The Effect of Strawberries in a Cholesterol-Lowering Dietary Portfolio

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345722
• Other study ID #: REB 03-043C
• Secondary ID: HC-CT#100934
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2006
• Last updated: May 7, 2007
• Start date: June 2006
• Est. completion date: February 2007

Study information

• Verified date: May 2007
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypercholesterolemia
• Hyperlipidemia
• Hyperlipidemias

Intervention

Procedure:
• strawberry dietary intervention

Locations

Country	Name	City	State
Canada	Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre	Toronto	Ontario

Sponsors (5)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cholesterol measured at weeks 0, 2, and 4 of each phase
Primary	LDL cholesterol measured at weeks 0, 2, and 4 of each phase
Primary	C-reactive protein measured at weeks 0, 2 and 4 of each phase
Primary	Blood pressure measured at weeks 0, 2 and 4 of each phase
Secondary	Apolipoprotein A1 and B measured at weeks 0, 2, and 4 of each phase
Secondary	Lp(a) measured at weeks 0, 2, and 4 of each phase
Secondary	Oxidative stress measured at weeks 0, 2, and 4 of each phase
Secondary	Strawberry intake measured at weeks 0, 2, and 4 of each phase
Secondary	Compliance to portfolio diet components measured at weeks 0, 2 and 4 of each phase
Secondary	24 hour urinary potassium measured at weeks 0 and 4 of each phase
Secondary	24 hour urinary calcium measured at weeks 0 and 4 of each phase