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

NCT00951912 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2012-10-17

Study results available
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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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Placebo

10g soy protein isolated per day

DIETARY_SUPPLEMENT

Daidzein

50mg daidzein +10g soy protein isolated per day

DIETARY_SUPPLEMENT

Genistein

50mg genistein +10g soy protein isolated per day

Sponsors & Collaborators

  • Chinese Nutrition Society

    collaborator UNKNOWN

  • Danone Institute International

    collaborator OTHER

  • Department of Health of Guangdong Province

    collaborator UNKNOWN

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yan-bin Ye, MD · Sun Yat-sen University

  • Yu-ming Chen, PhD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-06-30
Completion
2011-09-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00951912 on ClinicalTrials.gov