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

This study has been completed.
Sponsor:
Collaborators:
Chinese Nutrition Society
Danone Institute International
Department of Health of Guangdong Province
Information provided by (Responsible Party):
yanbinye, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00951912
First received: August 3, 2009
Last updated: October 16, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • 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%


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Daidzein
Genistein
Anticarcinogenic Agents
Antineoplastic Agents
Enzyme Inhibitors
Estrogens
Estrogens, Non-Steroidal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Phytoestrogens
Protective Agents
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014