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The Effect of Strawberries in a Cholesterol-Lowering Dietary Portfolio

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345722
First Posted: June 28, 2006
Last Update Posted: May 8, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
California Strawberry Commission
Almond Board of California
Unilever R&D
Natural Sciences and Engineering Research Council, Canada
Information provided by:
University of Toronto
  Purpose
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
Hyperlipidemia Cardiovascular Diseases Hypercholesterolemia Procedure: strawberry dietary intervention Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 50
Study Start Date: June 2006
Study Completion Date: February 2007
Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult men and postmenopausal women currently enrolled in the long-term dietary 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 mmmol/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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00345722


Locations
Canada, Ontario
Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre
Toronto, Ontario, Canada, M5C 2T2
Sponsors and Collaborators
University of Toronto
California Strawberry Commission
Almond Board of California
Unilever R&D
Natural Sciences and Engineering Research Council, Canada
Investigators
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
  More Information

ClinicalTrials.gov Identifier: NCT00345722     History of Changes
Other Study ID Numbers: REB 03-043C
HC-CT#100934
First Submitted: June 26, 2006
First Posted: June 28, 2006
Last Update Posted: May 8, 2007
Last Verified: May 2007

Keywords provided by University of Toronto:
Strawberry
Almond
Soy protein
viscous dietary fibre
plant sterols
portfolio diet
blood lipids
compliance
blood pressure

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypercholesterolemia
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases