Status:
COMPLETED
Effect of Plant Stanol Ester-Containing Spread on Estimated Cardiovascular Risk in Comparison to Mediterranean Diet
Lead Sponsor:
Hellenic Atherosclerosis Society
Collaborating Sponsors:
Minerva SA
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
45-80 years
Phase:
PHASE4
Brief Summary
Since it is very difficult to have the real thing (Mediterranean diet) we need to find an alternative to reduce cardiovascular disease (CVD) risk in subjects with moderate hypercholesterolaemia (a maj...
Detailed Description
Design: Randomised, double blind, placebo controlled study Number of participants: 150 (3 groups with 50 subjects each). Intervention: One group will be assigned to stanol ester spread (2 g/day) based...
Eligibility Criteria
Inclusion
- Male and female subjects over 45 years of age with mild hypercholesterolaemia (TC levels: 200 mg/dl - 230 mg/dl)
Exclusion
- Subjects with
- Established CVD (coronary heart disease, peripheral arterial disease, aortic aneurysm, or symptomatic carotid artery disease) or T2DM
- Chronic diseases (including liver diseases)
- Pregnancy
- Malignancies
- Unwillingness to participate
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00793364
Start Date
November 1 2008
End Date
April 1 2009
Last Update
May 28 2009
Active Locations (1)
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1
Aristotelian University, Hippocration Hospital
Thessaloniki, Greece, 55132