Effects of a Long Term Dietary Portfolio and of Sequential Removal of Food Components From the Diet
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|ClinicalTrials.gov Identifier: NCT00438893|
Recruitment Status : Unknown
Verified July 2013 by David Jenkins, University of Toronto.
Recruitment status was: Active, not recruiting
First Posted : February 22, 2007
Last Update Posted : July 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hyperlipidemia Cardiovascular Diseases Hypercholesterolemia||Dietary Supplement: Dietary portfolio of cholesterol-lowering foods||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||April 2010|
A portfolio of cholesterol-lowering foods
Dietary advice to consume a dietary portfolio of cholesterol-lowering foods
Dietary Supplement: 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)
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438893
|Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre|
|Toronto, Ontario, Canada, M5C 2T2|
|Principal Investigator:||David JA Jenkins, MD, PhD, DSc||Department of Nutritional Sciences, Faculty of Medicine, University of Toronto|