The Effect of Strawberries in a Cholesterol-Lowering Dietary Portfolio

NCT00345722 | Completed Phase 2

• 2 other identifiers: REB 03-043CHC-CT#100934
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemia; Cardiovascular Diseases; Hypercholesterolemia

Keywords

Strawberry; Almond; Soy protein; viscous dietary fibre; plant sterols; portfolio diet; blood lipids; compliance; blood pressure

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• 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

Interventions

strawberry dietary intervention PROCEDURE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• California Strawberry Commission: collaborator
• Almond Board of California: collaborator
• Unilever R&D: collaborator
• Natural Sciences and Engineering Research Council, Canada: collaborator

Study Sites (1)

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

Toronto, Ontario, M5C 2T2, Canada

Location

MeSH Terms

Conditions

Hyperlipidemias; Cardiovascular Diseases; Hypercholesterolemia; Patient Compliance

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 26, 2006
• First Posted: June 28, 2006
• Study Start: June 1, 2006
• Study Completion: February 1, 2007
• Last Updated: May 8, 2007

Record last verified: 2007-05

Locations

CA (1)