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The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy

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ClinicalTrials.gov Identifier: NCT00877825
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : April 8, 2009
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Cardiovascular Diseases Procedure: dairy food control diet and high- and low- isoflavone soyfood diets Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy
Study Completion Date : April 2000
Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877825

Sponsors and Collaborators
University of Toronto
Principal Investigator: David JA Jenkins, MD, PhD, DSc University of Toronto and St. Michael's Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00877825     History of Changes
Other Study ID Numbers: REB235U
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: April 8, 2009
Last Verified: April 2009

Keywords provided by University of Toronto:
Diet Therapy

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