The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy

University of Toronto

Status and phase: Completed; Phase 2

Conditions: Hyperlipidemia; Cardiovascular Diseases

Treatments: Procedure: dairy food control diet and high- and low- isoflavone soyfood diets

Study type: Interventional

Funder types: Other

Identifiers

NCT00877825

REB235U

Details and patient eligibility

About

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.

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind