Back to resultsThe Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy
Primary Purpose
Hyperlipidemia, Cardiovascular Diseases
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
dairy food control diet and high- and low- isoflavone soyfood diets
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemia focused on measuring Diet Therapy
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00877825
Brief Title
The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy
Official Title
The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
April 2000 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Toronto
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Cardiovascular Diseases
Keywords
Diet Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
dairy food control diet and high- and low- isoflavone soyfood diets
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David JA Jenkins, MD, PhD, DSc
Organizational Affiliation
University of Toronto and St. Michael's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22301925
Citation
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.
Results Reference
derived
Learn more about this trial
The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy
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