The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy

Phase 2

Completed

• Conditions: Hyperlipidemia; Cardiovascular Diseases

• Registration Number: NCT00877825
• Lead Sponsor: University of Toronto

Brief Summary

Isoflavonoids, through their estrogen-like activity, are in part responsible for the cholesterol lowering properties of soy foods. If this is found to be so, then it would be advantageous not only to promote soy consumption, but also to identify and use soy cultivars with high isoflavonoid content in production of soy food products. These foods may have a use in the reduction of serum cholesterol and if they effectively increase the phytoestrogen activity of soy, may have a role in the prevention of other hormone dependent diseases (e.g. osteoporosis, certain cancers) in the same way as natural estrogens.

Detailed Description

Not available

Study Timeline

• Study Completion: 2000-04
• Status Verified: 2009-04
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-07
• Last Update Submitted: 2009-04-07
• Study First Posted: 2009-04-08
• Last Update Posted: 2009-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• men and post-menopausal women
• LDL-C > 4.1mmol/L at recruitment
• living within a 40 km radius of St. Michael's Hospital

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Exclusion Criteria

• lipid lowering medications
• clinical or biochemical evidence of diabetes, renal or hepatic disease
• body mass index (BMI) >38 kg/m2
• antibiotic use within the last three months
• hormone replacement therapy
• smoking or significant alcohol use (>1 drink/d)
• triglyceride level > 4.0mmol/L

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER