Scavenging of Reactive Carbonyl Species by Dietary Flavonoids From Soymilk, Green Tea, and Blueberry in Humans
Phase: NA
Conditions: Human Health, Reactive Carbonyl Species, Polyphenols
Sponsor: North Carolina Agriculture & Technical State University

 
 
Cover Page for Protocol 
 
NCT number: 
NCT05773794 
Official title of study: 
Scavenging of reactive carbonyl species by dietary flavonoids from Soymilk, green 
tea, and blueberry in humans 
Document date: 
3/15/2023 
Brief Summary: 
This is an interventional study to investigate the formation and pharmacokinetics of 
reactive carbonyl species adducts of dietary polyphenols (soymilk, blueberry and 
green tea) in humans after a single dose of dietary flavonoids. 

Background 
 
Carbonyl stress is the abnormal accumulation of carbonyl metabolites, such as methylglyoxal and acrolein, 
leading to increased modification of protein and DNA and contributing to cell and tissue dysfunction in aging 
and many chronic diseases. Dietary flavonoids have been reported to have the capacity to scavenging of these 
reactive carbonyl species in vitro and in mice. However, this effect has not been demonstrated in humans.  
 
Study Objectives 
 
The goal of this study is to determine the formation and kinetics of reactive carbonyl adducts of dietary 
flavonoids (soymilk, blueberry and green tea) in humans after a single dose of the dietary flavonoids. We 
speculate that the dietary flavonoids (soymilk, blueberry and green tea) can react with endogenous reactive 
carbonyls species to form reactive carbonyl adducts in the body, eventually alleviating the damaging effects of 
reactive carbonyls species on human health. Study on the formation and kinetics of reactive carbonyl adducts of 
dietary flavonoids is also expected to be able to provide substantial evidence for the health effects of regular 
dietary flavonoids (soymilk, blueberry and green tea) consumption in epidemiological studies. 
 
Study Design 
 
This study follows a randomized, crossover design, where participants will consume each intervention 
(soymilk, blueberry, and green tea) in separate study periods with a washout phase in between. 
• 
Study Duration: 17 days 
• 
Number of Participants: 16 healthy adults for each intervention 
• 
Intervention Groups: 
o Dietary Flavonoids (Soymilk) Consumption and Placebo 
o Dietary Flavonoids (Blueberry) Consumption and Placebo 
o Dietary Flavonoids (Green Tea) Consumption and Placebo 
Study Methods- Participant Selection 
Minimum Age: 25 Years   
Maximum Age: 70 Years   
Sex: All   
Criteria: 
 
Inclusion Criteria: 
1. Age 25-70 years 
2. BMI between 18 and 30 
3. Have no known allergy to soy milk 
4. Be not taking antibiotics for six months 
5. Be not currently taking medication 
a. No taking any prescription drugs 
b. If supplements were taken, flavonoid-enriched supplements (see list below) should be 
avoided. 
Major brands Notes: All flavonoid-enriched supplements should be avoided. Soy 
Isoflavones/ tea/blueberry Lipo-Flavonoid Citrus Bioflavonoids Complex Super 
Flavonoids Super Antioxidants Quercetin Supplement Essential-C and flavonoids Milk 
Thistle Other flavonoids supplements, including but not limited: Luteolin, Rutin, etc 
c. No any drugs or supplements within three weeks of the experiment 
6. Be nonsmoking 
7. Have no alcoholic intoxication 

a. No alcoholic addiction 
b. < 3-4 drinks per week (less than 2 glasses (300 mL) per drink) 
c. No alcohol within 3 three weeks of the experiment 
8. Have no extended exposure to industrial wastes 
Exclusion Criteria: 
1. Disease: gout, heart disease, peripheral vascular disease, degenerative kidney, degenerative liver, 
diabetes, GI disorders, or endocrine disorders 
2. Cancer patients 
a. Currently diagnosed cancer patients will be excluded; 
b. Medication free for >2 years could be considered 
Study Methods- Procedures 
1. Dietary Flavonoids (Soymilk) Consumption and Placebo 
Week 1 (Wash-in Period: Days 1–7) 
Sixteen (16) healthy volunteers were recruited and instructed to avoid consuming soymilk, green tea, and 
blueberry products starting one week before the intervention and continuing throughout the entire three-week 
study period. 
Week 2 (First Intervention: Day 8) 
Participants were randomized into two groups: 
• 
Soymilk-first group: Consumed a breakfast including 460 mL of soymilk in a single dose. 
• 
Control-first group: Consumed a breakfast including 460 mL of milk in a single dose. 
Biological sample collection: 
• 
Urine and blood samples were collected at multiple time points over a 24-hour period. 
• 
Fecal samples were collected at different time points over a 48-hour period. 
Participants continued to avoid consuming soymilk, green tea, and blueberry products. 
Week 3 (Cross-over: Day 15) 
Participants switched interventions: 
• 
Those who previously consumed soymilk in Week 2 now consumed milk. 
• 
Those who previously consumed milk in Week 2 now consumed soymilk. 
Biological sample collection: 
• 
Urine and blood samples were collected at multiple time points over a 24-hour period. 
• 
Fecal samples were collected at different time points over a 48-hour period. 
Participants continued to avoid consuming soymilk, green tea, and blueberry products until Day 17. 
 

2. Dietary Flavonoids (Blueberry) Consumption and Placebo 
Week 1 (Wash-in Period: Days 1–7) 
Sixteen (16) healthy volunteers were recruited and instructed to avoid consuming soymilk, green tea, and 
blueberry products starting one week before the intervention and continuing throughout the entire three-week 
study period. 
Week 2 (First Intervention: Day 8) 
Participants were randomized into two groups: 
• 
Blueberry-first group: Consumed a breakfast including 460 mL of blueberry water in a single dose. 
• 
Control-first group: Consumed a breakfast including 460 mL of placebo sweet water in a single dose. 
Biological sample collection: 
• 
Urine and blood samples were collected at multiple time points over a 24-hour period. 
• 
Fecal samples were collected at different time points over a 48-hour period. 
Participants continued to avoid consuming soymilk, green tea, and blueberry products. 
Week 3 (Cross-over: Day 15) 
Participants switched interventions: 
• 
Those who previously consumed blueberry water in Week 2 now consumed placebo sweet water. 
• 
Those who previously consumed placebo sweet water in Week 2 now consumed blueberry water. 
Biological sample collection: 
• 
Urine and blood samples were collected at multiple time points over a 24-hour period. 
• 
Fecal samples were collected at different time points over a 48-hour period. 
Participants continued to avoid consuming soymilk, green tea, and blueberry products until Day 17. 
 
3. Dietary Flavonoids (Green Tea) Consumption and Placebo 
Week 1 (Wash-in Period: Days 1–7) 
Sixteen (16) healthy volunteers were recruited and instructed to avoid consuming soymilk, green tea, and 
blueberry products starting one week before the intervention and continuing throughout the entire three-week 
study period. 
Week 2 (First Intervention: Day 8) 
Participants were randomized into two groups: 
• 
Green tea-first group: Consumed a breakfast including 460 mL of green tea in a single dose. 

• 
Control-first group: Consumed a breakfast including 460 mL of water in a single dose. 
Biological sample collection: 
• 
Urine and blood samples were collected at multiple time points over a 24-hour period. 
• 
Fecal samples were collected at different time points over a 48-hour period. 
Participants continued to avoid consuming soymilk, green tea, and blueberry products. 
Week 3 (Cross-over: Day 15) 
Participants switched interventions: 
• 
Those who previously consumed green tea in Week 2 now consumed water. 
• 
Those who previously consumed water in Week 2 now consumed green tea. 
Biological sample collection: 
• 
Urine and blood samples were collected at multiple time points over a 24-hour period. 
• 
Fecal samples were collected at different time points over a 48-hour period. 
Participants continued to avoid consuming soymilk, green tea, and blueberry products until Day 17. 
 
 
 

Scheme 1. Recruitment, screening, and enrollment for each PK study 
 
 
Obtain IRB approval 
Recruitment: email & flyers 
Informational meetings for volunteers 
Obtain informed consent from volunteers 
Prescreening: health questionnaire 
Medical screening: Assessment of Eligibility 
(20 volunteers will be selected for medical 
screening) 
Randomized to treatment 
(16 volunteers will be selected to participate 
each PK study, and the rest volunteers (4 or 
less) will be on the waiting list to replace 
participants who either discontinue the PK 
study or are not in compliance with the study 
protocol.  
Excluded: Do not qualify for study based on 
health questionnaire 
Excluded: Do not qualify for study based on 
medical screening 

Scheme 2. Experimental design and sample collections of the acute PK study with a crossover design 
 
 
 
 
Statistical Analysis Plan 
 
The primary objective of this study is to evaluate whether dietary flavonoids from soy milk, blueberries and 
green tea can trap reactive carbonyl species in humans by detecting the formation of carbonyl adducts of these 
flavonoids. 
 
Statistical Analysis: ANOVA with repeated measures and post hoc comparisons will be conducted to identify 
metabolites that show significant differences across various time points or treatments. 
 
Power Analysis: A sample size of n=16 subjects per group will provide 80% power to detect metabolites with 
an effect size of 0.809, which is sufficient to assess the expected trapping effects of dietary flavonoids. 
 
 
Volunteer 
Randomized 
to treatment 
(n=16; 8 men 
and 8 
women)
Control: n=8; 4 men and 
4 women
Test food: n=8; 4 men 
and 4 women
Control: n=8; 4 men and 
4 women
Test food: n=8; 4 men 
and 4 women
Day 8
Day 9
Urine: 0, 0-2, 2-4, 4-6,  
24-32 and
6-8, 8-12, 12-24 h 
32-48 h
Blood: 0, 0.5, 1.0, 1.5, 2.0 
3.0, 4.0, 6.0, and 8.0 h
24 h
Day 16
Day 17
Urine: 0, 0-2, 2-4, 4-6, 
24-32 and
6-8, 8-12, 12-24 h 
32-48 h
Blood: 0, 0.5, 1.0, 1.5, 2.0 
3.0, 4.0, 6.0, and 8.0 h
24 h
Days 1-7
Wash-in period
Days 10-15
Washout 
period
Wash-in
1st PK challenge
Wash-out
2nd PK challenge

              INFORMED CONSENT TO PARTICIPATE IN A RESEARCH STUDY 
               
              Adult Participants 
 
North Carolina A&T State University 
Consent Form Version Date: November 22, 2022  
IRB Study #22-0093 
Study Title: Scavenging of reactive carbonyl species by dietary flavonoids in humans 
Principal Investigator: Shengmin Sang 
Principal Investigator Department: Center for Excellence in Post-Harvest Technologies (CEPHT) 
Principal Investigator Phone Number: 704-250-5710 
Principal Investigator Email Address: ssang@ncat.edu 
Funding Source and /or Sponsor: NIH R01  
Study Contact Telephone Number: 704-250-5083, 704-250-5711 
Study Contact Email: hrc_studies@unc.edu, sanglabncat@gmail.com 
 
 
What are some general things you should know about research studies? 
You are being asked to take part in a research study. To join the study is voluntary. 
You may choose not to participate, or you may withdraw your consent to be in the study, for any reason, without 
penalty.  
 
Research studies are designed to obtain new knowledge. This new information may help people in the future. You 
may not receive any direct benefit from being in the research study. There also may be risks to being in the studies. 
Deciding not to be in the study or leaving the study before it is done will not affect your relationship with the 
researcher, your health care provider, or North Carolina A&T State University. If you are a patient with an illness, you 
do not have to be in the research study in order to receive health care. 
 
Details about this study are discussed below. It is important that you understand this information so that you can 
make an informed choice about being in this research study. 
 
You will be given a copy of this content form. You should ask the researchers named above, or staff members 
who may assist them, any questions you have about this study at any time. 
 
What is the purpose of this study? 
The purpose of this research study is to determine whether drinking soy milk can lower the harmful reactive 
carbonyl species (RCS) in humans. RCS is derived from the oxidation of carbohydrates, lipids, and amino acids 
in the body. Abnormal accumulation of RCS contributes to cell and tissue dysfunction in aging and many chronic 
diseases. Soy isoflavones have been reported to have the capacity to scavenging of these reactive carbonyl species 
in vitro and in mice. However, this effect has not been demonstrated in humans. Therefore, the objective of this 
study is to determine if isoflavones from drinking soy milk will scavenge RCS and lower the levels of RCS in 
humans. 
 
Are you qualified to be in this study? 
Inclusion Criteria 
1. Age 25-70 years 
2. BMI between 18 and 30 
3. Have no known allergy to soy milk 
4. Be not taking antibiotics for six months 
5. Be not currently taking medication 
a. No taking any prescription drugs 
 

b. If supplements were taken, flavonoid-enriched supplements (see list below) should be avoided. 
 
Major brands 
Notes 
Soy Isoflavones 
All flavonoid-enriched 
supplements should be 
avoided. 
Lipo-Flavonoid 
Citrus Bioflavonoids Complex 
Super Flavonoids 
Super Antioxidants 
Quercetin Supplement 
Essential-C and flavonoids 
Milk Thistle 
Other flavonoids supplements, including but not limited: Luteolin, Rutin, etc  
 
c. No any drugs or supplements within three weeks of the experiment 
6. Be nonsmoking 
7. Have no alcoholic intoxication 
a. No alcoholic addiction 
b. < 3-4 drinks per week (less than 2 glasses (300 mL) per drink) 
c. No alcohol within 3 three weeks of the experiment 
8. Have no extended exposure to industrial wastes 
 
Are there any reasons you should not be in this study? 
Exclusion Criteria 
1. Disease: gout, heart  disease, peripheral vascular disease, degenerative kidney, degenerative liver, 
diabetes, GI disorders, or endocrine disorders 
2. Cancer patients 
a. Currently diagnosed cancer patients will be excluded; 
b. Medication free for >2 years could be considered; 
 
How many people will take part in this study? 
There will be 16 people (8 males and 8 females) in this research study. 
 
How long will your part in this study last? 
You will be participating in a 3-week study. There will be 1 week of pre-washout period (from Day 1-7) and two 
weeks (Day 8-17) for sample collection. On Day 0, you need to come to the research facility and sign the Consent 
form and pick up the fecal collection kit. You will stay at the research facility for two entire days from 7:30 am 
to 4:30 pm on Day 8 and Day 15, respectively. On these two days, breakfast, lunch, and dinner will be provided. 
On Days 9, 10, 16, and 17, you need to drop off the urine and fecal samples at the Research facility. 
 
What is your food restriction during this study? 
First, make sure you do not have allergic reactions to soy milk consumption or you will be asked to quit.  
You will be asked not to drink any soy milk products and not take any medicines and supplements starting 1 week 
before the study and continuing throughout the entire study for a total of 3 weeks. In addition, you should follow 
the Food Restriction List below to avoid flavonoid-rich foods during the 3 weeks. It’s not allowed to eat restricted 
foods (in red). Also, you need to reduce to consume the limited foods (in yellow, no more than 1 serving per 
day). But you can eat the allowed foods (in green) as usual. We provide breakfast, lunch, and dinner for two days 
(days 8 and 15) when you stay at the research facility for blood drawing and urine sample collection.  
 
 
 
 
 

 
1. Restricted food 
 
 
Notes 
Soybeans and soy 
products 
Green soybeans 
Food Restricted 
 
Soy products(flour, fiber, meals, 
etc) 
Tofu 
Soy milk 
Soy cheese 
Fava beans 
Fruits 
Blackberries 
Food Restricted 
 
 
Cranberries 
Blueberries 
Raspberries 
Strawberries 
Grapes 
Oranges 
Cherries 
Apples 
Plum 
Vegetables 
Parsley 
Food restricted 
Cabbages 
Fruit  juice  
Orange juice 
Food Restricted 
 
Blackberry juice 
Cranberry juice 
Strawberry juice 
Grapefruit juice 
Lemon juice 
Lime juice  
V8 
Beverage 
Tea 
Food Restricted  
Foods that should be restricted are included but not limited to this table. Please be notified that all foods containing 
high levels of polyphenols/flavonoids (>100 mg per 100 g, fresh weight) should be avoided by participants.   
 
2. Limited food  
 
 
Notes: no more than 1 
serving per day 
Vegetables 
Eggplants 
Food limited 
Kales 
Asparagus 
Spinach 
Onions 
Purple sweet potatoes 
Nuts 
Almonds 
Food limited 
 
3. Allowed food  
 
 
Notes 
Eggs, meat, and dairy 
Eggs 
Food allowed 
Chicken meat 
Beef and pork 

Whole milk 
Cereal and cereal 
products 
Corn, barley, wheat 
Food allowed 
(Refined-grain products 
are recommended.) 
Pizza 
Noodles, pasta,  
Brown rice 
Spaghetti 
Fruits 
Avocados 
Food allowed 
Melons 
Peaches 
Pears 
Bananas 
Fruit  juice  
Crowberry juice 
Food allowed 
 
Grape juice 
Vegetables 
Green beans 
Food allowed 
Broccoli 
Peas 
Potatoes 
Sweet potatoes (except 
purple sweet potatoes)  
Corns 
Celery 
Leeks 
Lettuce 
Cucumber 
Tomatoes 
Beverage 
Coffee 
Food allowed 
Nuts 
Various nuts (except 
almonds) 
Food allowed  
 
 
What will happen if you take part in the study? 
All below mentioned procedures are a requirement for participation in the study. Regarding the study visit survey, 
you may choose not to answer a question for any reason. This is a crossover study. You will receive around 460 
ml of soy milk or regular milk with breakfast on Day 8 after 1 week of wash-out. Then on Day 15, you will receive 
regular milk or soy milk. 
 
§ Screen visit (Day 0): If you meet the initial inclusion criteria, you will report to the UNC Nutrition Research 
Institute in Kannapolis to meet with the study coordinator to determine study eligibility on day 0. After 
consenting, you will provide your age, height, and weight, then receive the food diary form to record what 
you eat during the entire study and a fecal sample collection kit.  
§ First visit (Day 8, whole day): After the wash-out from day 1 to 7, you will receive breakfast (sausage, egg, 
and cheese biscuit, or other breakfast made in the UNC-HRC kitchen) with a glass of unsweetened soy milk 
(around 460 ml) on day 8. You have 20 min to finish breakfast. Blood samples will be drawn through an 
indwelling needle at 0 (before breakfast), 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, and 8.0 h after breakfast (10 mL at 
each timepoint) by the UNC-HRC. An indwelling needle here refers to a peripheral venous catheter (PVC) 
that is placed into a peripheral vein on your arm (no needle left in the vein). Upon insertion, the line can be 
used to draw blood at different time points. Lunch will be provided by the UNC-HRC kitchen, and dinner will 
be prepared and can be taken back home. 
Also, the urine samples will be collected using plastic containers (provided by the researcher) at baseline 
(before breakfast), 0-2 h, 2-4 h, 4-6 h, and 6-8 h after breakfast during the stay at the Human Research Core 
at the UNC Nutrition Research Institute (UNC-HRC), and between 8-12 h and 12-24 h at home. Fecal samples 

will be collected at your convenience using the fecal collection kit (provided by the researcher) at baseline, 
24 h (Day 9), and 48 h (Day 10).  
§ Second visit (Day 9): The 24-h blood sample will be collected the next morning before breakfast (day 9). 
Also, you need to drop off the urine samples of 8-12 h and 12-24 h collected at home, and the fecal sample of 
24 h (Day 9). You will get the first payment after that.  
§ Third visit (Day 10): You just need to drop off the fecal sample of 48 h (day 10) at the research facility.  
§ Fourth visit (Day 15, whole day): On day 15, you will receive breakfast (the same size as the First visit) with 
regular milk (around 460 ml). The procedures of sample collection (blood, urine, and fecal samples) are the 
same as on Day 8.  
§ Fifth visit (Day 16): The 24-h blood sample will be collected the next morning before breakfast (day 16). 
Also, you need to drop off the urine samples of 8-12 h and 12-24 h collected at home, and the fecal sample of 
24 h (day 16). You will get the second payment after that.  
§ Sixth visit (Day 17): You just need to drop off the fecal sample of 48 h (day 17) at the research facility. 
§ Last visit: Preliminary test on plasma flavonoid contents will be completed within two weeks to make sure 
you follow the food restriction during the study. You will be notified to pick up the last payment if you 
pass the test. 
 
What are the possible benefits of being in this study? 
Research is designed to benefit society by gaining new knowledge. Also, results generated from this project may 
benefit the general public including participants in this project on the health effects of flavonoid-rich foods. There 
are no known personal benefits for participating in this study. 
 
What are the possible risks or discomforts involved in being in this study? 
There are no major risks associated with the study intervention of soy milk. However, soy consumption may cause 
some mild stomach and intestinal side effects such as constipation, bloating, and nausea. It may also cause allergic 
reactions involving a rash, itching, and breathing problems in some people. So, please make sure you have no 
known allergy to soy milk. If you experience nausea, vomiting or diarrhea, or fevers, you may contact your 
medical provider and let them know. 
 
Possible risks involved in drawing blood from a vein may mild momentary discomfort at the site of the blood 
draw, possible mild bruising, redness, and mild swelling around the site, minimal bleeding at the site, mild feeling 
of lightheadedness when the blood is drawn, and rarely, an infection at the site of the blood draw. There may be 
uncommon or previously unknown risks. You should report any problems to the researcher. In addition, it is 
possible that participants may feel a little embarrassed about the collection of urine and stool samples. 
 
What if we learn about new findings or information during the study? 
You will be given any new information gained during the course of the study that might affect your willingness 
to continue participation. 
 
How will information about you be protected? 
All participants will be assigned an ID number, which is used for identification purposes throughout the study. 
Participant data will be stored on a password-protected university computer, that will be kept locked in the 
coordinator’s office. No data will be placed on any network. The plasma, urine, and fecal samples will be stored 
in the -80°C freezer and will be labeled with an identifying number. Participants will not be identified in any 
report or publication about this study. Although every effort will be made to keep research records private, there 
may be times when federal or state law requires the disclosure of such records, including personal information. 
This is very unlikely, but if the disclosure is ever required, NC A&T State University will take steps allowable 
by law to protect the privacy of personal information. In some cases, your information in this research study could 
be reviewed by representatives of the University, research sponsors, or government agencies for purposes such 
as quality control or safety. 
 
What if you want to stop before your part in the study is complete? 

You can withdraw from this study at any time, without penalty. The investigators also have the right to stop your 
participation at any time. This could be because you have had an unexpected reaction, or have failed to follow 
the instructions (for example, failed to follow the food restriction during the study), or because the entire study 
has been stopped. 
 
Will you receive anything for being in this study? 
You will be receiving gift card incentives for taking part in this study. The incentives will be split into three parts 
($100, $150, and $150) and received depending on the completeness of the study. $100 gift card will be received 
on the third visit (24 h blood collection after the first arm). Another $150 gift card will be received by the 6th visit 
(24h blood collection after the second arm). The last payment of $150 gift card will be ready to pick up on the 8th 
visit (after the preliminary test of plasma flavonoid levels for the food restriction). [1st visit, interview and consent 
form, food diary form for prewash out. 2nd visit, breakfast, blood, urine; 3rd visit, 24h blood drawing, urine sample, 
and fecal samples drop off. 4th visit, 48h fecal samples drop off. 5th visit, breakfast, blood, urine, and fecal samples. 
6th visit, 24h blood drawing, urine sample, and fecal samples drop off. 7th visit, 48h fecal samples drop off. 8th 
visit, after the preliminary test.] 
 
Will it cost you anything to be in this study? 
It will not cost you anything to be in this study. 
 
What if you are a NCA&T student or employee? 
Taking part in this research is not a part of your University duties and refusing will not affect your class standing 
or grades, or your job. You will not be offered or receive any special consideration if you take part in this research. 
 
What will happen if you are injured by this research? 
All research involved a chance that something bad might happen to you. If you are hurt, become sick, or develop 
a reaction from something that was done as part of this study, the researcher will help you get medical care, but 
the North Carolina A&T State Univeristy and NIH have not set aside funds to pay you for any such injuries, 
illness or reactions, or for the related medical care. Adverse events will be reported to the IRB within 72 hours. 
When medical attention is needed, 911 will be promptly called.     
 
Who is sponsoring this study? 
This research is funded by NIH (NIDDK). If you would like more information, please ask the researchers listed 
on the first page of this form. 
 
What if you have questions about this study? 
You have the right to ask and have answered, any questions you may have about this research. If you have 
questions about the study (including payments), complaints, or concerns, or if a research-related injury occurs, 
you should contact the researchers listed on the first page of this form. 
 
A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S. Law. This 
website will not include information that can identify you. At most, the website will include a summary of the 
results. You can search this website at any time. 
 
The study results will be published in a scientific journal. You can search for it at any time after it is published. 
 
What if you have any questions about your rights as a research participant? 
All research on human volunteers is reviewed by a committee that works to protect your rights and welfare. If 
you have questions or concerns about your rights as a research subject, or if you would like to obtain information 
or offer input, you may contact the Institutional Review Board (IRB) at 336-334-7995 or by email at 
rescomp@ncat.edu.  
 
Will I be contacted in the future? 

If you choose, you may be contacted for future studies. 
 
Do you consent to be contacted for future studies? Y        N 
 
 
 
Participant’s Agreement: 
 
I have read the information provided above. I have asked all the questions I have at this time. I also confirm that 
I do not have an allergy to soy milk intake. I voluntarily agree to participate in this research study. 
 
 
 
 
Signature of Research Participant                                                   Date  
 
 
Printed Name of Research Participant 
 
 
 
Signature of Research Team Member Obtaining Consent             Date  
 
 
Printed Name of Research Team Member Obtaining Consent