Hypercholesterolemia Clinical Trial
Official title:
The Effect of Three Different Stanol Ester Doses in Margarines on Cholesterol Absorption Efficiency
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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