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

Tracking Information
First Received Date ^ICMJE	March 5, 2009
Last Updated Date	March 5, 2009
Start Date ^ICMJE	October 2007
Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effects of Soy Protein and Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors
Official Title ^ICMJE	The Effects of Soy Protein and/or Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors-a Six Months RCT Among Postmenopausal Women
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Diabetes Cardiovascular Risk
Intervention ^ICMJE	Dietary Supplement: soy protein Dietary Supplement: isoflavones Dietary Supplement: milk protein
Study Arm (s)	Experimental: soy protein and isoflavones Interventions: Dietary Supplement: soy protein Dietary Supplement: isoflavones Experimental: milk protein and isoflavones Interventions: Dietary Supplement: isoflavones Dietary Supplement: milk protein Placebo Comparator: milk protein only Intervention: Dietary Supplement: milk protein
Publications *	Liu ZM, Ho SC, Chen YM, Ho YP. A mild favorable effect of soy protein with isoflavones on body composition--a 6-month double-blind randomized placebo-controlled trial among Chinese postmenopausal women. Int J Obes (Lond). 2010 Feb;34(2):309-18. Epub 2009 Nov 17.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	April 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	46 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00856882
Other Study ID Numbers ^ICMJE	CUHK4450/06M
Has Data Monitoring Committee	Yes
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Chinese University of Hong Kong
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Chinese University of Hong Kong
Verification Date	March 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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