The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy

April 7, 2009 updated by: University of Toronto
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (ACTUAL)

April 1, 2000

Study Registration Dates

First Submitted

April 3, 2009

First Submitted That Met QC Criteria

April 7, 2009

First Posted (ESTIMATE)

April 8, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 8, 2009

Last Update Submitted That Met QC Criteria

April 7, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB235U

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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