Clinical trial NCT00951912: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: genistein
daidzein
impaired glucose regulation
glucose metabolism
lipids metabolism
inflammation
women
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Chinese Nutrition Society
name: Danone Institute International
name: Department of Health of Guangdong Province
First posted: 2009-08-04
Enrollment: 165
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Percentage Change in Fasting Plasma Glucose
timeFrame: Baseline,6 months
measure: Percentage Change in 120-minutes Postload Plasma Glucose
timeFrame: Baseline, 6 months
measure: Percentage Change in HbA1C
timeFrame: Baseline, 6 months
measure: Percentage Change in AUC of Glucose
timeFrame: Baseline, 6 months
measure: Percentage Change in Fasting Plasma Insulin
timeFrame: Baseline, 6 months
measure: Percentage Change in HOMA-IR
timeFrame: Baseline, 6 months
measure: Percentage Change in QUICKI
timeFrame: Baseline, 6 months
measure: Percentage Change in Total Cholesterol
timeFrame: Baseline, 6 months
measure: Percentage Change in Triglyceride
timeFrame: Baseline, 6 months
measure: Percentage Change in High Density Lipoprotein Cholesterol
timeFrame: Baseline, 6 months
measure: Percentage Change in Low Density Lipoprotein Cholesterol
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Total Urinary Isoflavones
timeFrame: 3 months
measure: Urinary Daidzein
timeFrame: 3 months
measure: Urinary Genistein
timeFrame: 3 months
measure: Total Energy Intake at Follow-up
timeFrame: an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yan-bin Ye, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-sen University
name: Yu-ming Chen, PhD
role: STUDY_DIRECTOR
References: