The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy

This study has been completed.

First Received: April 3, 2009 Last Updated: April 7, 2009 History of Changes

Sponsored by:	University of Toronto
Information provided by:	University of Toronto
ClinicalTrials.gov Identifier:	NCT00877825

Purpose

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.

Condition	Intervention	Phase
Hyperlipidemia Cardiovascular Diseases	Procedure: dairy food control diet and high- and low- isoflavone soyfood diets	Phase II

MedlinePlus related topics: Diets

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Crossover Assignment
Official Title:	The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy

Further study details as provided by University of Toronto:

Study Completion Date:

April 2000

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877825

Sponsors and Collaborators

University of Toronto

Investigators

Principal Investigator:

David JA Jenkins, MD, PhD, DSc

University of Toronto and St. Michael's Hospital

More Information

No publications provided

Study ID Numbers:	REB235U
Study First Received:	April 3, 2009
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00877825 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Toronto:

Diet Therapy

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Metabolic Diseases
Hyperlipidemias
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009