A Phase 4 interventional study of plant stanol consumption in Hypercholesterolemia, sponsored by Oy Foodfiles Ltd. Completed at 1 site in Finland. Open to participants aged 25 Years to 68 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-07-06.
Sponsored by Oy Foodfiles Ltd · Phase 4, Interventional, and Treatment
This study aims to measure the effect of three different doses of plant stanols in margarine on the cholesterol absorption efficiency in subjects with mildly to moderately increased serum LDL cholesterol concentrations
Serum cholesterol lowering effect of plant sterols is well established and it is also known that plant stanols inhibit the absorption of cholesterol. However, there is lack of dose-response studies directly measuring the cholesterol absorption efficiency during prolonged consumption of plant stanols. Therefore this study aims to measure the cholesterol absorption efficiency at different plant stanol consumption levels using a stable isotope tracer method.
Subjects will be randomized in their study groups that consume 20 g of margarine with different doses of plants stanols (0.8, 1.6 and 2.0g) based on cholesterol absorption efficiency at screening (high and low absorbers randomised separately). Cholesterol absorption test with cholesterol tracer will be conducted twice: at baseline and after 2-3 weeks margarine consumption period.
Cholesterol absorption efficiency will also be examined by indirect method i.e. by following the concentrations of serum cholesterol precursors and plant sterols in blood. In addition serum total, LDL and HDL cholesterol and triglycerides are followed.
1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.
This study's enrollment of 60 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →This is the only study on the registry with Oy Foodfiles Ltd as lead sponsor.
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Exclusion Criteria:
cholesterol absorption efficiency
changes in blood lipids
This study is completed, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.
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