Status:
COMPLETED
Effects of a Long Term Dietary Portfolio and of Sequential Removal of Food Components From the Diet
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
Canada Research Chairs Endowment of the Federal Government of Canada
Natural Sciences and Engineering Research Council, Canada
Conditions:
Hyperlipidemia
Cardiovascular Diseases
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the long term effectiveness of the dietary portfolio, consisting of viscous fibers, soy products, nuts and plant sterols, as well as the effects of removing si...
Detailed Description
We have shown in 1-month metabolic studies that a dietary portfolio, consisting of soy products, viscous fibers, almonds and plant sterols in the form of margarine, can lower cholesterol to the same e...
Eligibility Criteria
Inclusion
- Healthy adult men and postmenopausal women currently enrolled in the long-term portfolio study
- Body mass index \<32 kg/m2
- Constant body weight over last 6 months preceding the onset of the study
- Fasting LDL-cholesterol concentration \>4.1 mmol/L at diagnosis
Exclusion
- women of child-bearing potential
- major cardiovascular event (stroke or myocardial infarction)
- positive molecular diagnosis of familial hypercholesterolemia
- secondary causes of hypercholesterolemia (hypothyroidism, unless treated \& on a stable dose of L-thyroxine, renal or liver disease)
- use of cholesterol-lowering medications
- serum triglycerides \>4.5 mmol/L
- blood pressure \> 145/90 mmHg
- diabetes and/or major disorders such as liver disease, renal failure or cancer
- major surgery \<6 months prior to randomization
- alcohol consumption \>2 drinks per day
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00438893
Start Date
September 1 2003
End Date
May 1 2009
Last Update
October 15 2018
Active Locations (1)
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1
Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre
Toronto, Ontario, Canada, M5C 2T2