NCT00877825

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

April 1, 2000

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
Last Updated

April 8, 2009

Status Verified

April 1, 2009

First QC Date

April 3, 2009

Last Update Submit

April 7, 2009

Conditions

HyperlipidemiaCardiovascular Diseases

Keywords

Diet Therapy

Interventions

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

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and post-menopausal women
  • LDL-C \> 4.1mmol/L at recruitment
  • living within a 40 km radius of St. Michael's Hospital

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 22301925DERIVED

MeSH Terms

Conditions

HyperlipidemiasCardiovascular Diseases

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • David JA Jenkins, MD, PhD, DSc

    University of Toronto and St. Michael's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 8, 2009

Study Completion

April 1, 2000

Last Updated

April 8, 2009

Record last verified: 2009-04