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

This study has been completed.

First Received: March 5, 2009 No Changes Posted

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00856882

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:

MedlinePlus related topics: Dietary Supplements Diets

Drug Information available for: Insulin Proteins, soy

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
soy protein and isoflavones: Experimental	Dietary Supplement: soy protein Dietary Supplement: isoflavones
milk protein and isoflavones: Experimental	Dietary Supplement: isoflavones Dietary Supplement: milk protein
milk protein only: Placebo Comparator	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

Study ID Numbers:	CUHK4450/06M
Study First Received:	March 5, 2009
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00856882 History of Changes
Health Authority:	Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study placed in the following topic categories:

Diabetes Mellitus
Insulin

ClinicalTrials.gov processed this record on September 10, 2009