Long Term Effects of Plant Sterol and Stanol Esters
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): stanol ester; sterol ester; No intervention
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): enriched margarine; enriched margarine; placebo margarine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science