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The Effect of Strawberries in a Cholesterol-Lowering Dietary Portfolio

Primary Purpose

Hyperlipidemia, Cardiovascular Diseases, Hypercholesterolemia

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
strawberry dietary intervention
Sponsored by
University of Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring Strawberry, Almond, Soy protein, viscous dietary fibre, plant sterols, portfolio diet, blood lipids, compliance, blood pressure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre

Outcomes

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

Full Information

First Posted
June 26, 2006
Last Updated
May 7, 2007
Sponsor
University of Toronto
Collaborators
California Strawberry Commission, Almond Board of California, Unilever R&D, Natural Sciences and Engineering Research Council, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00345722
Brief Title
The Effect of Strawberries in a Cholesterol-Lowering Dietary Portfolio
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Toronto
Collaborators
California Strawberry Commission, Almond Board of California, Unilever R&D, Natural Sciences and Engineering Research Council, Canada

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Cardiovascular Diseases, Hypercholesterolemia
Keywords
Strawberry, Almond, Soy protein, viscous dietary fibre, plant sterols, portfolio diet, blood lipids, compliance, blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
strawberry dietary intervention
Primary Outcome Measure Information:
Title
Total cholesterol measured at weeks 0, 2, and 4 of each phase
Title
LDL cholesterol measured at weeks 0, 2, and 4 of each phase
Title
C-reactive protein measured at weeks 0, 2 and 4 of each phase
Title
Blood pressure measured at weeks 0, 2 and 4 of each phase
Secondary Outcome Measure Information:
Title
Apolipoprotein A1 and B measured at weeks 0, 2, and 4 of each phase
Title
Lp(a) measured at weeks 0, 2, and 4 of each phase
Title
Oxidative stress measured at weeks 0, 2, and 4 of each phase
Title
Strawberry intake measured at weeks 0, 2, and 4 of each phase
Title
Compliance to portfolio diet components measured at weeks 0, 2 and 4 of each phase
Title
24 hour urinary potassium measured at weeks 0 and 4 of each phase
Title
24 hour urinary calcium measured at weeks 0 and 4 of each phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David JA Jenkins, MD PhD DSc
Organizational Affiliation
Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, 150 College St. Rm 340, Toronto, ON M5S 3E2, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada

12. IPD Sharing Statement

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The Effect of Strawberries in a Cholesterol-Lowering Dietary Portfolio

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