The Effects of Soy Isoflavones to Improve the Metabolism of Glucose and Lipids
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus |
Dietary Supplement: Placebo Dietary Supplement: Daidzein Dietary Supplement: Genistein |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
- Percentage Change in Fasting Plasma Glucose [ Time Frame: Baseline,6 months ] [ Designated as safety issue: No ](6th month value-baseline value)/baseline value*100%
- Percentage Change in 120-minutes Postload Plasma Glucose [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ](6th month value-baseline value)/baseline*100%
- Percentage Change in HbA1C [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ](6th month value-baseline value)/baseline value*100%
- Percentage Change in AUC of Glucose [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ](6th month value-baseline value)/baseline value*100%
- Percentage Change in HOMA-IR [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ](6th month value-baseline value)/baseline value*100%
- Percentage Change in Triglyceride [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ](6th month value-baseline value)/baseline value*100%
- Percentage Change in High Density Lipoprotein Cholesterol [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ](6th month value-baseline value)/baseline value*100%
- Percentage Change in Low Density Lipoprotein Cholesterol [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ](6th month value-baseline value)/baseline value*100%
- Total Urinary Isoflavones [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Urinary Daidzein [ Time Frame: 3 months ] [ Designated as safety issue: No ]Urinary daidzein excretion
- Urinary Genistein [ Time Frame: 3 months ] [ Designated as safety issue: No ]Urinary genistein excretion
- Total Energy Intake at Follow-up [ Time Frame: an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week. ] [ Designated as safety issue: No ]The energy intake was evaluated by 3 days dietary records.
| Enrollment: | 165 |
| Study Start Date: | August 2009 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
10g soy protein isolated powder patch by mouth everyday for 6months
|
Dietary Supplement: Placebo
10g soy protein isolated per day
|
|
Experimental: Daidzein
10g soy protein isolated plus 50mg daidzein powder patch by mouth everyday for 6 months
|
Dietary Supplement: Daidzein
50mg daidzein +10g soy protein isolated per day
|
|
Experimental: Genistein
10g soy protein isolated plus 50mg genistein powder patch by mouth everyday for 6 months
|
Dietary Supplement: Genistein
50mg genistein +10g soy protein isolated per day
|
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| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| China, Guangdong | |
| The First Affiliated Hospital, Sun Yat-sen University | |
| Guangzhou, Guangdong, China, 510080 | |
| Principal Investigator: | Yan-bin Ye, MD | Sun Yat-sen University |
| Study Director: | Yu-ming Chen, PhD | Sun Yat-sen University |
More Information
No publications provided
| Responsible Party: | yanbinye, Associate professor, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT00951912 History of Changes |
| Other Study ID Numbers: | yanbinye |
| Study First Received: | August 3, 2009 |
| Results First Received: | June 26, 2012 |
| Last Updated: | October 16, 2012 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Sun Yat-sen University:
|
genistein daidzein impaired glucose regulation glucose metabolism |
lipids metabolism inflammation women |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Daidzein Genistein Phytoestrogens Estrogens, Non-Steroidal Estrogens Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anticarcinogenic Agents Protective Agents Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013