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The Effects of Soy Protein and Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors

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ClinicalTrials.gov Identifier: NCT00856882
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : March 6, 2009
Sponsor:
Information provided by:
Chinese University of Hong Kong

Brief Summary:
The investigators propose to perform a double-blind, randomized placebo-controlled trial to examine the hypothesis that soy protein with isoflavones could improve glycemic control, insulin sensitivity and decrease cardiovascular risk factors in postmenopausal women with prediabetes.

Condition or disease Intervention/treatment
Diabetes Cardiovascular Risk Dietary Supplement: soy protein Dietary Supplement: isoflavones Dietary Supplement: milk protein

Study Type : Interventional  (Clinical Trial)
Official Title: The Effects of Soy Protein and/or Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors-a Six Months RCT Among Postmenopausal Women
Study Start Date : October 2007
Primary Completion Date : April 2008

Arm Intervention/treatment
Experimental: soy protein and isoflavones Dietary Supplement: soy protein Dietary Supplement: isoflavones
Experimental: milk protein and isoflavones Dietary Supplement: isoflavones Dietary Supplement: milk protein
Placebo Comparator: milk protein only Dietary Supplement: milk protein




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Ages Eligible for Study:   46 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hong Kong Chinese menopausal women aged 46-70 years with prediabetes or early untreated diabetes

Exclusion Criteria:

  • Women with breast, ovary or other cancers in recent 5-year
  • Severe renal or liver dysfunction
  • Women with androgen excess
  • Smokers
  • Current use or recent (3-month)use of any drug or treatment for glycemic control, lipid improvement, weight reduction; Subjects with known soy or milk allergy.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00856882     History of Changes
Other Study ID Numbers: CUHK4450/06M
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: March 6, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs