The Effect of Strawberries in a Cholesterol-Lowering Dietary Portfolio

May 7, 2007 updated by: University of Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5C 2T2
        • Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

Almond Board of California
Unilever R&D
Natural Sciences and Engineering Research Council, Canada
California Strawberry Commission

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

June 26, 2006

First Submitted That Met QC Criteria

June 26, 2006

First Posted (Estimate)

June 28, 2006

Study Record Updates

Last Update Posted (Estimate)

May 8, 2007

Last Update Submitted That Met QC Criteria

May 7, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB 03-043C
  • HC-CT#100934

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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