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

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ClinicalTrials.gov Identifier: NCT00951912
Recruitment Status : Completed
First Posted : August 4, 2009
Results First Posted : October 16, 2012
Last Update Posted : October 17, 2012
Sponsor:
Collaborators:
Chinese Nutrition Society
Danone Institute International
Department of Health of Guangdong Province
Information provided by (Responsible Party):
yanbinye, 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dietary Supplement: Placebo Dietary Supplement: Daidzein Dietary Supplement: Genistein Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Genistein
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Percentage Change in Fasting Plasma Glucose [ Time Frame: Baseline,6 months ]
    (6th month value-baseline value)/baseline value*100%

  2. Percentage Change in 120-minutes Postload Plasma Glucose [ Time Frame: Baseline, 6 months ]
    (6th month value-baseline value)/baseline*100%

  3. Percentage Change in HbA1C [ Time Frame: Baseline, 6 months ]
    (6th month value-baseline value)/baseline value*100%

  4. Percentage Change in AUC of Glucose [ Time Frame: Baseline, 6 months ]
    values were from 75g glucose oral glucose tolerance test and caculated as (6th month value-baseline value)/baseline value*100%

  5. Percentage Change in Fasting Plasma Insulin [ Time Frame: Baseline, 6 months ]
    (6th month value-baseline value)/baseline value*100%

  6. Percentage Change in HOMA-IR [ Time Frame: 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%

  7. Percentage Change in QUICKI [ Time Frame: 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%


  8. Percentage Change in Total Cholesterol [ Time Frame: Baseline, 6 months ]
    (6th month value-baseline value)/baseline value*100%

  9. Percentage Change in Triglyceride [ Time Frame: Baseline, 6 months ]
    (6th month value-baseline value)/baseline value*100%

  10. Percentage Change in High Density Lipoprotein Cholesterol [ Time Frame: Baseline, 6 months ]
    (6th month value-baseline value)/baseline value*100%

  11. Percentage Change in Low Density Lipoprotein Cholesterol [ Time Frame: Baseline, 6 months ]
    (6th month value-baseline value)/baseline value*100%


Secondary Outcome Measures :
  1. Total Urinary Isoflavones [ Time Frame: 3 months ]
  2. Urinary Daidzein [ Time Frame: 3 months ]
    Urinary daidzein excretion

  3. Urinary Genistein [ Time Frame: 3 months ]
    Urinary genistein excretion

  4. 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. ]
    The energy intake was evaluated by 3 days dietary records.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00951912


Locations
China, Guangdong
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Chinese Nutrition Society
Danone Institute International
Department of Health of Guangdong Province
Investigators
Principal Investigator: Yan-bin Ye, MD Sun Yat-sen University
Study Director: Yu-ming Chen, PhD Sun Yat-sen University

Responsible Party: yanbinye, Associate professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00951912     History of Changes
Other Study ID Numbers: yanbinye
First Posted: August 4, 2009    Key Record Dates
Results First Posted: October 16, 2012
Last Update Posted: October 17, 2012
Last Verified: October 2012

Keywords provided by yanbinye, 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
Genistein
Daidzein
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists