Hypercholesterolemia Clinical Trial
Official title:
Effects of Long-term Daily Consumption of Plant Sterol or Stanol Esters in Statin-treated Patients
BACKGROUND Plant sterols and stanols are compounds that are structurally related to
cholesterol, which decrease intestinal cholesterol absorption and consequently serum LDL
cholesterol concentrations by 10-14%. Nowadays plant sterols and stanols are widely available
incorporated in food products like margarines and yogurts and are presented as functional
foods.
Whether the cholesterol lowering effects of plant sterols and stanols also favorably affect
endothelial function in humans is currently unknown. Apart from their cholesterol lowering
effects, plant sterols and stanols might have other effects like effects on red blood cell
properties, cognitive performance and antioxidant status. Especially to evaluate effects on
this type of parameters long-term daily consumption of plant sterols and stanols is
necessary. These questions will be answered in statin treated patients since functional foods
enriched with plant sterol and stanol esters have been recommended for statin-users as an
"add on" therapy. This may ultimately lead to a lower dose of statins or an increased number
of patients that reach the target for LDL-cholesterol reduction.
AIM The major objective of the present proposal is to examine the effects of a long-term
consumption of plant sterols and stanols on the endothelial function of the vessel wall in
statin-treated patients.
STUDY DESIGN Subjects: The subjects will be recruited among men and women in Maastricht and
surroundings, aged between 18 and 70 years. Participation will be on voluntary basis. People
who are willing to participate will be invited for two screening visits.
Experimental design: The present study is a double-blind, randomized parallel intervention
trial with 60 statin-treated subjects, in which the metabolic effects of a long term (90
weeks) consumption of plant sterols and stanols (2.5 g/day) will be studied. After a run-in
period of 5 weeks the subjects will be randomly divided into three groups of 20 subjects
each. One group will continue with the control margarine without added plant sterols and
stanols, one group will use a plant sterol margarine and the last group will use a plant
stanol margarine for 85 weeks. The major endpoint will be endothelial function of the vessel
wall, and in addition various parameters related to lipids and lipoprotein metabolism,
erythrocyte characteristics and cognitive performance will be measured.
Risk for subjects The margarines containing the plant sterols and stanols are safe and
palatable. Venipunctures and other (non-invasive) measurements are carried out by skilled
persons and not of any risk. A subject will spend approximately 1 hour a month in
participating in the studies.
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