) Control N:53(46+7 post initial randomization) 

Design:RCT Randomized: Yes Duration:12 wks 

Post menopausal womenwith hot flushes. Amenorrhea for at least 6 mo or bilateraloopherectomy at least 6 wks earlier. Severe hot flushes (>7/24 hr); baselineFSH > 50 IU/L, Serum estradiol < 130 pmol/L; TSH and thyroxine normal. Excluded:ND 

Soy.powder Replace breakfast with beverage containing 60 gsoy powder (ISP, Supro brand) and to increase liquid intakeSupro ISP with IsoflavoneDiet composition:ND 

Replace breakfast with beverage containing 60 g caseinate powder and to increase liquid intake. TotalProtein: 40 gTotalProduct: 60 gDiet composition: ND. 

LDL:HDL Total ChoLDL HDL TriglyceriLpa Apo A1 Apo B/10SBP DBP 

Wangen 2000 2 parallel studies (1post- and 1 premenopausal women) 

Age (yr):14 pts(peri) 26.5;17pts (post) 57.1 Male%:0 Country: US Sites:1 BMI:14 pts (peri) 63.4; 17 pts(post) 65.5 Soy1 N: 14 

Design:Xover Randomized: Yes Blinding:double Duration:3 mo 

premenopausal orpostmenopausal women Excluded:strict vegetarian,high fiber, high soy, or low fat diets; regular vitamin and mineralsupplementation>Recommended DietaryAllowances; athleticism; cigarette smoking; antibioticor hormone use within sixmo; bleeding within 12 mo; hysterectomy or 

1. Isolated soy proteinpowder ISP with Isoflavone (high) Diet composition: energy1.21 MJ or 290 kcal, protein 53g, carb 15 g, fat 1.9 g inpremenopausal study; energy 1.46 MJ or 349 kcal, protein 63g, carb 21 g, fat 1.9 g in postmenopausalstudy. 2. Isolated soy proteinpowder

ISP powder containing 10 + 1.1 isoflavones/d (14 premenopausal) ISP powder containing 7 + 1.1isoflavones/d (17 postmenopausalsubjects) Total Protein: ND Total Product: NDDiet composition: E 1799kcal, protein 111g, carb 242g, fat 46g, fiber 13g 

Bone spealkaline phosphatOsteocalcDeoxypyrcross-linkIGF-I IGFBP3 Carboxy telopeptidcollagen 

C-64
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

(peri); 17 (post) Soy2 N: 15 (peri); 17 (post) Control N: 1

4

(peri); 17 (post) 

oopherectomy; FSH concentration of less than 25 IU/L; history of chronicdisorders, endocrine orgynecological diseases; benign breast disease; regular use of medication known to interfere with study endpoints (including aspirin); less than 90% or more than 1

20% ideal body

weight; weight change >10 lb within the previous year, and inability to abstain fromalcololic beverages duingthe study. 

ISP with Isoflavone (low) Diet composition: E 1755kcal, protein 114g, carb 232g, fat 45g, fiber 13g:

Wangen 2001 

Age (yr):56.9 (SD) 5.8 Male%:0 Country: US Sites:mutiple BMI:25.2Soy1 N:23 Soy2 N:23 Control N:23 

Design:Xover Randomized: Yes Blinding:single Duration: 13wks

Postmenopausal women Excluded:strict vegetarian,high fiber, high soy, or low fat diets; regular vitamin and mineralsupple

mentation >RDA; 

athleticism; cigarette smoking; antibiotic or hormone use within six mo; bleeding within 1

2 mo; 

hysterectomy or oopherectomy; FSH concentration of less than 25 IU/L; history of chronicdisorders including endocrine or gynecological diseases; benign breast disease; regular use of medication known to interfere with studyendpoints (including aspirin); less than 90% or more than 1

20% ideal body

weight; weight change of more than 1

0 lb within the 

1. Soy protein powdersISP with Isoflavone (high) Diet composition:E:1783Kcal; Protein 114g,carb 233g, total fat 47.7g, SFA 15.1g, PUFA 8.1 g, MUFA 13.9g, Cholesterol 149mg 2. Soy protein powders with ISP with Isoflavone (low) Diet composition:E:1755Kcal; Protein 114g,carb 232g, total fat 45.3g, SFA 14.4g, PUFA 7.7 g, MUFA 13.3g, Cholesterol 155mg 

Soy protein powders with very low isoflavonesTotal Protein: ND Total Product: NDDiet composition: E:1799Kcal;Protein 112g, carb 243g, total fat 45.9g, SFA 14.3g, PUFA 8.1 g, MUFA 13.2g, Cholesterol 154mg 

TotalCholesterLDL:HDL Total ChoLDL HDL TriglyceriLpa Apo A1 Apo B/10T3 T4 TBG TSH Cortisol Sex HormBinding GLH FSH EstradiolEstrone Estrone SProlactin TestosterAndroste

C-65
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

previous year, and inabilityto abstain from alcololic beverages duing the study.

DHEA/DHInsulin 

Washburn 1999 

Age (yr):51 (SD 4.8) Male%:0 Country: US Sites:1 BMI: 74.3 Soy1 N:51 Soy2 N:51 Control N:51 

Design:Xover Randomized: Yes Blinding:double Duration:6wks 

Perimenopausal women aged 45-55 yr. Menopausal symptoms (at least one hot flush or night sweat daily), not on HRT (or in the past 6 mo) and currentlyperi

menopausal (missing at 

least 3 menstrual periods inthe last 1

2 mo and having 

last menstrual period not > 12 mo prior). Excluded: ND 

1. Soy.Supplement Daily

ISP with Isoflavone2. Soy.SupplementTwice.Daily ISP with IsoflavoneDiet composition:

68%

Protein, 17% carb, 3% Fat, 0% Sat Fat, 108.3 Kcal.Niacin 0 

mg, Folate

59.0 mcg.Calcium 708 mg,Potassium 203.6 mg, Sodium 203.6 mg

20 g complex carb supplement no phytoestrogens.Total Protein: <0.

02 g 

Total Product: 20gDiet composition:

94% carb, <1.0

%

Protein, <1.0% Fat, 0% Sat Fat, 83.6 Kcal. Vitamin supplement 

Total ChoLDL HDL TriglyceriSBP DBP BUN FBS MenopausymptomHot flash scoreNight swefrequencyEstrogenscore

Watanabe 2000 

Age (yr): Male%:0 Country: Japan Sites:1 BMI: Soy1 N:20 Soy2 N:20 Control N:0(?20) 

Design:Unclear Xover Randomized: Unclear Blinding:ND Duration:1 mo 

Female students in the nutritional course (premenopausal) who provideddata for at least 2 menstruation cycles beforethe experi

ment 

Excluded:ND 

Soy Isoflavones (without protein) 40mg from Soyahypocotyl tea Diet composition: ND. Soy Isoflavones (without protein) 20mg from Soyahypocotyl tea Diet composition: ND. 

No non isoflavone control arm Total Cho

LDL HDL TriglyceriBP (not sSBP or Dleucine aminopeptotal biliruMenstrualength 17-b estraProgeste

Wong 1998 9848504_Hyper 

Age (yr):41.4 (SD 7.8) Male%:100 Country: US Sites:1 

Design:Xover Randomized: Yes Blinding:N

o

Duration:5wks 

Hypercholesterolemic(Total Cholesterol>6.21,Triglyceride<5.65, LDL>4.53) men. HDL>0.91mmol/L. Age 20-50 yExcluded:Hypertensive or cholesterol-l

owering 

medication, on special diet, 

Soy protein diet NCEP Step I. Supro isolated soy protein (Protein Technologies Internati

onal, St Louis). 

Usual energySupro Diet composition:

20%

Animal protein dietProtein≥75% of each diet 

Product:ND Diet composition: 20% protein, 30%fat, 50% carb 

Total ChoLDL HDL TriglyceriApo A1 Apo B/10LDL:HDL 

C-66
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

BMI:87.1 Soy1 N:13 Control N:13 

chromic condition including GI problems and DM. 

protein, 30% fat, 50% carb 

Wong 1998 9848504_Normo 

Age (yr):35.5 (SD 7.2) Male%:100 Country: US Sites:1 BMI:87.6 Soy1 N:13 Control N:13 

Design:Xover Randomized: Yes Blinding:N

o

Duration:5 wks 

Normocholesterolemic(Total Cholesterol 3.10-4.91mmol/L, Triglyceride <1.69,LDL<3.49). HDL>0.91mmol/L. Age 20-50 yExcluded:Hypertensive or cholesterol-l

owering 

medication, on special diet, chromic condition including GI problems and DM. 

Soy protein diet NCEP Step I. Supro isolated soy protein (Protein Technologies Internati

onal, St Louis). 

Usual energySupro Diet composition:

20%

protein, 30% fat, 50% carb 

Animal protein dietProtein≥75% of each diet 

Product:ND Diet composition: 20% protein, 30%fat, 50% carb 

Total ChoLDL HDL TriglyceriApo A1 Apo B/10LDL:HDL 

Wu 2000 

Age (yr):34.1 (SD 7.4) Male%:0 Country: US Sites:1 BMI:23.1 Soy1 N:20 Control N:0 

Design:NRNCT2 Randomized: No CohortMult Blinding:N

o

Duration:3 mo 

PremenopausalExcluded:Current or recentpregnancy or lactation,irregular menstrual cycles, oral or hormonalcontraceptives or hormones, h/o chronicillness or cancer, smoker, special diets

Soy diet Tofu SoyMilksoybean peas3 cycle intervention of usualdiets supplemented with 3 traditional Asian soy foods(tofu, soymilk, Diet composition: 16.7%protein, 33.0% fat, 51

%

carb, 236 mg cholesterol 

No control arm

Menstrua

length Sex HormBinding GEstradiolProgeste

Xu 2000 

Age (yr):56.9 (SD 5.8) Male%:0 Country: US Sites:1 BMI:25.2 Total enrol:23 

Design:Xover Randomized: Yes Blinding:single Duration:93 days 

Postmenopausal women Excluded:Athleticism, strictvegetarian, high fiber orhigh soy or l

ow fat diet, 

cigarette smoking, regular vitamin/mineral supple

mentation > RDA, 

meds incl aspirin, hormones or antibioticspreceding 6 

mo, menses

preceding 12 mo,

1. Habitual dietssupple

mented with soy

protein powdersISP with Isoflavone (high) 2. Habitual dietssupple

mented with soy

protein powdersISP with Isoflavone (Low) Diet composition: 1779kcal, 113g protein, 236 g carb, 46 g fat, 13g dietary fiber 

Habitual diets supplemented withsoy protein powdersISP with Isoflavone (Lowest) Diet composition: Total Protein: 63g Total Product:ND Diet composition: 1779kcal, 113gprotein, 236 g carb, 46 g fat, 13g dietary fiber 

Urinary 2Urinary 1Equol 

C-67
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Soy1 N:18 Soy2 N:18 Control N:18 

hysterectomy, andoophorectomy

Yamaguchi 2001 

Age (yr):17-58 yr Male%:50 Country: Japan Sites:1 BMI:ND Soy1 N:12 Control N:0 

Design:NRNCT Randomized: No CohortSing Blinding:NoDuration:60 days 

adult volunteers with noabnormal liver or kidneyfunctionExcluded:intake of foodsabundant in Vitamin K 

nijiru nijiru powder (byproduct of natto which is fermented soybeans) Diet composition:ND 

No control Total Cho

HDL TriglyceriSerum OsUrinary caBUN Albumin 

Yamashita 1998 

Age (yr):40 (SD 9) Male%:0 Country: Australia Sites:1 BMI:32.4 Soy1 N:17 Control N:19 

Design:NRNCT Randomized: No Blinding:NoDuration:16 wks 

premenopausal obesewomen; BMI >25 kg/m2,age 30-61, absence of DMane endocrine, hepatic, or renal disease or pharmacotherapy that might affect arterial functionor glucose metabolism. Excluded:ND 

plant dietplant-white meat diet--soybean was substituted for lean meat with 130g dried soybean. Soybeansoffer Soy bean Diet composition:energy1500 kcal, protein 25E, soyprotein 31% total protein, fat 22% total energy, SFA 19% fat, carb 51% total energy, 54 mg cholesterol 

lean red meat diet (5d/wk, 2 d fish or non-soy legumes)red meat Protein Product: 150 g Diet composition:energy 1500 kcal, protein 25E, fat 23% total energy, SFA 28% fat, carb 50% total energy,79 mg cholesterol

Total ChoLDL HDL TriglyceriLpa MAP Systemic compliancFBS 

Yamori2002 

Age (yr):52.7 3.3 Male%:0 Country: BrazilSites:1 BMI:59.7 Soy1 N:20 

Design:RCT Randomized: Yes Blinding:double Duration:10 wks 

healthy postmenopausalJapanese immigrants fromOkinawa living in Brazil, aged 45-59 Excluded:none mentioned 

isoflavone diet mixture of roasted soybean and sesame Soy bean Diet composition:totalprotein 1800 mg, lipids2400 mg, carb 1600 mg

roasted sesame mixture Protein:ND Product:ND Diet composition:ND 

Urine deoxypyrUrine pyrBone stiff

C-68
Appendix C. Evidence Tables 

Author, Year 

Characteristics Studydesign Eligibility criteria of the 

study population

Soy Intervention Control/Placebo Outc

Control N:20 

Yildirir 2001 

Age (yr):50.1 11.8 Male%:100 Country: TurkeySites:1 BMI:25.3 Soy1 N:20 Control N:0 

Design:NRNCT Randomized: No CohortSing Blinding:NoDuration:6 wks 

Hypercholesterolemic, nonsmoking men with normal BMI. Total Cholesterol > 230 mg/dL, LDL > 160 despitethe use of NCEP/AHA Step 1 diet for at least 6 mo. Excluded:Takingcholesterol-lowering medications. Consuming EtOH or special diets.Chronic illnesses including GI problems or DM. 

Soy.Protein.Diet 60% of animal Dietcomposition: proteins of the diet were replaced by soyprotein Soy flour, bean, bean sprouts Diet composition:1846 Kcal; Protein 68.5 g; Animalprotein 16.4 g, Plant excluding soy protein 32.2 g, Fat 52.3 g, Sat fat 11.5 g, MUFA 21.7 g, PUFA 19.4 g, carb 280 g,Cholesterol 95 mg, Fiber 5.8 g. 

Compared to before diet Protein68.2with-12.2 Product Diet composition:1844 Kcal, Protein 68.2 g, Animal protein 30.2 g, Plantprotein excluding soy 36.4 g, Fat 51.6 g, Sat fat 20.8 g, MUFA 21.3 g,PUFA 9.4 g, carb 278 g, Cholesterol160 mg, Fiber 5.6 g 

Lpa Apo A1 Apo B/10PeripheraendotheliAlso TotaCholesterLDL, TrigTotalCholesterbut no co

C-69
C-70

Appendix C. Evidence Table (Part 2) 

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

ISP with 

Isoflavone 74 

Adams 2003 

Insulin like growth factor (IGF-I) IGFBP-3 IGF-I/IGFBP-3 

1o

. ISP without 

isoflavone 76 

Outcomes tabulated 

ISP with 

Isoflavone 61 Adams 2004 PSA 1o ISP without 

isoflavone 51 

Outcomes tabulated 

Albert A 2002 Vasomotor Symptoms: Score 1o Isoflavone 146 82.73±17.14 Other SD f/up 36.33±27.71 

Soy 40* Kupperman Index: 11.4 (Range: 10.7 - 12.7) ∆∆ -1.59 

Kupperman Index: 10.9 

(Range: 10.2 - 11.8) 

Albertazzi 1998 

Vasomotor 

Symptoms: Score 

and Frequency 

1o

Control/Pl 39* Significantly improved weekly hot flash frequency in both groups (44% reduction with 

weeks, p<0.01 

ISP with 

Isoflavone 

Albertazzi 1999 51 

(Same as 

Albertazzi 1998) 

Vaginal cell 

maturation index 

Equol 

1o

casein 53 

Outcomes tabulated 

ISP w/ Isofl 24 

bAP 1 ISP w/o Isofl 24 o

Casein 21 

Data expressed in a scatterplot. Baseline values for bAP were significantly different 

had higher values than control. Treatment per se had no significant ef

ISP w/ Isofl 24 

ISP w/o Isofl 24 

Alekel 2000 

NTx 1o

Casein 21 

Data expressed in a scatterplot. Treatment per se had no significant ef

Soy diet 8 49±7 SE ∆∆ 0 

Anderson 1998 GFR 1o Control/Pl 8 49±6 

Isoflavone 15 58.32±9.17 g SD f/up 59.23±9.38 

BMC: Lumbar 1o Control/Pl 13 57.73±10.68 58.41±10.83 

Isoflavone 15 0.93±0.10 g/cm2 SD f/up 0.90±0.11 

Anderson 2002 

BMD: Femoral Neck 1o Control/Pl 13 0.89±0.14 0.88±0.15 
C-71

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Soy protein 20 0.438±0.032 SE f/up 0.412±0.032 

bAP 1o milk-based 22 0.381±0.031 0.348±0.031 

Soy protein 20 51.5±22.4 SE f/up 66.6±23.1 

E2 1o milk based 22 84.8±21.5 95.0±22.2 

Soy protein 20 93.4±16.8 SE f/up 116.9±28.1 

E2 (HRT) 1o milk based 22 122.84±28.7 158.3±48.38 

Soy protein 20 35.6±6.4 SE f/up 61.7±16.9 

Arjmandi 2003 

E2 (no HRT) 1o milk based 22 45.9±13.9 93.2±44.4 

Tofu 42 1.25±0.35 mmol/L SD 

∆F -0.08 (95% CI: -0.14, -0.02) 

HDL 1o

Control/Pl 42 x-over 

Tofu 42 3.68±0.86 mmol/L SD 

∆F 0.09 (95% CI: -0.10, 0.27) 

LDL 1o

Control/Pl 42 3.68±0.86 

Tofu 42 nd SD 

∆F +6.77 (95% CI: +2.39, +11.15) 

LDL oxidation 1o

Control/Pl 42 nd 

Tofu 42 nd mg/L SD 

∆F -7.78 (95% CI: -35.59, +20.04) 

Lp(a) 1o

Control/Pl 42 nd 

Tofu 42 5.79±0.97 mmol/L SD 

∆F -0.23 (95% CI: -0.43, -0.02) 

TC 1o

Control/Pl 42 x-over 

Tofu 42 1.96±1.33 mmol/L SD 

∆F -0.15 (95% CI: -0.31, +0.02) 

Ashton E 2000 

Tg 1o

Control/Pl 42 x-over 

Soy protein 14 46.5±12.8 mg/dL SD ∆∆ 2±8.5 

HDL 1o Control/Pl 14 45.8±12.2 

Soy protein 14 145±6.3 mg/dL SD 

∆ -6.3±9.3 LDL 1o Control/Pl 14 144.2±6.7 2.07±5.8 

Soy protein 14 201.4±45.2 mg/dL SD ∆∆ -16.2±20.1 

TC 1o Control/Pl 14 197.0±47.2 

Soy protein 14 242.5±60.0 mg/dL SD ∆∆ -13.1±12.9 

Azadbakht 2003 

Tg 1o Control/Pl 14 240.5±61.6 

Soy 66 61.1±22.1 Other SD f/up 58.4±21.2 Baird DD 1995 FSH 1o Control/Pl 25 63.4±24.5 61.6±25.8 

Bakhit R 1994 HDL 1o Soy Protein 21 1.33±0.19 mmol/L SD f/up 1.30±0.11 
C-72

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Soy Protein 21 1.30±0.18 

Casein + S 21 1.28±0.16 

Control/Pl 21 1.31±0.20 

ISP + cell 11 1.38±0.26 mmol/L SD f/up 1.30±0.13 

ISP + SCF 11 1.30±0.22 

Casein + S 11 1.31±0.20 

HDL: TC > 220 

mg/dL 

Control/Pl 11 1.38±0.23 

Soy Protein 21 4.08±0.62 mmol/L SD f/up 4.01±0.54 Soy Protein 21 4.07±0.46 

Casein + S 21 4.03±0.55 

LDL 1o

Control/Pl 21 4.21±0.70 

ISP + cell 11 4.37±0.66 mmol/L SD f/up 4.14±0.63 

ISP +SCF 11 4.09±0.56 

Casein + S 11 4.11±0.64 

LDL: TC > 220 

mg/dL 

Control/Pl 11 4.35±0.76 

Soy Protein 21 5.74±0.64 mmol/L SD f/up 5.63±0.48 Soy Protein 21 5.73±0.46 

Casein + S 21 5.70±0.48 

TC 1o

Control/Pl 21 5.84±0.65 

ISP + cell 11 6.20±0.45 mmol/L SD f/up 5.79±0.53 

ISP + SCF 11 5.72±0.54 

Casein + S 11 5.83±0.60 

TC: TC(base) > 

220 mg/dL 

Control/Pl 11 6.03±0.71 

Soy Protein 21 1.72±0.99 mmol/L SD f/up 1.48±0.51 Soy Protein 21 1.68±0.76 

Casein + S 21 1.57±0.82 

Tg 1o

Control/Pl 21 1.57±0.66 

ISP + cell 11 1.98±1.27 mmol/L SD f/up 1.43±0.51 

ISP + SCF 11 1.80±0.93 

Casein + S 11 1.74±0.89 

Tg: TC >220 

mg/dL 

Control/Pl 11 1.65±0.74 

Soy 7 1.31 f/up .857 

Balk JL 2002 Vasomotor Symptoms: per wk 1o Control/Pl 12 1.28 .50 

ISP56 23 1.34±0.27 mmol/L SD ∆∆ 0.12 

HDL 1 ISP90 21 1.38±0.32 0.1 

o

Control/Pl 22 1.38±0.31 

Baum JA; 1998 

TC 1o ISP56 23 6.57±0.85 mmol/L SD f/up 6.18±0.91 
C-73

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

ISP90 21 6.47±0.88 6.13±0.91 

Control/Pl 22 6.26±0.67 6.08±0.72 

ISP56 23 1.89±1.02 mmol/L SD f/up 1.73±0.99 

Tg 1 ISP90 21 1.74±0.75 1.74±0.96 

o

Control/Pl 22 1.75±1.11 1.76±1.28 

plasma lipid ISP w/ Isofl 9 3.9±0.6 μM SD f/up 2.9 ±0.3 

peroxides 1o Whey 9 3.0±0.4 μM SD f/up 2.8±0.3 

ISP w/ Isofl 9 Bazzoli 2002 urinary 8- hydroxyl-2-

deoxyguanosine 

and total 

antioxidant status 

1o

Whey 9 

Outcome tabulated 

BA.endo.fxn_Flow ISP w/ Isofl 24 SD f/up 76±40 

.hyp 1o Control/Pl 24 81±44 

ISP w/ Isofl 24 1.56±0.46 mmol/L SD f/up 1.53±0.33 

HDL 2o Control/Pl 24 x-over 1.60±0.39 

ISP w/ Isofl 24 4.62±0.74 mmol/L SD f/up 3.70±0.77 

LDL 2o Control/Pl 24 x-over 3.57±0.74 

ISP w/ Isofl 24 7.00±0.82 mmol/L SD f/up 6.23±0.93 

TC 2o Control/Pl 24 x-over 6.18±0.85 

ISP w/ Isofl 24 1.50±0.56 mmol/L SD f/up 2.18±0.86 

Blum A 2003 

Tg 2o Control/Pl 24 x-over 2.20±1.34 

Soy Milk 60 58±2 mg/dL SE f/up 62 

HDL 1o Control/Pl 60 x-over 57 

Soy Milk 60 157±4 mg/dL SE f/up 148 

LDL 1o Control/Pl 60 x-over 158 

Soy Milk 60 1.82±0.12 ? SE f/up 1.49±0.09 

TBARs 2o Control/Pl 60 x-over 1.91±0.11 

Soy Milk 60 241±5 mg/dL SE f/up 237 

TC 1o Control/Pl 60 x-over 241 

Soy Milk 60 136±9 mg/dL SE f/up 133 

Bricarello 2004 

Tg 1o Control/Pl 60 x-over 135 

Soy 13 10.60±1.00 Other SE f/up 20.27±9.92 Brooks J 2004 E2 1o Control/Pl 15 20.11±3.55 15.14±2.11 

Soy diet 13 Other f/up 31±0.7 Brown BD 2002 Menstrual Cycle Length 1o Control/Pl 14 29.2±0.7 

Bruce B; 2003 TSH 1o Soy 21 3.00±0.44 Other SE f/up 3.49±0.52 
C-74

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Med Isofla 76 2.6±0.31 Other SE f/up 1.5±0.29 

Burke GL 2003 High Isofl 65 3.2±0.38 1.3±0.28 

Vasomotor Symptoms: per wk 1o Control/Pl 70 3.5±0.38 0.8±0.20 

High (Soy) 9 74.1 (95% CI: 66.7, 81.4) mm Hg ∆∆ -2.6 (95% CI: (-4.2, -1.0)) High (Soy) 9 76.8 (95% CI: 69.3, 84.3) 

Low protein 9 78.1 (95% CI: 69.4, 86.9) DBP 1o

Control/Pl 9 74.6 (95% CI: 67.8, 81.5) 

High (Soy) 9 135.0 (95% CI: 120.0, 150.0) mm Hg ∆∆ -5.9 (95% CI: (-8.0, -3.8)) High (Soy) 9 133.7 (95% CI: 123.7, 143.4) 

Low protein 9 131.6 (95% CI: 121.0, 142.2) 

Burke V; 2001 

SBP 1o

Control/Pl 9 131.8 (95% CI: 122.6, 141.0) 

Cross 1 5 161(graph) mg/dL SE f/up 161±4 Cross 2 5 164 (graph) 161±3 

Calculated 10 163 (mean of 1 and 2) 161 (mean of 1&2

Carroll 1978 TC 1o

Control/Pl (5, (175, 166) 170±(5, 3) 

Soy diet 6 SD f/up 362.5±82.0 E2 1o Control/Pl 6* 246.2±38.4 Soy diet 6 Other SD f/up 7.8±4.6 Cassidy 1994 FSH 1o Control/Pl 6* 14.6±5.6 

45 mg conj 6 7.2±0.9 

Isoflavone 5 4.6±0.6 

23 mg conj 6 4.2±0.1 

Control/Pl 6 8.7±0.8 

Cassidy 1995 FSH 1o

Control/Pl 5 4.6±0.2 
C-75

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Isoflavone 6 81.7 -11

Cassidy 1995 E2 1o

Isoflavone 5 114.4 -30

40 mg Isof 57 g/cm2 SD ∆ -0.47±2.14 

80mg Isofl 50 0.14±2.19 BMD: Femoral Neck 1o Control/Pl 53 0.04±2.86 

40 mg Isof 57 g/cm2 SD ∆ -0.48±1.81 

BMD: Hip 1 80mg Isofl 50 -0.21±1.62 o

Control/Pl 53 -0.51±1.82 

40 mg Isof 57 g/cm2 SD ∆ -0.47±2.60 

80mg Isofl 50 -0.89±1.88 

Chen YM; 2003, 

2004 

BMD: Lumbar 1o

Control/Pl 53 -0.63±2.56 

Diet group 24 81.3±8.7 mm Hg SD ∆ 0.2 (95% CI: -5.3/5.76) 

HRT 41 80.2±8.2 -1.07 (95% CI: -4.45/2.3) DBP 

Control/Pl 43 81.4±9.0 2.8 (95% CI: -1.51/7.23

Diet group 24 52.01±11.6 mg/dL SD ∆ -1.8 (95% CI: -4.69/0.94) 

HRT group 41 51.9±11.3 -5.5 (95% CI: -7.59/-3.45) HDL 

Control/Pl 43 54.7±11.7 -3.6 (95% CI: -5.51/-1.83) 

Diet group 24 159.3±34.5 mg/dL SD ∆ -6.1 (95% CI: -17.11/4.76) 

HRT group 41 156.8±31.7 -12.0 (95% CI: -21.67/-2.37) 

LDL 

Control/Pl 43 145.02±26.9 0.3 (95% CI: -5.39/6.1) 

Soy diet 24 29.5±31.3 SD ∆ 4.92 (95% CI: -20.1, 29.9) 

NTx 1 HRT 41 40.6±64.4 -10.1 (95% CI: -23, 2.7

o

Control/Pl 43 29.9±40.7 1.34 (95% CI: -17.6, 20.3) 

Chiechi 2002 

SBP Diet group 24 131.8±14.3 mm Hg SD ∆ -3.4 (95% CI: -11.9/5.11) 
C-76

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

HRT group 41 130±13.5 -9.7 (95% CI: -14.8/-4.71) 

Control/Pl 43 129.5±14.8 -3.1 (95% CI: -10.06/3.7) 

Soy diet 24 21.9±44.3 SD 

∆ 5.45 

HRT 41 14.5±11.3 -1.10 

Serum Osteocalcin 1o Control/Pl 43 15.5±10.5 1.7 

diet group 24 235.5±38.7 mg/dL SD 

∆ -8.6 (95% CI: -20.98/3.65) 

HRT group 41 233.8±36.5 -15.1 (95% CI: -23.37/-6.94) TC 

Control/Pl 43 220.08±31.5 -2.6 (95% CI: -8.65/3.35) 

Diet group 24 119.7±65.4 mg/dL SD 

∆ -3.3 (95% CI: -22.7/15.4) 

HRT group 41 124.6±56.1 -7.02 (95% CI: -20.64/6.59) 

Tg 

Control/Pl 43 99.5±49.8 3.6 (95% CI: -3.31/10.6

Chiechi 2002 

12191852 

Soy diet 22 10.1±18.8 Other SD f/up 6.2±18.8 E2 1o Control/Pl 41 13.6±16.3 15.7±22.6 Soy diet 22 60.9±21.6 Other SD f/up 61.8±18.8 Chiechi 2003 FSH 1o Control/Pl 41 59.1±27.6 58.4±26.1 

Genistein 30* 4.6±0.58 no unit SE error Crisafulli 2004 Vasomotor Symptoms: Score 1o Control/Pl 30* 4.7±0.58 

3mg Isofla 16 1.24±0.31 mmol/L SD f/up 1.24±0.31 27mg Isofl 12 1.14±0.34 1.14±0.28 37mg Isofl 18 1.09±0.18 1.19±0.18 62mg Isofl 15 1.22±0.26 1.27±0.28 

HDL: LDL 

140-166 mg/dL 1o

Control/Pl 15 1.06±0.21 1.06±0.21 

3 mg Isofl 28 1.19±0.28 mmol/L SD f/up 1.19±0.28 

27 mg Isof 27 1.16±0.26 1.16±0.23 37 mg Isof 30 1.16±0.23 1.19±0.21 62 mg Isof 30 1.19±0.23 1.22±0.28 

Crouse J 1999 

HDL: LDL 

140-200 mg/dL 1o 

Control/Pl 31 1.16±0.23 1.14±0.23 
C-77

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

3mg Isofla 12 1.16±0.23 mmol/L SD f/up 1.11±0.18 27mg Isofl 15 1.16±0.18 1.22±0.21 37mg Isofl 12 1.24±0.18 1.19±0.28 62mg Isofl 15 1.19±0.21 1.16±0.26 

HDL: LDL 

166-200 mg/dL 1o

Control/Pl 16 1.24±0.23 1.19±0.23 

3mg Isofla 16 3.83±0.23 mmol/L SD f/up 3.85±0.52 27mg Isofl 12 3.88±0.23 3.98±0.57 37mg Isofl 18 3.77±0.23 3.88±0.36 62mg Isofl 15 3.80±0.23 3.83±0.31 

LDL: : LDL 

140-166 mg/dL 1o

Control/Pl 15 3.77±0.21 3.85±0.41 

3 mg Isofl 28 4.24±0.59 mmol/L SD f/up 4.14±0.57 

27 mg Isof 27 4.40±0.62 4.27±0.65 37 mg Isof 30 4.16±0.59 4.03±0.49 62 mg Isof 30 4.29±0.65 4.03±0.44 

LDL: LDL 140-200 

mg/dL 

Control/Pl 31 4.27±0.54 4.27±0.59 

3 mg Isofl 12 4.78±0.47 mmol/L SD f/up 4.53±0.44 

27 mg Isof 15 4.81±0.52 4.50±0.62 37 mg Isof 12 4.71±0.49 4.27±0.57 62 mg Isof 15 4.78±0.54 4.22±0.47 

LDL: LDL 166-200 

mg/dL 1o

Control/Pl 16 4.71±0.31 4.65±0.47 

3mg Isofla 16 5.77±0.44 mmol/L SD f/up 5.79±0.52 27mg Isofl 12 5.92±0.49 5.87±0.67 37mg Isofl 18 5.66±0.49 5.82±0.44 62mg Isofl 15 5.84±0.39 5.95±0.47 

TC: LDL 140-166 

mg/dL 1o

Control/Pl 15 5.72±0.31 5.74±0.52 

3 mg Isofl 28 6.18±0.70 mmol/L SD f/up 6.10±0.65 

27 mg Isof 27 6.41±0.75 6.21±0.78 37 mg Isof 30 6.08±0.70 5.97±0.57 

TC: LDL 140-200 

mg/dL 

1o

62 mg Isof 30 6.28±0.67 6.03±0.52 
C-78

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

 Control/Pl 31 6.21±0.62 6.23±0.70 

3 mg Isofl 12 6.75±0.57 mmol/L SD f/up 6.52±0.54 

27mg Isofl 15 6.83±0.70 6.47±0.80 

37 mg Isof 12 6.72±0.41 6.21±0.65 62 mg Isof 15 6.75±0.59 6.13±0.54 

TC: LDL 166-200 

mg/dL 1o

Control/Pl 16 6.67±0.41 6.67±0.54 

3mg Isofla 16 1.54±0.72 g/L = mg/mL SD f/up 1.56±0.64 27mg Isofl 12 1.93±0.56 1.85±0.80 37mg Isofl 18 1.70±0.68 1.63±0.63 62mg Isofl 15 1.82±0.59 1.87±0.81 

Tg: LDL 140-166 

mg/dL 1o

Control/Pl 16 1.87±0.78 1.84±0.76 

3 mg Isofl 28 1.63±0.68 g/L = mg/mL SD f/up 1.72±0.65 

27 mg Isof 27 1.87±0.71 1.74±0.79 37 mg Isof 30 1.69±0.62 1.64±0.63 62 mg Isof 30 1.73±0.67 1.72±0.75 

Tg: LDL 140-200 

mg/dL 1o

Control/Pl 31 1.73±0.70 1.89±0.84 

3 mg Isofl 12 1.76±0.63 g/L = mg/mL SD f/up 1.93±0.64 

27 mg Isof 15 1.83±0.81 1.65±0.80 

37mg Isofl 12 1.66±0.54 1.64±0.67 62mg Isofl 15 1.65±0.75 1.57±0.65 

Tg: LDL 166-200 

mg/dL 1o

Control/Pl 16 1.59±0.60 1.93±0.91 

Soy protein ND 73±2 mm Hg SE f/up 70±3 

DBP Control/Pl ND 73±2 69±3 

Soy protein 18 5.3±1.2 % SE f/up 9.4±1.8 

Cuevas A 2003 

FMD (RH) Control/Pl 18 5.3±1.2 4.9±1.5 
C-79

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Soy protein 18 56.5±5.8 Other SE f/up 58.6±6.6 

FSH Control/Pl 18 56.5±5.8 60.4±6.3 

Soy protein ND 53.8±2.5 mg/dL SE f/up 53±1.9 

HDL Control/Pl ND 53.8±2.5 50.8±1.9 

Soy protein ND 194.8±6.0 mg/dL SE f/up 160±6.8 

LDL 1o Control/Pl ND 194.8±6.0 160.8±8.0 

Soy protein ND 132±4 mm Hg SE f/up 127±5 

SBP Control/Pl ND 132±4 127±5 

Soy protein 18 285.9±6.8 mg/dL SE f/up 240.5±7.5 

TC Control/Pl 18 285.9±6.8 243.7±9.6 

Soy protein ND 190.3±18.7 mg/dL SE ∆ -54.7 

Tg Control/Pl ND 190.3±18.7 -30.1 

DBP 2o Soy diet 20 87±8 mm Hg SD f/up 87±10 

D'Amico 1992 SBP 2o Soy diet 20 143±20 mm Hg SD f/up 141±21 

Soy bread 

Dalais 1998 Vasomotor symptoms 1o Wheat bread 44 No statistically significant decrease in hot flush rate was detected during soy ingestio

Women consuming soy showed a statistically significant increase of 103% in vagina

compared to baseline (p=0.03) 

ISP w/ Isofla 37 15.29 ∆ -0.8 

D-pyr 1o Wheat protein 40 14.47 nmol/umol creatinine -0.3 

ISP w/ Isofla 37 7.07 ∆ -0.38 

Dalais 2003 Pyr 1o Wheat protein 40 7.35 nmol/umol creatinine -0.08 

Soy isoflavone Davis 2001 NF-kB 5-OhmdU 1o No control Outcomes tabulated 

SPI+ 24 1.51 mmol/L f/up 1.39 

HDL SPI- 24 1.45 1.42 

Control/Pl 21 1.48 1.42 

SPI+ 24 3.28 mmol/L SE f/up 3.43 

LDL SPI- 24 3.49 3.51 

Control/Pl 21 3.47 3.51 

SPI+ 24 18.75 nmol/L f/up 18.75 

Lp(a) SPI- 24 18.75 18.75 

Control/Pl 21 26.25 48.75 

SPI+ 24 5.42 mmol/L SE f/up 5.42 

SPI- 24 5.63 5.48 

Dent SB 2001 

TC 

Control/Pl 21 5.49 5.48 
C-80

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

SPI+ 24 1.062 mmol/L 

Uncl

ear 

SD/

SE 

f/up 1.186 

SPI- 24 1.124 1.062 

Tg 

Control/Pl 21 0.812 1.31 

Isoflavone 20 1.2±0.1 mmol/L SE f/up 1.0±0.1 

HDL 1o Control/Pl 16 1.2±0.1 1.0±0.1 

Isoflavone 18 6.8±0.2 mmol/L SE f/up 6.4±0.2 

TC 1o Control/Pl 16 6.3±0.5 6.0±0.2 

Isoflavone 17 0.8±0.1 mmol/L SE f/up 0.9±0.1 

Dewell A 2002 

Tg 1o Control/Pl 16 1.3±0.2 1.4±0.2 

Djuric 2001 5-OHmdU levels 1o SPI+ 12 Outcomes tabulated 

low Isofla 18 35.6±3.1 SE f/up 34.7±2.4 

E2 1o high Isofl 18 35.6±3.1 29.7±2.3 

low Isofla 18 56.2±1.13 SE f/up 52.6±0.70 

low-Isofla 14 4.24±0.8 

high Isofl 18 56.2±1.13 54.2±0.67 

high-Isofl 14 4.15±0.8 

FSH 1o

Control/Pl 18 56.2±1.13 52.6±0.67 

low Isofla 18 0.94±0.04 nmol/L SE f/up 0.90±0.02 

Testosterone 1o high-Isofl 18 0.94±0.04 0.83±0.02 

low Isofla 18 3.48±0.15 SE f/up 3.33±0.14 low Isofla 14 1.52±0.3 

high Isofl 18 3.48±0.15 3.49±0.13 high Isofl 14 1.41±0.3 

Control/Pl 18 3.48±0.15 3.25±0.13 

Duncan A 1999 

TSH 1o

Control/Pl 14 1.44±0.3 

Duffy 2003 Cognitive function 1o Isoflavones 18 Soy isoflavones group showed significantly greater improvement in delay recall of p
C-81

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

 tests Lactose 15 tests, and in PASAT. Groups did not differ in any other cognitive function tests. 

Isoflavone 38 10.1±6.4 SE ∆ -6.4±1.0 Faure ED 2002 Vasomotor Symptoms: per wk 1o Control/Pl 35 9.4±3.4 -2.2±1.2 

High soya 

File 2001 Memory Tests 1o

Low soya 

27 

High soy diet showed significant improvements in short-term (immediate recall of pro

sample of patterns) and long-term memory (picture recall after 20 min) and in menreversal). In a letter fluency test and in a test of planning (Stockings of Cambridgeperformance only in females. 

There was no effect of diet on tests of attention or in a category generation task. 

E2 1o Soy 16 32.30±11.69 Other SD f/up 27.40±13.23 Foth D;N 2003 FSH 1o Soy 16 70.94±39.23 Other SD f/up 72.47±30.38 

SPI 96 17 55.0±3.1 mg/L SE f/up 52.9±3.5 

HDL 2 SPI 52 19 56.9±3.0 51.7±2.6 

o

SPI 4 14 55.8±2.8 51.9±2.2 

SPI 96 17 137.9±7.6 mg/dL SE f/up 140.9±7.1 

LDL 2 SPI 52 19 135.5±7.4 138.2±6.7 

o

SPI 4 14 134.5±13.5 133.8±13.8 

SPI 96 17 220.6±8.3 mg/dL SE f/up 223.3±7.5 SPI 52 19 219.5±7.7 (per author by email) TC 2 218.3±6.9 

o

SPI 4 14 212.5±13.6 212.4±14.5 

SPI 96 17 137.7±19.5 mg/dL SE f/up 147.3±14.7 SPI 52 19 135.3±16.4 141.7±14.6 

Gallagher 2004 

Tg 2o

SPI 4 14 109.9±11 133.4±15.6 

Soy-Isofla 33 1.4±0.3 mmol/L SD f/up 1.5±0.2 

HDL 1 Soy+Isofla 31 1.5±0.3 1.6±0.3 

o

Control/Pl 30 1.5±0.4 1.5±0.4 

Soy-Isofla 33 3.9±0.6 mmol/L SD ∆ -0.09 

LDL 1 Soy+Isofla 31 3.9±0.6 -0.38 

o

Control/Pl 30 4.0±0.5 ND 

Soy-Isofla 33 5.9±0.7 mmol/L SD ∆ -0.02 

TC 1 Soy+Isofla 31 5.9±0.6 -0.27 

o

Control/Pl 30 6.1±0.6 ND 

Soy-Isofla 33 1.3±0.5 mmol/L SD f/up 1.3±0.6 

Soy+Isofla 31 1.3±0.8 1.3±0.7 

Gardner 2001 

Tg 1o

Control/Pl 30 1.3±0.7 1.4±1.0 

Gardner-Thorpe 

2003 E2 1o Soya flour 19 102.80 (95% CI: 93.07-113.55) SD ∆F 0.05 (95% CI: -1.07, 1.16) 
C-82

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Soya flour 19 1.00 (IQR: 0.90-1.18) mmol/L SD 

∆F 0.00 (IQR: -0.10,0.00) 

HDL 1o Control/Pl ND* 

Soya flour 19 3.60 (IQR: 3.30-4.70) mmol/L SD 

∆F 0.15 (IQR: -0.15,0.40) 

LDL 1o Control/Pl ND* 

Soya flour 19 5.5 (IQR: 4.70-6.83) mmol/L SD 

∆F 0.00 (IQR: -0.15,0.35) 

TC 1o Control/Pl ND 

Testosterone 1o Soya flour 19 19.30 (95% CI: 16.98-21.93) nmol/L SD 

∆F 1.06 (95% CI: 1.01, 1.12) 

Soya flour 19 1.20 (IQR: 1.00-2.90) mmol/L SD 

∆F 0.00 (IQR: -0.30,0.45) 

Tg 1o Control/Pl ND* 

Hydroperoxides Soya flour 19 μmol /L 

∆F% -13% 

1o Control/Pl ND* 2.69 -4% 

Soya flour 19 min 

∆F% +2% 

Lag time 1o Control/Pl ND* 59 +2% 

DBP 2o Soy diet 20 89.2±1.9 mm Hg SE f/up 87.4±2.2 

Gentile 1993 SBP 2o Soy diet 20 141.1±4.8 mm Hg SE f/up 142.4±4.6 

Soy diet 12 45±10 mg/dL SD f/up 44±11 

HDL 1o Control/Pl 12 same 45±10 

Soy diet 12 191±19 mg/dL SD f/up 158±27 

LDL 1o Control/Pl 12 same 168±21 

Soy diet 12 260±23 mg/dL SD f/up 220±21 

TC 1o Control/Pl 12 same 228±21 

Soy diet 12 116±45 mg/dL SD f/up 104±34 

Goldberg 1982 

Tg 1o Control/Pl 12 Same 103±39 

Soy diet 42 

∆F 0.1 (-0.6, 0.8) 

Estradiol 1o Lean meat diet 42 

Soy diet 42 

∆F 4.6 (-3.0,12.2) 

Habito 2000 Testosterone 1o Lean meat diet 42 

Soy flour 1.8 mIU/L f/up -0.6 ISP w/Isoflavones + cotyledon 1.8 mIU/L f/up -0.6 ISP w/Isoflavones + cellulose 1.8 mIU/L f/up -0.7 

Ham 1993 TSH 1o

Casein+cellulose 

17 

1.8 mIU/L f/up -0.3 

Isoflavone 40 84±1 SE f/up 85±1 

DBP 1o Placebo 40 84±2 84±1 

Han KK 2002 

E2 1o Isoflavone 40 9±1.2 SE f/up 19±2.2 
C-83

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

 Placebo 40 9.6±0.5 10.9±0.6 

Fasting Blood Isoflavone 40 95.6±1.5 SE f/up 97.4±1.4 

Glucose 1o Placebo 40 96.8±1.7 93.9±1.4 

Isoflavone 40 90.3±3.3 SE f/up 67±3.2 

FSH 1o Placebo 40 84.3±0.5 65.4±3.7 

Isoflavone 40 40.2±1.4 mg/dL SE f/up 44.3±1.6 

HDL 1o Placebo 40 40±1.3 43.9±1.6 

Isoflavone 40 133.6±5.3 mg/dL SE f/up 120.3±4.3 

LDL 1o Placebo 40 133.5±6.4 139±5.2 

Isoflavone 40 131±2 f/up 131±1 

SBP 1o Placebo 40 133±3 133±2 

Isoflavone 40 225.6±6.2 mg/dL SE f/up 199±5 

TC 1o Placebo 40 226.6±7.7 226.8±8.1 

Isoflavone 40 204.3±23.3 mg/dL SE f/up 210.8±15.8 

Tg 1o Placebo 40 175.8±23.3 186.1±6.2 

ISP w/Isoflav 28 

Hargreaves 2005 

Breast cell 

epithelial 

proliferation 

1o

Control 56 

Outcomes tablulated 

Soy 20 78±5 mm Hg SD f/up 77±7 

DBP 1o Control/Pl 20 78±6 77±6 

Soy 20 1.31±0.22 mmol/L SD ∆∆ 0% 

HDL 1o Control/Pl 20 1.28±0.29 

Soy 20 11.2±3.9 mmol/L SD ∆∆ -14% 

Homocysteine 1o Control/Pl 20 10.6±2.6 

Soy 20 3.63±0.78 mmol/L SD ∆∆ -10% 

LDL 1o Control/Pl 20 3.64±0.80 

Soy 20 29.5±29.9 SD ∆∆ +8% 

Lp(a) 1o Control/Pl 20 32.3±37.5 

Soy 20 130±9 SD f/up 130±10 

SBP 1o Control/Pl 20 130±9 129±10 

Soy 20 5.68±0.84 mmol/L SD f/up 5.11±0.78 

TC 1 

o

Control/Pl 20 5.59±0.81 5.45±0.88 

Soy 20 1.70±1.17 mmol/L SD ∆∆ -22% 

Hermansen 

2001 

Tg 1o Control/Pl 20 1.70±1.49 

ISP 9* ~5.2 SE error Hill S 2004 Lipid Peroxides 1o Control/Pl 9* ~4.8 
C-84

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Hsu CS;S 2001 E2 1o Isoflavone 37 9.6±7.7 SD f/up 21.4±22.6 

Soy 5* ND mg/dL SE f/up 76±8 

Huff MW; 1984 Fasting Blood Glucose 2o Control/Pl 5* ND f/up 86±10 

Soy 29 81.5±8.78 mm Hg SD 

∆ -0.41%±10.4% 

DBP 1o Control/Pl 29 82.6±7.8 -0.23%±8.83% 

Soy 32 48.7±18.7 SD 

∆ -5.23%±16.8% 

FSH 2o Control/Pl 32 49.2±18.6 -2.29%±13.1% 

Soy 31 1.32±0.33 mmol/L SD 

∆ +0.69%±10.1% 

HDL 1o Control/Pl 31 1.30±0.30 +1.29%±8.78% 

Soy 31 3.63±0.91 mmol/L SD 

∆ -7.09%±12.7% 

LDL 1o Control/Pl 31 3.47±1.06 +5.35%±15.2% 

Soy 29 146.9±18.8 SD 

∆ -0.76%±9.63% 

SBP 1o Control/Pl 29 147.2±15.2 +1.65%±7.46% 

Soy 31 5.78±1.02 mmol/L SD 

∆ -4.07%±8.13% 

TC 1o Control/Pl 31 5.62±1.05 +2.82%±8.70% 

Soy 32 2.15±1.08 SD 

∆ +9.23%±36.4% 

Jayagopal 2002 

TSH 2o Control/Pl 32 2.18±1.08 +9.48%±46.1% 

Soy 31 79±2 mm Hg SE ∆∆ 2.1%±1.9% 

DBP 1o Control/Pl 31 80±2 

Soy 31 1.26±0.06 mmol/L SE ∆∆ -0.2%±1.6% 

HDL 1o Control/Pl 31 1.24±0.06 

Soy 31 4.40±0.15 mmol/L SE ∆∆ -6.7%±1.7% 

LDL 1o Control/Pl 31 4.37±0.15 

Soy 31 31.8±4.7 mg/L SE ∆∆ 7.2%±5.2% 

Lp(a) 1o Control/Pl 31 28.8±4.2 

Soy 31 120±3 mm Hg SE ∆∆ 1.3%±2.2% 

SBP 1o Control/Pl 31 120±3 

Soy 31 6.08±0.21 ? SE ∆∆ -2.6%±3.3% 

TBARS 1o Control/Pl 31 6.35±0.17 

Soy 31 6.48±0.16 mmol/L SE ∆∆ -6.2%±1.2% 

TC 1o Control/Pl 31 6.42±0.17 

Soy 31 1.79±0.13 mmol/L SE ∆∆ -8.3%±4.4% 

Jenkins 1999 

Tg 1o Control/Pl 31 1.78±0.14 

Conjugated Soy 31 67 pmol/L ∆∆% -16% 

dienes 1o Control/Pl 31 62 +2% Jenkins 1999 Jenkins 2000 (2 

publications that 

include patients Conjugated 1o Soy 31 15.7 μmol/mm ol ∆∆% -4% 
C-85

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

dienes:LDL Control/Pl 31 14.6 +8% 

Soy 20 μmol/mm ol ∆∆% 12.9 

from Jenkins 

1999 paper) Conjugated 

dienes:LDL 1o Control/Pl 20 14

low Isoflav 41 78±1 mm Hg SE f/up 76±1 

DBP 1 high Isoflav 41 78±2 77±1 o

Control/Pl 41 78±2 78±1 

low Isoflav 41 1.32±0.05 mmol/L SE f/up 1.27±0.05 

HDL 1 high Isoflav 41 1.32±0.06 1.25±0.05 o

Control/Pl 41 1.33±0.05 1.23±0.05 

low Isoflav 41 8.2±0.3 mcmol/L SE f/up 7.4±0.3 

Homocysteine 1 high Isoflav 41 8.2±0.4 7.6±0.4 o

Control/Pl 41 7.6±0.3 8.0±0.4 

low Isoflav 41 4.52±0.12 mmol/L SE f/up 4.18±0.11 

LDL 1 high Isoflav 41 4.55±0.11 4.14±0.11 o

Control/Pl 41 4.62±0.10 4.47±0.11 

low Isoflav 41 20.2±3.1 mg/dL SE f/up 21.7±3.4 

Lp(a) 1 high Isoflav 41 19.2±2.5 20.1±3.2 o

Control/Pl 41 19.6±3.1 21.6±3.4 

low Isoflav 41 124±3 mm Hg SE f/up 120±2 

SBP 1 high Isoflav 41 123±3 122±2 o

Control/Pl 41 125±3 123±3 

low Isoflav 41 6.68±0.13 mmol/L SE f/up 6.22±0.12 

TC 1 high Isoflav 41 6.76±0.12 6.32±0.12 o

Control/Pl 41 6.84±0.10 6.64±0.12 

low Isoflav 41 1.84±0.18 mmol/L SE f/up 1.70±0.17 

high Isoflav 41 1.96±0.17 2.04±0.23 

Jenkins 2002 

Tg 1o

Control/Pl 41 1.96±0.17 2.07±0.22 

low Isoflav 37 pmol/L f/up -16% 

high Isoflav 37 -16% 

Jenkins 2002 

Conjugated dienes 1o Control/Pl 37 +1%

Soy based diet Jenkins 2003 PSA 1o Control/Pl 46 Outcomes tabulated 

Isoflavone 69 46.3±21.2 no unit SD ∆ 9.69±9.04 

Jones G, 2003 bAP 1o Control/Pl 59 49.0±24.9 8.37±10.1 

Soycreme 15 Kanazawa 1995 Oxidized LDL 1o Control/Pl 10 Outcomes tabulated 
C-86

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

1/mo 21 54.3±16.6 

Uncl

ear 

SD/

SE 

∆ +1.9±24.4 

1/wk 16 51.9±19.0 -7.1±17.5 3/wk 18 63.8±19.8 +6.7±20.8 

bAP 1o

Control/Pl 18 60.8±21.5 -0.6±20.9 

1/mo 21 45.8±23.2 

Uncl

ear 

SD/

SE 

∆ -12.0±16.7 

1/wk 16 36.0±15.3 -11.7±19.1 3/wk 18 46.7±13.8 -2.2±30.4 

NTx 1o

Control/Pl 18 35.7±14.0 -2.7±24.4 

1/mo 21 1.42±0.99 

Uncl

ear 

SD/

SE 

∆ -0.29±0.73 

1/wk 16 1.95±1.55 +0.22±1.68 3/wk 18 1.68±1.46 +1.18±2.88 

Katsuyama 2004 

Serum 

Osteocalcin 1o

Control/Pl 18 1.91±1.03 -0.01±1.43 

ISP w/ Isofl 24 Khalil 2002 Bone biomarkers 1o Casein 22 Outcomes tabulated 

Isoflavone 9 74.7±30.9 Other SD f/up 67.4±40.7 FSH 1o Control/Pl 11 74.3±24.3 63.9±26.7 Isoflavone 9 50.2±13.6 SD f/up 29.1±42.5 Knight D 2001 Vasomotor 

Symptoms: per wk 1o Control/Pl 11 56.2±26.5 45.5±31.3 

Kotsopoulos Soy 34 0.82±0.17 SE f/up 0.77±0.17 

2000 

Vasomotor 

Symptoms: Score 1o Control/Pl 41 0.85±0.12 0.83±0.12 

Soy 88 0.861±0.112 g/cm2 SE ∆∆ 0.005 (95% CI: -0.004, 0.013) 

BMD: Hip 2o

Control/Pl 87 0.831±0.119 

Soy 88 0.917±0.15 g/cm2 SE ∆∆ -0.001 (95% CI: -0.010

0.008) 

BMD: Lumbar 1o

Control/Pl 87 0.895±0.166 

Soy 88 12.7±3.9 SE ∆∆ -0.229 (95% CI: -0.983

0.525) 

Kreijkamp-Kaspe

rs 2004 

bAP 2o

Control/Pl 87 12.9±4.0 
C-87

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Soy 88 59.08±15.8 mg/dL SE ∆∆ +1.93 (95% CI: -0.39, 3.86) 

HDL 2o

Control/Pl 87 59.0±13.14 

Soy 88 161±38.2 mg/dL SE ∆∆ +5.40 (95% CI: -1.54, 12.74) 

LDL 2o

Control/Pl 87 159.4±33.9 

Soy 88 0.27±0.37 g/L = mg/mL SE ∆∆ 0.03 (95% CI: -0.01, 0.06) 

Lp(a) 2o

Control/Pl 87 0.24±0.27 

Soy 88 240.15±45.1 mg/dL SD ∆∆ +5.79 (95% CI: -2.3, 13.9) 

TC 1o

Control/Pl 87 236.2±36.6 

1o Soy 88 120.3±63.7 mg/dL SE ∆∆ -7.96 (95% CI: -19.5, 2.65) 

Tg 

 Control/Pl 87 110.6±52.2 

FMD Soy 75 4.8 % f/up +0.3 

(RH) 1o Control/Pl 78 4.4 0 

ISP w/isoflav 88 138.4±16.7 mm Hg 139.2±18.2 

SBP 1o Milk protein 87 143.4±18.2 mm Hg ∆∆ 139.9±18.1 

ISP w/isoflav 88 74.1±10.7 mm Hg 74.4±14.1 

KreijkampKasper

s 2005 

DBP 1o Milk protein 87 76.2±12.9 mm Hg 

SD 

∆∆ 74.5±12.4 

Isoflavones 27 Kritz-Silverstein, 

2003 Cognitive function 1o Placebo 26 

Performance in category fluency in the soy isoflavones group improved by 23% betw

whereas the performance in the placebo group improved only by 3% (P=0.02) 

No significant differences in any other cognitive function tests between the groups. 

Soy protein 33 1.31±0.21 SE f/up 1.28±0.19 

Kumar NB 2002 E2 1o Control/Pl 33 1.54±0.18 1.59±0.25 

milk 34 77±10 mm Hg SD f/up 73±10 

DBP 1o Soybean 34 77±10 77±8 

milk 34 1.31±0.32 mmol/L SD f/up 1.30±0.41 

HDL 1 milk/Soy o 34 1.31±0.32 1.37±0.38 o

Soybean 34 1.31±0.32 1.40±0.28 

milk 34 4.45±0.95 mmol/L SD f/up 4.36±1.07 

LDL 1 milk/Soy o 34 4.45±0.95 4.29±1.15 o

Soybean 34 4.45±0.95 4.26±1.04 

milk 34 131±17 mm Hg SD f/up 123±15 

SBP 1o Soybean 34 131±17 128±15 

milk 34 1.35±0.43 ? SD f/up 1.26±0.43 

Kurowska 1997 

TBARs 1o Soybean 34 1.35±0.43 1.41±0.55 
C-88

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

milk 34 6.86±0.99 mmol/L SD 

∆F -1% 

TC 1 milk/Soy 34 6.86±0.99 4% o

Soybean 34 6.86±0.99 9% 

milk 34 1.75±0.64 mmol/L SD f/up 1.85±0.72 

Tg 1 milk/Soybean 34 1.75±0.64 1.90±0.85 o

Soybean 34 1.75±0.64 1.94±0.83 

soy protein 

supplement 6 Laskowski 2003 Adaptation 

process 1o no soy protein 

supplement 6 

Outcomes tabulated 

ISP+ 8 Lenn 2002 Cortisol 1o Control/Pl 7 Outcomes tabulated 

Soy w/o Isoflav 42 1.32±0.28 mmol/L SD f/up 1.36±0.34 

Soy w/ Isoflav 42 1.32±0.28 1.36±0.33 

animal die 42 1.32±0.28 1.33±0.32 HDL 

animal die 42 1.32±0.28 1.31±0.34 

Soy w/o Isoflav 42 4.14±0.65 mmol/L SD f/up 4.34±0.92 

Soy w/ Isoflav 42 4.14±0.65 4.29±0.96 

animal wit 42 4.14±0.65 4.42±0.97 LDL 1o

animal WIT 42 4.14±0.65 4.44±1.01 

Soy w/o Isoflav 42 6.17±0.78 mmol/L SD f/up 6.37±1.12 

Soy w/ Isoflav 42 6.17±0.78 6.24±1.11 

animal wit 42 6.17±0.78 6.47±1.17 TC 1o

animal WIT 42 6.17±0.78 6.42±1.17 

Soy w/o Isoflav 42 1.54±0.66 mmol/L SD f/up 1.27±0.50 

Soy w/ Isoflav 42 1.54±0.66 1.27±0.46 

animal die 42 1.54±0.66 1.44±0.57 

Lichtenstein 

2002 

Tg 1o

animal die 42 1.54±0.66 1.46±0.52 

Isoflavones 20* 163±29 mg/dL SE 

∆ -0.56%±2.5% 

LDL 1o Control/Pl 20* 165±22 -5.6%±2.5% 

Isoflavones 20* 243±26 mg/dL SE 

∆ -2.2%±1.7% 

TC 1o Control/Pl 20* 236±22 -5.2%±2.0% 

Isoflavones 20* 1.3 % 

∆ +3.4 

Lissin L 2004 

FMD 

(RH) 1o Control/Pl 20* 3.8 -0.6 

Lu 1996 Menstrual Cycle Length 1o Soy milk 6 28.3 days 

∆ +3.5 

Lu LJ;An 2000 Menstrual Cycle Length 1o Soy milk 10 26.6±1.6 days SD f/up 26.0±2.0 
C-89

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Soymilk w/ 9 2.7 IU/L ∆ -0.2 

FSH 1o Soymilk w/ 

Soymilk w/ 9 107 pg/mL ∆ 0 

Lu LJ 2001 estradiol 1o Soymilk w/ 

Soymilk w/ 8 Other SD f/up 26.6±2.9 Luz LJW; 2000 Menstrual Cycle Length 2o Soymilk no 8 25.8±1.9 

BMD: Femoral Soymilk w/ 23 ND g/cm2 SD ∆ -0.9 

Neck 1o Soymilk w/ 22 ND +0.2 

Soymilk w/ 23 0.925±0.260 g/cm2 SD ∆ +1.1% 

Lydeking-Olsen 

2004 BMD: Lumbar 1o Soymilk w/ 22 0.865±0.190 -4.2% 

ISP+ 25 1.52±0.39 mmol/L SD f/up 1.52±0.31 

HDL 1 ISP- 24 1.66±0.45 1.70±0.45 o

? tot 1.59±0.42 1.60±0.39 

ISP+ 25 5.07±0.73 mmol/L SD f/up 4.71±0.73 

LDL 1 ISP- 24 5.11±1.02 4.78±0.96 o

? tot 5.09±0.88 4.74±0.84 

ISP+ 22 43.73±22.89 SD f/up 38.85±20.19 

SHBG_outcomes 1 ISP- 24 45.03±17.79 43.07±19.18 o

? tot 44.41±20.17 41.05±19.57 

ISP+ 25 7.29±0.90 mmol/L SD f/up 6.94±0.84 

TC 1 ISP- 24 7.47±1.04 7.15±1.02 o

? Tot 7.38±0.96 7.04±0.93 

ISP+ 25 1.53±0.82 mmol/L SD f/up 1.54±0.74 

ISP- 24 1.54±0.72 1.46±0.82 

Mackey R 2000 

Tg 1o

? tot 1.53±0.77 1.50±0.77 

Testosterone 

FSH 

Mackey 2000 

11216493_study

2 TSH 

1o ISP+ 27 Outcomes tabulated 

Martini 1999 E2 1o ISP+ 36 Outcomes tabulated 

Soy Isofla 13 3.7±1 Other SD ∆∆ -0.51 (95% CI: -1.62, +0.61) 

E2 1o

Control/Pl 13 3.2±1.4 

Soy Isofla 12 3.2±1.2 SD ∆∆ -0.82 (95% CI: -2.53, +0.897) 

Maskarinec 

2002 

FSH 1o

Control/Pl 16 4.1±1.8 

Maskarinec 

2004 E2 1o ISP+ 91 150 pg/mL ∆ +2 
C-90

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

96 136 pg/mL ∆ -14 

Soy Isofla Maskarinec 2003 Mammographic density 1o Control/Pl 15 Outcomes tabulated 

Soy bread 19 

Mc Michael 

Philips 1998 

epithelial cells in 

the S phase 

progesterone 

receptor 

expression 

1o normal 

unsupplemente

d (without soy) 

diet 

29 

Outcomes tabulated 

ISP 10 47±13 mg/dL SD f/up 47±11 

HDL 1o casein 10 47±13 46±10 

ISP 10 110±25 mg/dL SD f/up 68±21 

LDL 1o casein 10 110±25 67±19 

ISP 10 171±32 mg/dL SD f/up 127±24 

TC 1o casein 10 171±32 125±24 

ISP 10 68±32 mg/dL SD f/up 63±25 

Meinertz 1988 

Tg 1o casein 10 68±32 56±14 

ISP 11 1.49±0.32 mmol/L SD ∆F +16% 

HDL 1o casein 11 same 

ISP 11 2.64±0.97 mmol/L SD ∆F -16% 

LDL 1o casein 11 

ISP 11 4.43±0.98 mmol/L SD ∆F -4% 

TC 1o casein 11 same 

ISP 11 0.65±0.23 mmol/L SD ∆F +2% 

Meinertz 1989 

Tg 1o casein 11 same 

casein 12 mmol/L SD f/up 1.27±0.23 

HDL 1 extracted 12 1.34±0.22 

o

intact Soy 12 1.40±0.19 

casein 12 2.05±0.60 mmol/L SD f/up 1.65±0.35 

LDL 1 extracted 12 2.17±0.52 1.71±0.41 

o

intact Soy 12 2.16±0.50 1.61±0.36 

casein 12 4.02±0.87 mmol/L SD f/up 3.15±0.43 

TC 1 extracted 12 4.16±0.64 3.25±0.37 

o

intact Soy 12 4.15±0.86 3.39±0.34 

casein 12 0.87±0.30 mmol/L SD f/up 0.74±0.20 

Meinertz 2002 

Tg 1o

extracted 12 0.92±0.34 0.66±0.14 
C-91

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

 intact Soy 12 1.00±0.43 0.83±0.22 

high Isofl 13 47.8±0.5 mg/dL SE f/up 48.8±1.1 

HDL 1 low Isofla 13 48.6±1.1 o

no Isoflav 13 47.3±1.0 

high Isofl 13 84.4±1.0 mg/dL SE f/up 79.8±2.0 

LDL 1 low Isofla 13 86.8±2.0 o

no Isoflav 13 88.7±1.9 

high Isofl 13 143.8±1.1 mg/dL SE f/up 139.1±2.9 

TC 1 low Isofla 13 146.3±2.9 o

no Isoflav 13 148.7±2.7 

high Isofl 13 56.3±1.6 mg/dL SE f/up 52.4±3.8 

Tg 1 low Isofla 13 54.3±3.8 o

no Isoflav 13 62.9±3.5 

high Isofl 13 14.59±0.63 

low Isofla 13 15.16±0.63 

Merz- Demlow 

2000 

Lp(a) 1o

no Isoflav 13 

nd mg/dL SE 

 14.64±0.58 

Soy 23 77±1.9 SE 

∆F -2.00±1.7 

DBP 1o dairy 23 77±1.9 

Soy 23 1.28±0.09 mmol/L SE 

∆F 0.06±0.03 

HDL 1o dairy 23 1.28±0.09 

Soy 23 4.13±0.24 mmol/L SE 

∆F -0.05±0.10 

LDL 1o dairy 23 4.13±0.24 

Soy 23 15.4±26.0 mg/dL SE 

∆F -0.30±-0.87 

Lp(a) 1o dairy 23 15.4±26.0 

SAC (Large Soy 23 13.0±0.07 mL/mmHg SE 

∆F -0.03±0.04 

Arteries) 1o dairy 23 13.0±0.07 

SAC (Small Soy 23 5.8±0.6 mL/mmHg SE 

∆F -0.05±0.36 

Arteries) 1o dairy 23 5.8±0.6 

Soy 23 132±2.9 SE 

∆F -0.60±1.7 

SBP 1o diary 23 132±2.9 

Soy 23 6.00±0.25 mmol/L SE 

∆F 0.00±0.13 

TC 1o control 23 6.00±0.25 

Soy 23 1.30±0.14 mmol/L 

∆F -0.02±0.10 

Meyer BJ 2004 

Tg 1o dairy 23 1.30±0.14 

E2 1o Soy 14 4.44 Other SE f/up 4.40 Mitchell 2001 FSH 1o Soy 14 35.21 Other SE f/up 33.38 

Morabito 2002 BMD: Femoral 1o Placebo 30* 0.689±0.06 Other SE 

∆ -0.65±0.1 
C-92

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Neck Genistein 30* 0.687±0.05 3.6±3 

Placebo 30* 0.934±0.07 g/cm2 SE 

∆ -1.6%±0.3 BMD: Lumbar 1o Genistein 30* 0.915±0.07 3%±2 

Placebo 30 10±4 SD f/up 9.6±3 bAP 1o Genistein 30 9.7±1.2 12±4 Placebo 30 77±14 Other SD f/up 73±7.3 E2 1o Genistein 30 73±2.9 77±2.9 

Soy Flour 23 84.52±4.63 Other SE f/up 83.17±4.62 

FSH 1o Control/Pl 24 82.93±3.85 74.84±4.64 

Soy flour 23 1.73±0.09 mmol/L SE f/up 1.68±0.10 

HDL 1o Control/Pl 24 1.64±0.06 1.60±0.06 

Soy flour 23 6.09±0.21 mmol/L SE f/up 5.82±0.20 

TC 1o Control/Pl 24 5.93±0.17 5.69±0.21 

Soy flour 23 1.07±0.13 mmol/L SE f/up 1.05±0.15 

Tg 1o Control/Pl 24 1.08±0.10 1.12±0.15 

Soy flour 28 6±0.5 no unit SE f/up 3.5±0.6 

Murkies 1995 

Vasomotor 

Symptoms: Flush 

Score 

1o Control/Pl 30 5.3±0.5 4±0.6 

placebo+0 7 67±9 mg/dL SD f/up 71±10 

placebo+1m 7 62±21 60±19 

SPI+0.5mgE 8 64±15 68±15 

HDL 2o

SPI+1mgE 8 69±16 64±17 

placebo+0 7 125±17 mg/dL SD f/up 118±15 

placebo+1m 7 164±43 168±105 

SPI+0.5mgE 8 120±28 120±24 

LDL 2o

SPI+1mgE 8 129±35 107±37 

placebo+0 7 211±12 mg/dL SD f/up 209±18 

placebo+1m 7 261±15 244±19 

SPI+0.5mgE 8 212±29 213±22 

TC 2o

SPI+1mgE 8 216±25 203±44 

placebo+0 7 99±55 mg/dL SD f/up 87±24 

placebo+1m 7 191±89 256*±150 

SPI+0.5mgE 8 116±60 119±58 

Murray M 2003 

Tg 2o

SPI+1mgE 8 97±38 150±58 

Soymilk 21 98.0±85.0 SD f/up 65.4±51.7 

Nagata C 1998 E2 1o Control/Pl 23 84.8±74.8 93.6±90.1 

Nagata 2001 testosterone 1o Soymilk 17 16.3 f/up -2.2 
C-93

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

 Control/Pl 17 15.6 -0.4 

Diene Oxidation Isoflavone 15 ND SD f/up 14.1±1.9 

Rate 1o placebo 15 ND 14.4±2.3 

Isoflavone 21 1.30±0.43 mmol/L SD f/up 1.23±0.31 HDL 1o placebo 21 1.30±0.43 1.30±0.39 Isoflavone 15 ND min SD f/up 53.2±5.2 

Lagtime: Copper 1o placebo 15 ND 53.5±5.7 

Isoflavone 21 3.57±0.84 mmol/L SD f/up 3.43±0.85 LDL 1o placebo 21 3.57±0.84 3.35±0.14 Isoflavone 21 86±10 SD f/up 80±10 

MAP 1o placebo 21 86±10 80±12 

Max. Diene Isoflavone 15 nd nmol/mg SD f/up 406.0±41 

Concentration 1o placebo 15 nd 409.0±45 

Isoflavone 21 0.67±0.33 SD f/up 0.99±0.54 

SAC 1o placebo 21 0.67±0.33 0.81±0.4 

TBARS (after Isoflavone 15 nd SD f/up 72.0±14 

oxidation) 1o placebo 15 nd 70.0±16 

Isoflavone 21 5.54±0.94 mmol/L SD f/up 5.37±0.93 TC 1o placebo 21 5.54±0.94 5.25±1.28 Isoflavone 21 1.45±0.71 mmol/L SD f/up 1.53±0.99 

Nestel P 1997 

Tg 1o placebo 21 1.45±0.71 1.30±0.67 

Isoflavones 1st 56 1.16±1.03 mg/L SD f/up 1.10±0.91 

CRP Placebo 1st 56 1.10±0.79 1.10±0.84 

Isoflavones 1st 28 0.140±0.085 Other SD f/up 0.138±0.144 

E2 2o Placebo 1st 28 0.127±0.085 0.141±0.156 

Isoflavones 1st 28 79.9±34.5 Other SD f/up 79.5±32 

FSH 2o Placebo 1st 28 78.8±31.3 77.8±30.7 

Isoflavones 1st 28 2±0.9 no unit SD f/up 1.8±1.0 

Nikander 2003 

Vasomotor 

Symptoms: Score 1o Placebo 1st 28 2.1±0.8 1.8±0.9 

2o Isoflavones 1st 56 5.9±2.0 mmol/L SD f/up 5.5±1.4 

2-hr OGTT Control/Pl 56 6.0±1.8 6.3±2.2 

Isoflavones 1st 28 14.6±5.8 mg/L SD 

∆ 0.00±2.5 

bAP 1o placebo 28 14.7±6.2 0.5±2.3 

Isoflavones 1st Fasting Blood 56 5.1±1.1 mmol/L SD f/up 5.6±2.2 

Glucose 2o Control/Pl 56 5.1±0.9 5.1±0.9 

Isoflavones 1st 56 1.78±0.45 mmol/L SD 

∆ -0.028±0.26 

Nikander 2004 

HDL 2o Control/Pl 56 1.76±0.38 -0.008±0.27 
C-94

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Isoflavones 1st 56 3.87±0.93 mmol/L SD 

∆ +0.28±0.63 

LDL 2o Control/Pl 56 3.80±1.17 -0.06±0.68 

Isoflavones 1st LDL: Baseline > 26 nd mmol/L SD 

∆ +0.65±0.60 

162 mg/dL 2o Control/Pl 26 nd -0.45±0.67 

Isoflavones 1st 56 171.2±204.8 mg/L SD 

∆ +8.7±66.9 

Lp(a) 2o Control/Pl 56 175.8±221.7 -8.6±79.1 

Isoflavones 1st 28 71.9±48.1 SD 

∆ -2.4±22.7 

NTx 1o Control/Pl 28 73.7±49.1 +3.1±37.8 

Isoflavones 1st 56 5.88±0.97 mmol/L SD 

∆ +0.14±0.95 

TC 2o Control/Pl 56 5.83±1.04 +0.06±0.67 

Isoflavones 1st 56 1.22±0.57 mmol/L SD 

∆ +0.015±0.48 

Tg 2o Control/Pl 56 1.25±0.53 +0.005±0.39 

Soy diet liquid 9 12.7 mg/L -2.7 

Nilausen 1999 Lp(a) 1o Casein, liquid 9 12.0 mg/L SEM 

∆ -7.2 

Fasting Blood Soya milk 12* 5.3±0.1 mmol/L SE 

∆ +0.1±0.1 

Glucose 1o oat milk 

Soya milk 12* 1.1±0.1 mmol/L SE 

∆ 0.0±0.0 

HDL 1o oat milk 

Soya milk 12* 2.9±0.3 mmol/L SE 

∆ -0.2±0.1 

LDL 1o oat milk 

Soya milk 12* 4.4±0.3 mmol/L SE 

∆ -0.1±0.1 

TC 1o oat milk 

Soya milk 12* 0.9±0.1 mmol/L SE 

∆ +0.1±0.1 

Onning G 1998 

Tg 1o oat milk 

Pap A 1983 Secretin- pancreozymin 1o Soy flour 34 Outcomes tabulated 

Soy flour 10 

Pap A 1984 

Pancreatic 

enzyme secretory 

capacity 

1o cholecystokinin

-octapeptide 10 

Outcomes tabulated 

Isoflavone 22 9.9±4.5 no unit SD f/up 4.6±3.8 

Penotti 2003 Vasomotor Symptoms: per wk 1o Control/Pl 27 8.6±2.9 4.0±3.9 

ISP56 24 17.5 (95% CI: 8.1-37.9) f/up 24.5 (95% CI: 11.7-51.5) Persky V 2002 

E2 1o

ISP90 23 9.7 (95% CI: 3.0-31.4) 10.8 (95% CI: 3.9-30.1
C-95

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

ISP56 24 39.7 (95% CI: 34.6-44.8) f/up 36.8 (95% CI: 30.7-42.9) 

FSH 1o

ISP90 23 43.7 (95% CI: 34.9-52.4) 44.0 (95% CI: 37.0-51.0) 

ISP56 24 2.22 (95% CI: 1.94-2.54) f/up 2.05 (95% CI: 1.83-2.29) ISP90 22 2.04 (95% CI: 1.68-2.49) 2.22 (95% CI: 1.79-2.75) TSH 1 

o

Control/Pl 24 2.25 (95% CI: 1.82-2.79) 2.00 (95% CI: 1.65-2.43) 

E2 pre 1o ISP+ 14 81.2 pg/mL 

∆ +8.6 

Petrakis 1996 

E2 post 1o ISP+ 10 53.3 pg/mL 

∆ -0.5 

Soy 25 15.8±7.3 SD f/up 17.7±6.7 

E2 1o Control/Pl 25 14.6±6.0 12.3±3.8 

Soy 25 76.8±13.4 SD f/up 77.7±19.6 FSH 1o Control/Pl 25 75.2±28.7 82.5±30.7 Soy 25 43.95±11.31 mg/dL SD f/up 57 

HDL 1o Control/Pl 25 48.10±12.96 48 

Soy 25 151.50±39.22 mg/dL SD f/up 132 

LDL 1o Control/Pl 25 130.50±23.57 143 

Soy 25 229.65±31.58 mg/dL SD f/up 217 

TC 1o Control/Pl 25 203.75±25.08 204 

Soy 25 150.35±94.38 mg/dL SD f/up 150 

Petri NE 2004 

Tg 1o Control/Pl 25 139.00±68.93 143 

Soy flour 24 0.96±0.18 mmol/L SD f/up 0.95±0.16 

ISP w/fiber 24 0.96±0.18 0.91±0.15 ISP w/fiber 24 0.96±0.18 0.91±0.15 HDL 1o

control 24 0.96±0.18 0.92±0.14 

Soy flour 24 4.53±0.61 mmol/L SD f/up 4.30±0.78 

ISP w/fiber 24 4.53±0.61 4.15±0.75 

ISP w/cell 24 4.53±0.61 4.17±0.65 

LDL 1o

control 24 4.53±0.61 4.64±0.87 

Soy flour 25 5.90±0.70 mmol/L SD f/up 5.61±0.88 

ISP w/fiber 25 5.90±0.70 5.45±0.81 

ISP w/cell 25 5.90±0.70 5.44±0.69 

Potter S 1993 

TC 1o

control 25 5.90±0.70 6.10±1.04 
C-96

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Soy flour 23 1.95±0.82 mmol/L SD f/up 2.12±0.86 

ISP w/fiber 23 1.95±0.82 2.00±0.70 

ISP w/cell 23 1.95±0.82 2.00±0.75 Tg 1o

control 23 1.95±0.82 2.29±0.96 

ISP56 23 

Potter 1998 BMD 1 ISP90 21 o

Nonfat milk 22 

Lumbar spine BMD increased significantly in the high-dose group (soy protein wi

compared to control. 

Soya 24* 1.58±0.44 mmol/L SD ∆∆ +0.01 (95% CI: +0.10, -0.09) 

HDL 1o

placebo 28* 1.56±0.43 

Soya 24* 10.52±3.68 mmol/L SD ∆∆ -1.74 (95% CI: -0.87, -2.60) 

Homocysteine 1o

placebo 28* 9.65±2.27 

Soya 24* 5.13±0.48 mmol/L SD ∆∆ -0.27 (95% CI: -0.06, -0.49) 

LDL 1o

placebo 28* 5.15±0.74 

Soya 24 272±341 g/L = mg/mL SD ∆∆ +43.6 (95% CI: +111.0

-23.9) 

Lp(a) 1o

placebo 24 341±495 

Soya 24* 7.50±0.57 mmol/L SD ∆∆ -0.25 (95% CI: -0.01, -0.50) 

TC 1o

placebo 28* 7.68±0.54 

Soya 24* 1.76±0.78 mmol/L SD ∆∆ +0.06 (95% CI: +0.35, -0.22) 

Puska P; 2002 

Tg 1o

placebo 28* 1.81±1.30 

Soya 69 80.5±8.7 mm Hg SD f/up 80.6±8.2 DBP 1o placebo 74 81.1±9.4 81.3±9.7 Soya 69* 1.67±0.53 mmol/L SD ∆∆ +0.01 (: -0.05, 0.03) 

HDL 1o placebo 74* 1.72±0.45 

Soya 69* 10.41±2.74 mmol/L SD ∆∆ +0.58 (95% CI: -1.48, 0.32) 

Homocysteine 1o

placebo 74* 11.16±5.50 

Soya 69* 5.11±0.69 mmol/L SD ∆∆ -0.40 (95% CI: 0.25, 0.55) 

LDL 1o

placebo 74* 5.13±0.75 

Soya 69 130.0±15.8 mm Hg SD f/up 129.6±15.8 

Puska P; 2004 

SBP 1o placebo 74 132.4±17.1 131.3±15.7 
C-97

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Soya 69* 7.53±0.79 mmol/L SD ∆∆ -0.40 (95% CI: -0.26, -0.55) 

TC 1o

placebo 74* 7.59±0.77 

Soya 69* 1.68±0.80 mmol/L SD ∆∆ 0 (95% CI: -0.15, 0.15) 

Tg 1o placebo 74* 1.67±0.58 

Isoflavones 12 ∆∆ -30% 

Quella 2000 Hot flash score 1o Placebo 177 /149 13 1 score unit -32% 

Ross 1995 PDGF 1o tofu 23 Outcomes tabulated 

Soy milk 20* 100.3±8.8 mm Hg SD 

∆ -15.9±9.8 

DBP Control/Pl 20* 99.2±5.4 -3.7±5.0 

Soy milk 20* 155±12.5 mm Hg SD 

∆ -18.4±10.7 

Rivas M; 2002 SBP Control/Pl 20* 151.7±13.8 -1.4±7.2 

Isoflavones Although a crossover trial, the data were analyzed descriptively in the study. The pe

arms was calculated as follows: (# subjects reported no improvement after soy treatmafter placebo treatment) / (# reported no improvement after soy treatment). Dropouts analysis does not consider time effect (i.e.. the order of getting treatments). 

Russo 2003 Menopausal symptoms 1o Placebo 47 

No significant difference in the overall improvement rate of menopausal symptoms b

Soy 25 87.1±1.8 mm Hg SE 

∆ -5.1 

DBP Control/Pl 25 80.8±10.2 -1.7 

Soy 25 53.7±2.0 mg/dL SE 

∆ 3.7 

HDL Control/Pl 25 55.0±2.5 4.7 

Soy 25 142.0±3.0 mm Hg SE 

∆ -10.8 

SBP Control/Pl 25 134.0±3.2 

Soy 25 239.5±7.9 mg/dL SE 

∆ -14.8 

Sagara M 2004 

TC Control/Pl 25 231.5±7.2 -5.0 

Saxena 1999 Misc. outcomes Soy diet 45 Outcome tabulated 

Soy extract 20* 27±5.2 SD error 

Scambia 2000 Vasomotor Symptoms: per wk 1o Control/Pl 19* 33±5.1 

bAP 1o Soy 42 19.4±9.3 SD f/up 20.5±12.5 

E2 2o Soy 42 17.4±7.0 SD f/up 18.9±12.4 

FSH 2o Soy 42 54.1±23.4 SD f/up 52.5±20.8 

LDL oxidation lag 

time 1o Soy 42 34.9±6.8 SD f/up 38.2±7.6 

NTx 1o Soy 42 52.4±26.3 SD f/up 45.1±21.1 

Scheiber 2001 

Serum 

Osteocalcin 1o Soy 42 5.8±2.1 SD f/up 6.4±2.1 

Secreto 2004 Vasomotor Symptoms: Score 1o Isoflavone 61 Median=24 (IQR: 20-30) SD 

∆ 9.8±11.4 
C-98

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Isoflavone 59 Median=25 (IQR: 19-30) 8.9±8.4 

Melatonin 54 Median=25.5 (IQR: 16-31) 7.3±8.1 

Control/Pl 58 Median=23 (IQR: 17-32) 9.2±9.9 

Soy protein 13 52±14 mg/dL SD 

∆ -8±6 

HDL Control/Pl 11 46±12 -4±8 

Soy protein 13 241±38 mg/dL SD 

∆ -16±22 

TC Control/Pl 11 221±21 -22±18 

Soy protein 13 97±48 mg/dL SD 

∆ +40±66 

Shorey R 1981 

Tg Control/Pl 11 130±56 +12±50 

Soy 20 135/82±4/2 mm Hg SE f/up 125/80±4/1 

BP 1o placebo 20 135/82±4/2 126/80±4/2 

Soy 20 1.42±0.07 mmol/L SE f/up 1.33±0.06 

HDL 1o placebo 20 1.42±0.07 1.34±0.06 

Soy 20 3.94±0.26 mmol/L SE f/up 3.61±0.25 

LDL 1o placebo 20 3.94±0.26 3.69±0.22 

Soy 20 nd mg/L SE f/up 166 (IQR: 53-855) 

Lp(a) 1o placebo 20 nd 179 (IQR: 43-720) 

Soy 20 5.86±0.29 mmol/L SE f/up 5.45±0.29 

TC 1o placebo 20 5.86±0.29 5.52±0.27 

Soy 20 1.12±0.13 mmol/L SE f/up 1.12±0.15 

Tg 1o placebo 20 1.12±0.13 1.07±0.09 

Soy 20 % f/up +2 

Simons L 2000 

FMD 

(RH) 1o placebo 20 2.1 +1.2 

Soya 21 6.39±0.95 mmol/L SD 

∆ -7.8% 

LDL 1o Control/Pl 21 6.41 

Soya 21* 8.74±0.74 mmol/L SD 

∆ -6.2% Sirtori 1999 TC 1o Control/Pl 21* Same -3.9% 

Soya 20 226 mmol/L f/up 233 

LDL 1o Control/Pl 20 225 235 

Soya milk 20 314 mmol/L SD f/up 308 

Sirtori 2002 TC 1o Control/Pl 20 318 321 

genistein 30 80±7 mm Hg SD f/up 79±12 

DBP 1o Control/Pl 30 77±10 78±7 

genistein 30 1.2±0.5 mmol/L SD f/up 1.2±0.6 

Squadrito 2002 

HDL 1o Control/Pl 30 1.2±0.3 1.3±0.4 
C-99

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

genistein 30 3.6±0.4 mmol/L SD f/up 3.6±0.4 

LDL 1o Control/Pl 30 3.8±0.9 3.7±0.2 

genistein 30 113±11 mm Hg SD f/up 110±13 

SBP 1o Control/Pl 30 112±13 113±15 

genistein 30 5.3±1.1 mmol/L SD f/up 5.5±0.9 

TC 1o Control/Pl 30 5.4±0.8 5.5±0.7 

genistein 30 1.5±1.8 mmol/L SD f/up 1.8±1.5 

Tg 1o Control/Pl 30 1.7±1.5 1.6±1.2 

genistein 27 24±4 mL/dL/mi n f/up 35±9 

DBA FMD (RH) 1o

Control/Pl 26 24±6 25±8 

DBA FMD (RH) genistein 27 3.5±0.7 Diam mm f/up 4.0±0.5 

(size) 1o Control/Pl 26 3.5±0.9 3.5±0.9 

genistein 27 19.6 pg/mL f/up +0.6 

Squadrito 2003 

E2 1o Control/Pl 26 19.1 +0.2 

ISP w/Isof 24 % +13 

ISP w/o is 24 % +15 

Brachial Artery 

Reactivity 1o Control/Pl 24 % f/up (graph) +20 

ISP w/Isof 24 1.55±0.1 mmol/L SE f/up 1.49±0.1 

HDL 1 ISP w/o is 24 1.55±0.1 1.55±0.1 o

Control/Pl 24 1.55±0.1 1.61±0.1 

ISP w/Isof 24 2.89±0.1 mmol/L SE f/up 2.86±0.1 

LDL 1 ISP w/o is 24 2.89±0.1 2.87±0.1 o

Control/Pl 24 2.89±0.1 2.94±0.1 

ISP w/Isof 24 4.91±0.1 mmol/L SE f/up 4.82±0.1 

TC 1 ISP w/o is 24 4.91±0.1 4.92±0.2 o

Control/Pl 24 4.91±0.1 5.00±0.1 

ISP w/Isof 24 1.03±0.1 mmol/L SE f/up 1.04±0.1 

ISP w/o is 24 1.03±0.1 1.08±0.1 

Steinberg 2003 

Tg 1o

Control/Pl 24 1.03±0.1 0.98±0.1 

ISP w/Isof 24 36 Weekly ∆ -50% 

St Germain 2001 Hot flash 1 ISP w/Isof 24 36.5 frequency 0 

o

Wheat protein 21 32 -47% 

ISP 7 nd pg/mL f/up -18.3 

Stroescu 2001 estradiol 1o Control/Pl 7 nd -17.4 

Swain 2002 FSH 1 ISP w/Iso 24 o

ISP w/o Iso 24 

Outcomes tabulated 
C-100 

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

 Control/Pl 21 

ISP w/Iso 24 

estradiol 1 ISP w/o Iso 24 o

Control/Pl 21 

Outcomes tabulated 

Soy 27 65.7±12,5 mg/dL SD f/up 63.4±10.2 

HDL 1o Control/Pl 25 63.3±8.9 65.0±9.8 

Soy 27 91.3±22.9 mg/dL SD f/up 86.0±32.0 

LDL 1o Control/Pl 25 94.2±20.2 96.7±19.4 

Soy 27 176.6±24.2 mg/dL SD 

∆ -10.9 

TC 1o Control/Pl 25 176.7±23.8 

Soy 27 98.2±51.4 mg/dL SD f/up 81.6±32.0 

Takatsuka 2000 

Tg 1o Control/Pl 25 95.9±45.6 80.0±29.6 

Soy 105 76±1 mm Hg SE 

∆ -4.3±0.8 

DBP 1o Control/Pl 108 76±2 -1.9±0.7 

Soy 55 11.1±1.4 mmol/L SE 

∆ 2.7±1.5 FSH: Men 1o Control/Pl 53 9.2±0.8 4.7±2.7 

Soy 50 97.4±6 mmol/L SE 

∆ 1.1±3.4 FSH: women 1o Control/Pl 55 112.7±6 -2.6±3.2 

Soy 105 1.44±0.1 mmol/L SE 

∆ -0.04±0.03 HDL 1o Control/Pl 108 1.51±0.1 -0.11±0.04 

Soy 105 3.9±0.1 mmol/L SE 

∆ -0.42±0.07 LDL 1o Control/Pl 108 3.8±0.1 -0.28±0.07 

Soy 105 286 (95% CI: 207-365) mg/L SE 

∆ 42 (95% CI: 17-67) 

Lp(a) 1o Control/Pl 108 341 (95% CI: 251-433) 4 (95% CI: -22 –30) 

Soy 105 0.53 (95% CI: 0.49-0.58) SE 

∆ 0.04 (95% CI: -0.003-0.08) SAC: combined 1o

Control/Pl 108 0.56 (95% CI: 0.49-0.63) 0.01 (95% CI: -0.06-0.08) 

Soy 55 0.54 (95% CI: 0.47-0.61) SE f/up 0.60 (95% CI: 0.53-0.68) SAC: men 1o

Control/Pl 53 0.62 (95% CI: 0.51-0.73) 0.62 (95% CI: 0.55-0.68) 

Soy 50 0.52 (95% CI: 0.46-0.58) SE f/up 0.54 (95% CI: 0.47-0.61) SAC: women 1o

Control/Pl 55 0.50 (95% CI: 0.43-0.56) 0.52 (95% CI: 0.49-0.63) 

Soy 105 130±2 mm Hg SE 

∆ -7.5±1.2 

Teede HJ 2001 

SBP 1o Control/Pl 108 128±2 -3.6±1.1 
C-101 

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Soy 105 5.9±0.1 mmol/L SE 

∆ -0.55±0.09 TC 1o Control/Pl 108 5.9±0.1 -0.4±0.09 

Soy 55 16.8±0.9 nmol/L SE 

∆ -1.5±0.9 Testosterone 1o Control/Pl 53 15.8±0.8 -1.0±0.6 

Soy 105 1.2±0.1 mmol/L SE 

∆ -0.19±0.05 

Tg 1o Control/Pl 108 1.2±0.1 -0.01±0.05 

FMD Soy % 

∆ -3.5 

(RH) in 

♂ 1o Control/Pl 96 0 

FMD Soy % 

∆ +0.5 

(RH) in post 

♀ 1o Control/Pl 83 -1.0 

Soy 30 1.91±0.33 SE 

∆ 0.42±0.2 

Teede HJ 2004 CRP 1o Control/Pl 22 1.39±0.22 0.48±0.2 

20 g ISP 15 1.07±0.06 mmol/L SE 

∆ -0.039 

30 g ISP 18 1.13±0.09 0 40 g ISP 17 1.11±0.08 0 50 g ISP 15 1.13±0.05 0.039 

HDL 1o

Control/Pl 16 1.10±0.08 -0.026 

20 g ISP 15 55.3 (95% CI: 7.6-266.4) SE f/up 52.3 (95% CI: 6.5-326.2) 30 g ISP 18 64.2 (95% CI: 3.1-310.7) 75.7 (95% CI: 4.2-272.6) 40 g ISP 17 61.3 (95% CI: 8.4-672.7) 59.0 (95% CI: 7.3-578.7) 50 g ISP 15 74.1 (95% CI: 3.3-469.2) 68.0 (95% CI: 2.3-514.7) 

Lp(a) 1o

Control/Pl 16 42.8 (95% CI: 1.0-340.4) 43.9 (95% CI: 0.0-410.1) 

20 g ISP 15 5.98±0.22 mmol/L SE 

∆ -0.126 

30 g ISP 18 6.01±0.18 -0.115 40 g ISP 17 5.96±0.20 -0.053 50 g ISP 15 6.28±0.18 -0.167 

TC 1o

Control/Pl 16 6.08±0.22 0.222 

20 g ISP 15 1.77±0.12 mmol/L SE 

∆ 0.632 

30 g ISP 18 2.52±0.31 0.782 40 g ISP 17 2.05±0.22 0.443 50 g ISP 15 2.18±0.28 0.872 

Teixeira 2000 

Tg 1o

Control/Pl 16 2.14±0.28 0.664 
C-102 

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

30 g ISP 34 1.48±0.42 mmol/L SD ∆∆ 0.04 (95% CI: -0.02, 0.10) 50 g ISP 31 1.35±0.33 

Control 30 g 36 1.26±0.39 

HDL 

Control/Pl 29 1.33±0.37 

30 g ISP 34 10.0±2.2 Other SD ∆∆ -0.8 (95% CI: -1.4, -0.250 g ISP 31 10.6±2.9 

Control 30 g 36 10.1±2.2 Homocysteine 

Control/Pl 29 10.6±2.5 

30 g ISP 34 4.81±0.54 mmol/L SD ∆∆ -0.26 (95% CI: -0.43, -0.09) 50 g ISP 31 4.58±0.50 

Control 30 g 36 4.88±0.66 

LDL 

Control/Pl 29 4.96±0.50 

30 g ISP 34 437±410 mg/L SD ∆∆ 25 (95% CI: -4, 54) 50 g ISP 31 417±498 

Control 30 g 36 405±314 Lp(a) 

Control/Pl 29 367±409 

30 g ISP 34 6.86±0.67 mmol/L SD f/up 6.00±0.55 50 g ISP 31 6.52±0.63 5.61±0.71 

Control 30 g 36 6.84±0.72 6.29±0.54 TC 

Control/Pl 29 6.90±0.54 6.13±0.53 

30 g ISP 34 1.28±0.38 mmol/L SD ∆∆ -0.04 (95% CI: -0.22, 0.14) 50 g ISP 31 1.33±0.70 

Control 30 g 36 1.57±0.76 

Tonstad 2002 

Tg 

Control/Pl 29 1.46±0.67 

Isoflavone 12 66.2±15.8 SE f/up 65.1±16.8 

HDL 1o Control/Pl 11 64.9±15.2 68.1±14.2 

Isoflavone 12 148.1±34.7 SE f/up 138.4±36.1 

LDL 1o Control/Pl 11 162.3±24.5 163.9±21.6 

Serum Isoflavone 12 8.5±1.2 SE f/up 7.4±1.1 

Osteocalcin 1o Control/Pl 11 7.2±0.7 7.1±0.6 

Isoflavone 12 226.3±39.7 SE f/up 215.4±44.4 

TC 1o Control/Pl 11 237.6±31.2 240.9±25.4 

Isoflavone 12 94.8±43.9 SE f/up 106.1±51.0 

Uesugi T 2002 

Tg 1o Control/Pl 11 105.2±40.0 97.5±27.5 

Uesugi T 2003 FSH 1o Isoflavone 11 56.5±13.2 SD f/up 55.8±10.8 
C-103 

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

 Control/Pl 10 73.5±12.4 60.9±13.3 

Isoflavone 11 65.2±4.0 mg/dL SD f/up 64.0±4.1 

HDL 1o Control/Pl 10 70.6±67.1 67.1±5.5 

Isoflavone 11 223.7±14.7 mg/dL SD f/up 218.7±11.5 

TC 1o Control/Pl 10 221.1±6.3 219.9±7.0 

Isoflavone 11 126.5±17.4 mg/dL SD f/up 112.3±16.0 

Tg 1o Control/Pl 10 117.7±15.4 135.2±9.9 

Soy Isofla 59 76.2 f/up 85.3 

FSH 2o Control/Pl 63 79.3 86.3 

Soy Isofla 59 52.6 f/up 53.3 NTx 2o Control/Pl 63 54.8 53.4 

Serum Soy Isofla 59 13.43 f/up 13.75 

Osteocalcin 2o Control/Pl 63 13.75 14.89 

Soy Isofla 59 1.52 ∆ -62% 

Upmalis 2000 

Vasomotor: Night 

Sweats/day 1o Control/Pl 63 1.89 -34% 

Oats/Soy 32* 1.59 mmol/L ∆ -0.01 

Wheat/Soy 31* 1.66 -0.01 

Oats/Milk 32* 1.74 -0.03 

HDL 

Control/Pl 32* 1.64 -0.02 

Oats/Soy 32* 3.89 mmol/L ∆ -0.27 

Wheat/Soy 31* 3.80 0.01 

Oats/milk 32* 4.01 -0.23 

LDL 

Control/Pl 32* 3.91 -0.03 

Oats/Soy 32* 6.17 mmol/L ∆ -0.21 

Wheat/Soy 31* 6.06 0.01 

Oats/milk 32* 6.33 -0.24 

Van Horn 2001 

TC 

Control/Pl 32* 6.21 0.00 

Soy beverage 59 4.7 Weekly ∆ -26% 

Van Patten 2002 Hot flash 1o Rice beverage 64 5.2 frequency -35% 

Substitution 19 1.3±0.1 mmol/L SD ∆ +7.7% 

HDL 1 Addition 38 1.4±0.1 -7.1% 

o

Control/Pl 0* 

Substitution 19 6.7±0.5 mmol/L SD ∆ -38.8% 

LDL 1 Addition 38 6.3±0.2 -36.5% 

o

Control/Pl 0 

Substitution 19 8.8±0.4 mmol/L SD ∆ -29.5% 

Verrillo 1985 

TC 1o

Addition 38 8.7±0.2 -29.9% 
C-104 

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

 Control/Pl 0 

Substitution 19 1.7±0.2 mmol/L SD ∆ -11.8% 

Tg 1 Addition 38 2.2±0.6 -18.2% o

Control/Pl 0 

ISP w/ Isofl. 40 81.9±8.1 SD ∆ -0.1±10.2 

DBP 2o Control/Pl 37 82.5±10.4 -3.1±13.1 

ISP w/ Isofl. 40 1.57±0.36 mmol/L SD f/up 1.58±0.35 

HDL 2o Control/Pl 37 1.61±0.38 1.58±0.37 

ISP w/ Isofl. 40 4.13±0.87 mmol/L SD f/up 3.78±0.77 

LDL 2o Control/Pl 37 4.33±0.87 4.01±0.73 

ISP w/ Isofl. 40 160 (Range: 30-1140) mg/L f/up 170 (Range: 20-1030) 

Lp(a) 2o Control/Pl 37 170 (Range: 50-1010) 200 (Range: 40-1190) 

ISP w/ Isofl. 40 127.2±15.8 mm Hg SD ∆ -3.2±16.1 

SBP 2o Control/Pl 37 129.9±15.1 -8.6±20.9 

ISP w/ Isofl. 40 6.37±1.01 mmol/L SD f/up 5.96±0.95 

TC 2o Control/Pl 37 6.55±0.93 6.14±0.82 

ISP w/ Isofl. 40 1.47±0.90 mmol/L SD f/up 1.31±0.60 

Vigna GB 2000 

Tg 2o Control/Pl 37 1.32±0.77 1.19±0.57 

ISP w/ Isofl. U/L SE f/up 22.3±0.5 

bAP 1 ISP w/ Isofl. 22.3±0.6 

o

ISP w/o Isofl. 

17 20.9±0.7 

 24.6±0.6 

ISP w/ Isofl. +0.36 

OC 1 ISP w/ Isofl. nmol/L ∆ +0.6 

o

ISP w/o Isofl. 

17 2.5 

 +0.6 

ISP w/ Isofl. -0.52 ISP w/ Isofl. ∆ -0.07 

Wangen 2000 

(postmenopausal 

women only) 

D-pyr 1o

ISP w/o Isofl. 

17 6.84 

nmol/mm

ol 

creatinine -0.73 

Low Isofla 17 52±17 SD mg/dL 

Uncl

ear 

SD/

SE 

f/up 53.3±0.9 SE 

High Isofl 18 same 52.7±0.9 SE 

No Isoflav 18 same 52.0±0.9 SE 

Wangen K 2001 

HDL 2o

Control/Pl 0 
C-105 

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Low Isofla 17 136±31 SD mg/dL 

Uncl

ear 

SD/

SE 

∆F ND 

High Isofl 18 Same -6.5% 

No Isoflav 18 Same 

LDL 2o

Control/Pl 0 

Low Isofla 17 25±1 SE mg/dL SE f/up 27.2±0.9 SE 

High Isofl 18 Same 27.4±0.8 SE 

No Isoflav 18 Same 26.8±0.8 SE 

Lp(a) 2o

Control/Pl 0 

Low Isofla 17 215±26 SD mg/dL 

Uncl

ear 

SD/

SE 

f/up 193±3 SE 

High Isofl 18 same 191±2 SE 

No Isoflav 18 same 197±2 SE 

TC 2o

Control/Pl 0 

Low Isofla 17 130±114 SD mg/dL 

Uncl

ear 

SD/

SE 

f/up 108±7 SE 

High Isofl 18 Same 108±7 SE 

No Isoflav 18 Same 103±7 SE 

Tg 2o

Control/Pl 0 

Soy qD 42 82.2±11.4 SD 

Uncl

ear 

SD/

SE 

f/up 76.3±1.4 SE 

Soy BID 42 Same 73.7±1.4 

DBP 1o

Control/Pl 42 Same 78.6±1.4 

Soy qD 42 91.7±20.6 SD mg/dL 

Uncl

ear 

SD/

SE 

f/up 92.6±1.4 SE 

Soy BID 42 Same 92.3±1.5 

Washburn 1999 

Fasting Blood 

Glucose 2o

Control/Pl 42 Same 91.8±1.4 
C-106 

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

Soy qD 42 54.9±15.6 SD mg/dL 

Uncl

ear 

SD/

SE 

f/up 52.2±0.9 SE 

Soy BID 42 Same 52.2±0.9 

HDL 1o

Control/Pl 42 Same 53.3±0.9 

Soy qD 42 126.9±38.5 SD mg/dL 

Uncl

ear 

SD/

SE 

∆F -7.5% 

Soy BID 42 Same -7.5% 

LDL 1o

Control/Pl 42 Same 

Soy qD 42 132.0±19.6 SD 

Uncl

ear 

SD/

SE 

f/up 124.2±1.6 SE 

Soy BID 42 Same 125.3±1.6 

SBP 1o

Control/Pl 42 Same 126.6±1.7 

Soy qD 42 208.0±40.5 SD mg/dL 

Uncl

ear 

SD/

SE 

∆F -6% 

Soy BID 42 Same -6% 

TC 1o

Control/Pl 42 Same 

Soy qD 42 131.1±67.1 SD mg/dL 

Uncl

ear 

SD/

SE 

∆F -28 

Soy BID 42 Same -15 

Tg 1o

Control/Pl 42 Same 

Soy qD 42 SE f/up 23.1±4.9 

Soy BID 42 22.3±2.7 

Vasomotor Symptoms: per wk 1o Control/Pl 42 21.3±3.0 

Soy pg/mL f/up ~20 

Watatnabe 2000 E2 1o Control/Pl 19 ~25 

Wong WW 1998 HDL: Baseline < Soy Protein 13 1.01±0.29 mmol/L SD f/up 0.96±0.26 

50/40 mg/DL 

(m/w) 

1o Control/Pl 13 1.06±0.36 0.93±0.29 
C-107 

Study Outcome 

Primary / 

Secondary Cohort N (final) Base Follow-up / Change 

HDL: Baseline > Soy Protein 13 1.06±0.26 mmol/L SD f/up 0.98±0.31 

50/40 mg/DL 

(m/w) 

1o Control/Pl 13 1.06±0.31 0.98±0.28 

LDL: Baseline < Soy Protein 13 2.87±0.49 mmol/L SD f/up 2.53±0.65 

130 mg/dL 1o Control/Pl 13 2.82±0.62 2.69±0.54 

LDL: Baseline > Soy Protein 13 4.68±0.65 mmol/L SD f/up 4.09±1.09 

130 mg/dL 1o Control/Pl 13 4.71±0.67 4.34±0.96 

TC: Baseline < Soy Protein 13 4.40±0.60 mmol/L SD f/up 4.01±0.96 

200 mg/dL 1o Control/Pl 13 4.37±0.75 4.14±0.72 

TC: Baseline > Soy Protein 13 6.78±0.70 mmol/L SD f/up 6.39±0.98 

200 mg/dL 1o Control/Pl 13 6.85±0.72 6.57±0.93 

Tg: LDL <130 Soy Protein 13 1.01±0.36 mmol/L SD f/up 1.11±0.47 

mg/dL 1o Control/Pl 13 1.04±0.55 0.96±0.31 

Tg: LDL >130 Soy Protein 13 2.37±1.34 mmol/L SD f/up 3.00±2.28 

mg/dL 1o Control/Pl 13 2.94±2.64 2.83±1.83 

Wu 2000 E2 1o Soy diet 20 Outcomes tabulated 

ISP+ 

Xu X 2000 

Urinary 

2OHE;Urinary 

16aOHE 

1o

Control/Pl 

18 Outcomes tabulated 

nijiru 12 graphically represented SE f/up graphically represented 

Yamaguchi 2001 ? 6 m 

Serum Osteocalcin 1o ? 6 w 

Soy 17 4.6±0.4 mmol/L SD f/up 4.7±0.4 Yamashita 1998 Fasting Blood Glucose 1o Control/Pl 19 4.7±0.5 4.8±0.3 

Soybean and 

sesame 

20 3.04 nmol/umol creatinine 

∆ -0.95 

Urinary Pyr 1o

Sesame 20 2.65 --0.48 

Soybean and 

sesame 

20 7.6 nmol/umol creatinine 

∆ -2.8 

Yamori 2002 

Urinary D-Pyr 1o

Sesame 20 5.2 +0.7 

Soy Diet 20 8.2±0.6 % SD f/up 12.6±0.6 

FMD (RH) 1o Control/Pl 0* 

Soy Diet 20 23.4±28.6 mg/dL SD f/up 22.2±28.0 

Yildirir 2001 Lp(a) 1o Control/Pl 0* 

∆ = within cohort difference ∆∆ = net difference from the reference group Outcomes tabulated: The results not summarized but the study cited for the outcome in the report 
Appendix D. Peer Reviewers 

Peer Reviewers 

We gratefully acknowledge the following individuals who reviewed the initial draft of this 

Report and provided us with constructive feedback. Acknowledgments are made with the 

explicit statement that this does not constitute endorsement of the report.

 

David Atkins, MD, MPH 

Center for Outcomes and Evidence 

Agency for Healthcare Research and Quality 

Rockville, Maryland 

Katherine M. Newton, PhD 

Center for Health Studies 

Group Health Cooperative 

Seattle, Washington 

D. Lee Alekel, PhD 

Department of Food Science and Human 

 Nutrition

Iowa State University 

Ames, Iowa 

Frank M. Sacks, MD

Nutrition Department 

Harvard School of Public Health 

Boston, Massachusetts 

Elizabeth Jackson, MD 

Department of Medicine 

Division of Cardiovascular Medicine 

University of Massachusetts Medical School 

Worcester, Massachusetts 

Anne Thurn, PhD 

Evidence-Based Review Program

Office of Dietary Supplements 

National Institutes of Health 

Bethesda, Maryland 

Penny Kris-Etherton, PhD, RD 

Pennsylvania State University 

University Park, Pennsylvania 

 

Yvonne T. Van der Schouw, PhD 

Julius Center for Health Sciences and 

 Primary Care 

University Medical Center Utrecht 

Utrecht, Netherlands 

Mindy S. Kurzer, PhD 

Director of Graduate Studies, Nutrition 

Department of Food Science and Nutrition 

University of Minnesota 

St. Paul, Minnesotta 

Linda V. Van Horn, PhD

Department of Preventive Medicine 

Feinberg Cardiovascular Research Institute 

Northwestern University

Chicago,Illinois 

Gertraud Maskarinec, MD, PhD 

Cancer Research Center of Hawaii 

Honolulu, Hawaii 

Connie M. Weaver, Ph.D. 

Foods and Nutrition 

Purdue University 

West Lafayette, Indiana 

D-1