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The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy

Sponsor
University of Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT00877825
Collaborator
(none)

Study Details

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
  • Procedure: dairy food control diet and high- and low- isoflavone soyfood diets
 Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy
Actual Study Completion Date :
Apr 1, 2000

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Toronto

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00877825
    Other Study ID Numbers:
    • REB235U
    First Posted:
    Apr 8, 2009
    Last Update Posted:
    Apr 8, 2009
    Last Verified:
    Apr 1, 2009
    Keywords provided by , ,
    Diet Therapy
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Hyperlipidemias

    Study Results

    No Results Posted as of Apr 8, 2009