The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy

NCT ID: NCT00877825

Last Updated: 2009-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Completion Date

2000-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperlipidemia Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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dairy food control diet and high- and low- isoflavone soyfood diets

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Toronto

OTHER

Sponsor Role lead

Principal Investigators

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David JA Jenkins, MD, PhD, DSc

Role: PRINCIPAL_INVESTIGATOR

University of Toronto and St. Michael's Hospital

References

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Wong JM, Kendall CW, Marchie A, Liu Z, Vidgen E, Holmes C, Jackson CJ, Josse RG, Pencharz PB, Rao AV, Vuksan V, Singer W, Jenkins DJ. Equol status and blood lipid profile in hyperlipidemia after consumption of diets containing soy foods. Am J Clin Nutr. 2012 Mar;95(3):564-71. doi: 10.3945/ajcn.111.017418. Epub 2012 Feb 1.

Reference Type DERIVED
PMID: 22301925 (View on PubMed)

Other Identifiers

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REB235U

Identifier Type: -

Identifier Source: org_study_id

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