The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy

This study has been completed.
Sponsor:
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00877825
First received: April 3, 2009
Last updated: April 7, 2009
Last verified: April 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy

Resource links provided by NLM:


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
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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 by University of Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00877825     History of Changes
Other Study ID Numbers: REB235U
Study First Received: April 3, 2009
Last Updated: April 7, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
Diet Therapy

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 20, 2014