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Completed

NCT Number: NCT00951912

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

10g soy protein isolated per day

Daidzein

Dietary Supplement

50mg daidzein +10g soy protein isolated per day

Genistein

Dietary Supplement

50mg genistein +10g soy protein isolated per day

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Chinese Nutrition Society
  • Danone Institute International
  • Department of Health of Guangdong Province

Registry information

Official study title

The Study of the Effects of Soy Isoflavones on the Metabolism of Glucose and Lipids in Postmenopausal Chinese Women With Impaired Glucose Regulation

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 4, 2009
Registry last updated
Oct 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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