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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Placebo
Daidzein
Genistein
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring genistein, daidzein, impaired glucose regulation, glucose metabolism, lipids metabolism, inflammation, women

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Daidzein

Genistein

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Percentage Change in Fasting Plasma Glucose
(6th month value-baseline value)/baseline value*100%
Percentage Change in 120-minutes Postload Plasma Glucose
(6th month value-baseline value)/baseline*100%
Percentage Change in HbA1C
(6th month value-baseline value)/baseline value*100%
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%
Percentage Change in Fasting Plasma Insulin
(6th month value-baseline value)/baseline value*100%
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%
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%
Percentage Change in Total Cholesterol
(6th month value-baseline value)/baseline value*100%
Percentage Change in Triglyceride
(6th month value-baseline value)/baseline value*100%
Percentage Change in High Density Lipoprotein Cholesterol
(6th month value-baseline value)/baseline value*100%
Percentage Change in Low Density Lipoprotein Cholesterol
(6th month value-baseline value)/baseline value*100%

Secondary Outcome Measures

Total Urinary Isoflavones
Urinary Daidzein
Urinary daidzein excretion
Urinary Genistein
Urinary genistein excretion
Total Energy Intake at Follow-up
The energy intake was evaluated by 3 days dietary records.

Full Information

First Posted
August 3, 2009
Last Updated
October 16, 2012
Sponsor
Sun Yat-sen University
Collaborators
Chinese Nutrition Society, Danone Institute International, Department of Health of Guangdong Province
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1. Study Identification

Unique Protocol Identification Number
NCT00951912
Brief Title
The Effects of Soy Isoflavones to Improve the Metabolism of Glucose and Lipids
Official Title
The Study of the Effects of Soy Isoflavones on the Metabolism of Glucose and Lipids in Postmenopausal Chinese Women With Impaired Glucose Regulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Chinese Nutrition Society, Danone Institute International, Department of Health of Guangdong Province

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
genistein, daidzein, impaired glucose regulation, glucose metabolism, lipids metabolism, inflammation, women

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
10g soy protein isolated powder patch by mouth everyday for 6months
Arm Title
Daidzein
Arm Type
Experimental
Arm Description
10g soy protein isolated plus 50mg daidzein powder patch by mouth everyday for 6 months
Arm Title
Genistein
Arm Type
Experimental
Arm Description
10g soy protein isolated plus 50mg genistein powder patch by mouth everyday for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
10g soy protein isolated per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Daidzein
Intervention Description
50mg daidzein +10g soy protein isolated per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Genistein
Intervention Description
50mg genistein +10g soy protein isolated per day
Primary Outcome Measure Information:
Title
Percentage Change in Fasting Plasma Glucose
Description
(6th month value-baseline value)/baseline value*100%
Time Frame
Baseline,6 months
Title
Percentage Change in 120-minutes Postload Plasma Glucose
Description
(6th month value-baseline value)/baseline*100%
Time Frame
Baseline, 6 months
Title
Percentage Change in HbA1C
Description
(6th month value-baseline value)/baseline value*100%
Time Frame
Baseline, 6 months
Title
Percentage Change in AUC of Glucose
Description
values were from 75g glucose oral glucose tolerance test and caculated as (6th month value-baseline value)/baseline value*100%
Time Frame
Baseline, 6 months
Title
Percentage Change in Fasting Plasma Insulin
Description
(6th month value-baseline value)/baseline value*100%
Time Frame
Baseline, 6 months
Title
Percentage Change in HOMA-IR
Description
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%
Time Frame
Baseline, 6 months
Title
Percentage Change in QUICKI
Description
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%
Time Frame
Baseline, 6 months
Title
Percentage Change in Total Cholesterol
Description
(6th month value-baseline value)/baseline value*100%
Time Frame
Baseline, 6 months
Title
Percentage Change in Triglyceride
Description
(6th month value-baseline value)/baseline value*100%
Time Frame
Baseline, 6 months
Title
Percentage Change in High Density Lipoprotein Cholesterol
Description
(6th month value-baseline value)/baseline value*100%
Time Frame
Baseline, 6 months
Title
Percentage Change in Low Density Lipoprotein Cholesterol
Description
(6th month value-baseline value)/baseline value*100%
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Total Urinary Isoflavones
Time Frame
3 months
Title
Urinary Daidzein
Description
Urinary daidzein excretion
Time Frame
3 months
Title
Urinary Genistein
Description
Urinary genistein excretion
Time Frame
3 months
Title
Total Energy Intake at Follow-up
Description
The energy intake was evaluated by 3 days dietary records.
Time Frame
an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan-bin Ye, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yu-ming Chen, PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

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

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