We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00856882
First Posted: March 6, 2009
Last Update Posted: March 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chinese University of Hong Kong
  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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

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 Submitted: March 5, 2009
First Posted: March 6, 2009
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