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

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

Sponsors

Lead sponsor: Sun Yat-sen University

Collaborator: Chinese Nutrition Society
Danone Institute International
Department of Health of Guangdong Province

Source Sun Yat-sen University
Brief Summary

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

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.

Overall Status Completed
Start Date August 2009
Completion Date September 2011
Primary Completion Date June 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage Change in Fasting Plasma Glucose Baseline,6 months
Percentage Change in 120-minutes Postload Plasma Glucose Baseline, 6 months
Percentage Change in HbA1C Baseline, 6 months
Percentage Change in AUC of Glucose Baseline, 6 months
Percentage Change in Fasting Plasma Insulin Baseline, 6 months
Percentage Change in HOMA-IR Baseline, 6 months
Percentage Change in QUICKI Baseline, 6 months
Percentage Change in Total Cholesterol Baseline, 6 months
Percentage Change in Triglyceride Baseline, 6 months
Percentage Change in High Density Lipoprotein Cholesterol Baseline, 6 months
Percentage Change in Low Density Lipoprotein Cholesterol Baseline, 6 months
Secondary Outcome
Measure Time Frame
Total Urinary Isoflavones 3 months
Urinary Daidzein 3 months
Urinary Genistein 3 months
Total Energy Intake at Follow-up an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week.
Enrollment 165
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Placebo

Description: 10g soy protein isolated per day

Arm group label: Placebo

Intervention type: Dietary Supplement

Intervention name: Daidzein

Description: 50mg daidzein +10g soy protein isolated per day

Arm group label: Daidzein

Intervention type: Dietary Supplement

Intervention name: Genistein

Description: 50mg genistein +10g soy protein isolated per day

Arm group label: Genistein

Eligibility

Criteria:

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

Gender: Female

Minimum age: 30 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Location
facility The First Affiliated Hospital, Sun Yat-sen University
Location Countries

China

Verification Date

October 2012

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Sun Yat-sen University

Investigator full name: yanbinye

Investigator title: Associate professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: 10g soy protein isolated powder patch by mouth everyday for 6months

Arm group label: Daidzein

Arm group type: Experimental

Description: 10g soy protein isolated plus 50mg daidzein powder patch by mouth everyday for 6 months

Arm group label: Genistein

Arm group type: Experimental

Description: 10g soy protein isolated plus 50mg genistein powder patch by mouth everyday for 6 months

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov