The Effect of Strawberries in a Cholesterol-Lowering Dietary Portfolio

This study has been completed.
Sponsor:
Collaborators:
California Strawberry Commission
Almond Board of California
Unilever R&D
Natural Sciences and Engineering Research Council, Canada
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00345722
First received: June 26, 2006
Last updated: May 7, 2007
Last verified: May 2007
  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
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

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00345722     History of Changes
Other Study ID Numbers: REB 03-043C, HC-CT#100934
Study First Received: June 26, 2006
Last Updated: May 7, 2007
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

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
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 21, 2014