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

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00856882
First received: March 5, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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 Intervention
Diabetes
Cardiovascular Risk
 Dietary Supplement: soy protein
Dietary Supplement: isoflavones
Dietary Supplement: milk protein

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Study Start Date: October 2007
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   46 Years to 70 Years
Genders 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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Chinese University of Hong Kong

Additional 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
Study First Received: March 5, 2009
Last Updated: March 5, 2009
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013