The Effects of Soy Isoflavones to Improve the Metabolism of Glucose and Lipids

Study Overview
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Brief Summary
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Many studies showed that soy foods or soy isoflavones can lower the risk of cardiovascular disease (CVD), osteoporosis and some cancers, but few human studies assessed effects of purified isoflavone components (genistein and daidzein) on glucose metabolism. This double-blinded, randomized, placebo-controlled trial will examine the effects of purified genistein and daidzein on glucose metabolism in prediabetic or diabetic women. One hundred and eighty eligible women age 30-70 years(without any treatment of diabetic drugs) will be recruited and randomly allocated into the following three arms: Placebo (10g isolated soy protein, ISP); Genistein (10g ISP + 50mg genistein); Daidzein (10g ISP + 50mg daidzein) per day for 6 mo. Fasting glucose, lipids, insulin, inflammation marks and post-load for glucose and insulin will be determined at 0, 3th, and 6th month. Changes in these indices will be compared among the three groups.

Detailed Description
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Subjects were Chinese adult women, age 30-70 year, with an FG concentration ranging from 5.6 to 7.0 mmol/L or 2-h PG concentration ranging from 7.8-11.0 mmol/L or with newly diagnosed diabetes not requiring medication treatment according to a doctor's suggestion or participants did not willing to take medication themselves, and managed their diabetes just with a stable diet and exercise. Women were excluded if they had a history of coronary heart disease, stoke, thyroid disease, severe liver, lung, or gastrointestinal tract diseases; were currently or in the past 8 weeks used hypoglycemic or lipid-lowering or weight-reduction agents; were occurrence of diabetic complications; use of hormone replacement therapy; allergy to soy;were long-term antibiotics users.

Official Title
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The Study of the Effects of Soy Isoflavones on the Metabolism of Glucose and Lipids in Postmenopausal Chinese Women With Impaired Glucose Regulation

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Daidzein
* Dietary Supplement: Genistein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chinese women aged 30-70 y Fasting glucose >=5.6 mmol/l; post-load glucose >=7.8 mmol/l Exclusion Criteria: Diabetes renal diseases Confirmed CVD, chronic liver,kidney diseases,Thyroid disease Medications affecting glucose or lipid metabolism

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>10g soy protein isolated powder patch by mouth everyday for 6months | Dietary Supplement: Placebo<br>* 10g soy protein isolated per day<br>|
| Experimental: Daidzein<br>10g soy protein isolated plus 50mg daidzein powder patch by mouth everyday for 6 months | Dietary Supplement: Daidzein<br>* 50mg daidzein +10g soy protein isolated per day<br>|
| Experimental: Genistein<br>10g soy protein isolated plus 50mg genistein powder patch by mouth everyday for 6 months | Dietary Supplement: Genistein<br>* 50mg genistein +10g soy protein isolated per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Fasting Plasma Glucose | (6th month value-baseline value)/baseline value*100% | Baseline,6 months | 
| Percentage Change in 120-minutes Postload Plasma Glucose | (6th month value-baseline value)/baseline*100% | Baseline, 6 months | 
| Percentage Change in HbA1C | (6th month value-baseline value)/baseline value*100% | Baseline, 6 months | 
| Percentage Change in AUC of Glucose | values were from 75g glucose oral glucose tolerance test and caculated as (6th month value-baseline value)/baseline value*100% | Baseline, 6 months | 
| Percentage Change in Fasting Plasma Insulin | (6th month value-baseline value)/baseline value*100% | Baseline, 6 months | 
| Percentage Change in HOMA-IR | HOMA-IR was calculated with the homeostasis model assessment for insulin resistance,and it is caculated as the following equation: HOMA-IR=FIns×FG/22.5, where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value*100% | Baseline, 6 months | 
| Percentage Change in QUICKI | QUICKI is the abbreviation of Quantitative Insulin Sensitivity Check Index,and it is a marker to evaluate insulin sensitivity in HOMA model.It is calculated by using the following equation: 1/(logFIns +logFG),where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value*100% | Baseline, 6 months | 
| Percentage Change in Total Cholesterol | (6th month value-baseline value)/baseline value*100% | Baseline, 6 months | 
| Percentage Change in Triglyceride | (6th month value-baseline value)/baseline value*100% | Baseline, 6 months | 
| Percentage Change in High Density Lipoprotein Cholesterol | (6th month value-baseline value)/baseline value*100% | Baseline, 6 months | 
| Percentage Change in Low Density Lipoprotein Cholesterol | (6th month value-baseline value)/baseline value*100% | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Urinary Isoflavones |  | 3 months | 
| Urinary Daidzein | Urinary daidzein excretion | 3 months | 
| Urinary Genistein | Urinary genistein excretion | 3 months | 
| Total Energy Intake at Follow-up | The energy intake was evaluated by 3 days dietary records. | an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genistein, daidzein, impaired glucose regulation, glucose metabolism, lipids metabolism, inflammation, women