Overview

This trial is active, not recruiting.

Conditions hyperlipidemia, cardiovascular diseases, hypercholesterolemia
Treatment dietary portfolio of cholesterol-lowering foods
Phase phase 2
Sponsor University of Toronto
Collaborator Canada Research Chairs Endowment of the Federal Government of Canada
Start date January 2004
End date April 2010
Trial size 66 participants
Trial identifier NCT00438893, HC-CT#100934, REB 03-043

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 single food components from the dietary portfolio on cholesterol reduction and other cardiovascular risk factors.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Dietary advice to consume a dietary portfolio of cholesterol-lowering foods
dietary portfolio of cholesterol-lowering foods
A plant based dietary portfolio providing plant sterols (1.0g/1000 kcal), soy protein (22.5g/1000 kcal, viscous fibers 10 g/1000 kcal and almonds 22.5g/1000 kcal)

Primary Outcomes

Measure
Total cholesterol
time frame: At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years
LDL cholesterol
time frame: At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years
C-reactive protein
time frame: At weeks 0, 12, 24, 34, 52; then every 6 months to a total of 5 years
Blood pressure
time frame: At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years

Secondary Outcomes

Measure
Body Weight
time frame: At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years
Apolipoprotein A1 and B
time frame: At weeks 0, 2,4, 8,12, 18, 24, 34, 44, 52; then every 2 months to a total of 5 years
Lp(a)
time frame: At weeks 0, 24, 52; then every 6 months to a total of 5 years
Routine Biochemistry and hematology measurements
time frame: At week 0, 12, 24 and every 6 months to 5 years
Compliance to dietary portfolio components
time frame: At years, 1, 2, 3, 4 and 5
24 hour urinary markers and electrolytes (optional)
time frame: At week 0 and end of years 1, 2, 3, 4 and 5
Oxidative stress markers
time frame: week 0 and every 6 months to 5 years

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

Official title The Long-Term Effect of Viscous Fibers, Soy Protein, and Plant Sterol Foods in Combination on Serum Cholesterol and Other Risk Factors for Cardiovascular Disease
Principal investigator David JA Jenkins, MD, PhD, DSc
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 extent as first generation statins (cholesterol-lowering drugs). However, the long-term effectiveness of the dietary portfolio is not known. Furthermore, it is not known to what extent each of the food components contribute to the cholesterol reductions observed. We wish to therefore evaluate the long term effects of the dietary portfolio as well as the effects of removing single food components from the dietary portfolio on cholesterol reduction and other cardiovascular risk factors. We believe the removal of single food components will result in a reduction of the cholesterol-lowering effect to a similar extent as predicted with the cholesterol reductions observed when the food component is consumed alone. Method: 66 subjects will be recruited for a 6-month to 5 year long-term dietary portfolio study with the option for continuation (re-consenting) at the end of 6, 12 or 24 months. The active dietary components consist of viscous fibers (including oat bran), soy products (including soy milk), almonds and plant sterols (sterol-enriched margarine). Lipids, blood pressure, body weight, and routine biochemical and hematology analyses will be performed over the 5 year period, with lipids and blood pressure measured at 2 monthly intervals. 40-50 subjects on the long term dietary portfolio study, all of whom will have been on the diet for at least 1 year, will be asked to remove a specific food component from their regular dietary portfolio for a 10 week period. After the 10 week period, subjects will be asked return to the normal dietary portfolio with all food components consumed and continue on the long-term dietary portfolio. Bloods will be taken at weeks 0, 6 and 10 of the food component removal period; and at 2-monthly intervals for 20 weeks prior to and after the 10 week period while on the long-term dietary portfolio with all food components.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by University of Toronto.