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

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.

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Key information

Conditions

Diabetes Cardiovascular Risk Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

46 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Soy protein

Dietary Supplement

isoflavones

Dietary Supplement

Milk protein

Dietary Supplement

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2008
First posted: Mar 6, 2009
Registry last updated: Mar 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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