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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951912
• Other study ID #: yanbinye
• Status: Completed
• Phase: N/A
• First received: August 3, 2009
• Last updated: October 16, 2012
• Start date: August 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2012
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Placebo
10g soy protein isolated per day
• Daidzein
50mg daidzein +10g soy protein isolated per day
• Genistein
50mg genistein +10g soy protein isolated per day

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Sun Yat-sen University	Chinese Nutrition Society, Danone Institute International, Department of Health of Guangdong Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change in Fasting Plasma Glucose	(6th month value-baseline value)/baseline value*100%	Baseline,6 months	No
Primary	Percentage Change in 120-minutes Postload Plasma Glucose	(6th month value-baseline value)/baseline*100%	Baseline, 6 months	No
Primary	Percentage Change in HbA1C	(6th month value-baseline value)/baseline value*100%	Baseline, 6 months	No
Primary	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%	Baseline, 6 months	No
Primary	Percentage Change in Fasting Plasma Insulin	(6th month value-baseline value)/baseline value*100%	Baseline, 6 months	No
Primary	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%	Baseline, 6 months	No
Primary	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%	Baseline, 6 months	No
Primary	Percentage Change in Total Cholesterol	(6th month value-baseline value)/baseline value*100%	Baseline, 6 months	No
Primary	Percentage Change in Triglyceride	(6th month value-baseline value)/baseline value*100%	Baseline, 6 months	No
Primary	Percentage Change in High Density Lipoprotein Cholesterol	(6th month value-baseline value)/baseline value*100%	Baseline, 6 months	No
Primary	Percentage Change in Low Density Lipoprotein Cholesterol	(6th month value-baseline value)/baseline value*100%	Baseline, 6 months	No
Secondary	Total Urinary Isoflavones		3 months	No
Secondary	Urinary Daidzein	Urinary daidzein excretion	3 months	No
Secondary	Urinary Genistein	Urinary genistein excretion	3 months	No
Secondary	Total Energy Intake at Follow-up	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.	No