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

Not Applicable

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Dietary Supplement: Placebo
Dietary Supplement: Daidzein
Dietary Supplement: Genistein

Registration Number: NCT00951912

Lead Sponsor: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 165

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	10g soy protein isolated powder patch by mouth everyday for 6months
Daidzein	Daidzein	10g soy protein isolated plus 50mg daidzein powder patch by mouth everyday for 6 months
Genistein	Genistein	10g soy protein isolated plus 50mg genistein powder patch by mouth everyday for 6 months

Primary Outcome Measures

Name	Time	Method
Percentage Change in High Density Lipoprotein Cholesterol	Baseline, 6 months	(6th month value-baseline value)/baseline value\*100%
Percentage Change in Fasting Plasma Glucose	Baseline,6 months	(6th month value-baseline value)/baseline value\*100%
Percentage Change in 120-minutes Postload Plasma Glucose	Baseline, 6 months	(6th month value-baseline value)/baseline\*100%
Percentage Change in HbA1C	Baseline, 6 months	(6th month value-baseline value)/baseline value\*100%
Percentage Change in AUC of Glucose	Baseline, 6 months	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	Baseline, 6 months	(6th month value-baseline value)/baseline value\*100%
Percentage Change in HOMA-IR	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%
Percentage Change in QUICKI	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%
Percentage Change in Total Cholesterol	Baseline, 6 months	(6th month value-baseline value)/baseline value\*100%
Percentage Change in Triglyceride	Baseline, 6 months	(6th month value-baseline value)/baseline value\*100%
Percentage Change in Low Density Lipoprotein Cholesterol	Baseline, 6 months	(6th month value-baseline value)/baseline value\*100%

Secondary Outcome Measures

Name	Time	Method
Total Urinary Isoflavones	3 months
Urinary Daidzein	3 months	Urinary daidzein excretion
Urinary Genistein	3 months	Urinary genistein excretion
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.	The energy intake was evaluated by 3 days dietary records.