Status:
COMPLETED
The Effect of Strawberries in a Cholesterol-Lowering Dietary Portfolio
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
California Strawberry Commission
Almond Board of California
Conditions:
Hyperlipidemia
Cardiovascular Diseases
Eligibility:
All Genders
21+ years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00345722
Start Date
June 1 2006
End Date
February 1 2007
Last Update
May 8 2007
Active Locations (1)
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1
Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Hospital Health Centre
Toronto, Ontario, Canada, M5C 2T2