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Sponsors and Collaborators: |
University of Toronto California Strawberry Commission Almond Board of California Unilever Canada Natural Sciences and Engineering Research Council, Canada |
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Information provided by: | University of Toronto |
ClinicalTrials.gov Identifier: | NCT00345722 |
The purpose of this study is to determine whether addition of strawberries to a dietary portfolio of cholesterol-lowering foods will improve compliance and so increase the effectiveness of the dietary portfolio in lowering cholesterol and improving cardiovascular risk factors.
Condition | Intervention | Phase |
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Hyperlipidemia Cardiovascular Diseases Hypercholesterolemia |
Procedure: strawberry dietary intervention |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | June 2006 |
Study Completion Date: | February 2007 |
We have shown in 1-month metabolic studies that the dietary portfolio can lower cholesterol to the same extent as first generation statins (cholesterol-lowering drugs). In the on-going long-term 'real world' study using this dietary portfolio, only one-third of participants were able to achieve similar cholesterol reductions at the end of 1 year. Varying compliance has been identified as the main issue why the other two-thirds could not achieve a similar level of reduction. We believe the addition of strawberries to this diet, by virtue of their beneficial components (fibre and antioxidants)and by replacement of less desirable foods (fatty deserts), may further improve the CHD risk profile of a very effective cholesterol reduction strategy.
Method:
454 g of strawberries per 2000 kcal per day will be provided for a one-month period to approximately 40-50 subjects on a long-term dietary portfolio study, all of whom have been on the diet for at least 6 months to 1 year. The active dietary components consist of viscous vibers (including oat bran), soy products (including soy milk), almonds and plant sterols (sterol enriched margarine). Strawberry recipes will be used to enhance compliance of these components. Subjects will undergo the study in a randomized crossover design where the control will be the dietary portfolio with additional 65 g oatbran bread (without psyllium) replacing the strawberries.
Bloods will be taken at weeks 0, 2 and 4 of each treatment period; and at one month prior to and after the 8-week study while on the long-term dietary portfolio.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
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, 150 College St. Rm 340, Toronto, ON M5S 3E2, Canada |
Study ID Numbers: | REB 03-043C, HC-CT#100934 |
Study First Received: | June 26, 2006 |
Last Updated: | May 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00345722 |
Health Authority: | Canada: Ethics Review Committee; Canada: Health Canada |
Strawberry Almond Soy protein viscous dietary fibre plant sterols |
portfolio diet blood lipids compliance blood pressure |
Metabolic Diseases Hyperlipidemias Metabolic disorder |
Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Cardiovascular Diseases |