The Effect of Strawberries in a Cholesterol-Lowering Dietary Portfolio
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.
Procedure: strawberry dietary intervention
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Total cholesterol measured at weeks 0, 2, and 4 of each phase
- LDL cholesterol measured at weeks 0, 2, and 4 of each phase
- C-reactive protein measured at weeks 0, 2 and 4 of each phase
- Blood pressure measured at weeks 0, 2 and 4 of each phase
- Apolipoprotein A1 and B measured at weeks 0, 2, and 4 of each phase
- Lp(a) measured at weeks 0, 2, and 4 of each phase
- Oxidative stress measured at weeks 0, 2, and 4 of each phase
- Strawberry intake measured at weeks 0, 2, and 4 of each phase
- Compliance to portfolio diet components measured at weeks 0, 2 and 4 of each phase
- 24 hour urinary potassium measured at weeks 0 and 4 of each phase
- 24 hour urinary calcium measured at weeks 0 and 4 of each phase
|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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345722
|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|