Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 5, 2009
March 5, 2009
October 2007
April 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effects of Soy Protein and Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors
The Effects of Soy Protein and/or Isoflavones on Glycemic Control, Insulin Sensitivity and Cardiovascular Risk Factors-a Six Months RCT Among Postmenopausal Women

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.

Not Provided
Interventional
Not Provided
Not Provided
  • Diabetes
  • Cardiovascular Risk
  • Dietary Supplement: soy protein
  • Dietary Supplement: isoflavones
  • Dietary Supplement: milk protein
  • 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
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.
 
Completed
Not Provided
Not Provided
April 2008   (final data collection date for primary outcome measure)

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.
Female
46 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00856882
CUHK4450/06M
Yes
Not Provided
Chinese University of Hong Kong
Not Provided
Not Provided
Chinese University of Hong Kong
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP