CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 165 enrolled
Drug / intervention
Placebo +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00951912
NCT00951912N/ACompleted

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

Sun Yat-sen University·interventional·Posted Aug 4, 2009·Updated Oct 17, 2012

In Brief

A clinical study evaluating Placebo, Daidzein, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 165 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 4, 2009
Enrollment StartAug 1, 2009
Primary CompletionJun 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.9 years ago

Interventions

Placebodietary

10g soy protein isolated per day

Daidzeindietary

50mg daidzein +10g soy protein isolated per day

Genisteindietary

50mg genistein +10g soy protein isolated per day