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

October 16, 2012 updated by: yanbinye, Sun Yat-sen University

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

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 Overview

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.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
10g soy protein isolated powder patch by mouth everyday for 6months
10g soy protein isolated per day
EXPERIMENTAL: Daidzein
10g soy protein isolated plus 50mg daidzein powder patch by mouth everyday for 6 months
50mg daidzein +10g soy protein isolated per day
EXPERIMENTAL: Genistein
10g soy protein isolated plus 50mg genistein powder patch by mouth everyday for 6 months
50mg genistein +10g soy protein isolated per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change in Fasting Plasma Glucose
Time Frame: Baseline,6 months
(6th month value-baseline value)/baseline value*100%
Baseline,6 months
Percentage Change in 120-minutes Postload Plasma Glucose
Time Frame: Baseline, 6 months
(6th month value-baseline value)/baseline*100%
Baseline, 6 months
Percentage Change in HbA1C
Time Frame: Baseline, 6 months
(6th month value-baseline value)/baseline value*100%
Baseline, 6 months
Percentage Change in AUC of Glucose
Time Frame: Baseline, 6 months
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
Time Frame: Baseline, 6 months
(6th month value-baseline value)/baseline value*100%
Baseline, 6 months
Percentage Change in HOMA-IR
Time Frame: Baseline, 6 months
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
Time Frame: Baseline, 6 months

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
Time Frame: Baseline, 6 months
(6th month value-baseline value)/baseline value*100%
Baseline, 6 months
Percentage Change in Triglyceride
Time Frame: Baseline, 6 months
(6th month value-baseline value)/baseline value*100%
Baseline, 6 months
Percentage Change in High Density Lipoprotein Cholesterol
Time Frame: Baseline, 6 months
(6th month value-baseline value)/baseline value*100%
Baseline, 6 months
Percentage Change in Low Density Lipoprotein Cholesterol
Time Frame: Baseline, 6 months
(6th month value-baseline value)/baseline value*100%
Baseline, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Urinary Isoflavones
Time Frame: 3 months
3 months
Urinary Daidzein
Time Frame: 3 months
Urinary daidzein excretion
3 months
Urinary Genistein
Time Frame: 3 months
Urinary genistein excretion
3 months
Total Energy Intake at Follow-up
Time Frame: an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yan-bin Ye, MD, Sun Yat-sen University
  • Study Director: Yu-ming Chen, PhD, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

August 3, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (ESTIMATE)

August 4, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 17, 2012

Last Update Submitted That Met QC Criteria

October 16, 2012

Last Verified

October 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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