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

Sun Yat-sen University

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: Genistein; Dietary Supplement: Daidzein; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00951912

yanbinye

Details and patient eligibility

About

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.

Full 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.

Enrollment: 165 patients

Sex: Female

Ages: 30 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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165 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Daidzein

Experimental group

Description:

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

Treatment:

Dietary Supplement: Daidzein

Genistein

Experimental group

Description:

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

Treatment:

Dietary Supplement: Genistein