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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856882
• Other study ID #: CUHK4450/06M
• Status: Completed
• Phase: N/A
• First received: March 5, 2009
• Last updated: March 5, 2009
• Start date: October 2007

Study information

• Verified date: March 2009
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 46 Years to 70 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Risk
• Diabetes

Intervention

Dietary Supplement:
• soy protein

• isoflavones

• milk protein

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong