title: Safety aspects and cholesterol-lowering efficacy of low fat dairy products containing plant sterols.
abstract: OBJECTIVE
  The aim of this study was to investigate whether a plant sterol mixture would reduce serum cholesterol when added to low fat dairy products in subjects with hypercholesterolaemia, and to examine the effects of the mixture on the serum plant sterol and fat-soluble vitamin levels.
  
  
  METHODS
  A parallel, double-blind study.
  
  
  METHODS
  The study was performed in three different locations in Finland.
  
  
  METHODS
  In total, 164 mildly or moderately hypercholesterolaemic subjects participated in the study.
  
  
  METHODS
  The subjects were randomly divided into two groups: a plant sterol group and a control group. The subjects consumed the products for 6 weeks after a 3-week run-in period. The targeted plant sterol intake was 2 g/day in the sterol group.
  
  
  RESULTS
  During the treatment period, there was a 6.5% reduction in serum total cholesterol in the sterol group while no change was observed in the control group (P<0.0005). Serum low-density lipoprotein (LDL) cholesterol was reduced by 10.4% in the sterol group and by 0.6% in the control group (P<0.00005). There was no change during the trial in serum high-density lipoprotein (HDL) cholesterol or triacylglycerol concentrations. The HDL/LDL cholesterol ratio increased by 16.1% in the sterol group and by 4.3% in the control group (P=0.0001). Serum plant sterol levels increased significantly (P=0.0001) in the sterol group. None of the fat-soluble vitamin levels decreased significantly when changes in serum total cholesterol were taken into account. The hypocholesterolaemic effect of sterol administration was not influenced by apolipoprotein E phenotype.
  
  
  CONCLUSIONS
  Yoghurt, low-fat hard cheese and low-fat fresh cheese enriched with a plant sterol mixture reduced serum cholesterol in hypercholesterolaemic subjects and no adverse effects were noted in the dietary control of hypercholesterolaemia.
authors.affiliation: Foundation for Nutrition Research, Helsinki, Finland. riitta.korpela@valio.fi
authors.forename: R
authors.initials: R
authors.lastname: Korpela
authors.forename: J
authors.initials: J
authors.lastname: Tuomilehto
authors.forename: P
authors.initials: P
authors.lastname: Högström
authors.forename: L
authors.initials: L
authors.lastname: Seppo
authors.forename: V
authors.initials: V
authors.lastname: Piironen
authors.forename: P
authors.initials: P
authors.lastname: Salo-Väänänen
authors.forename: J
authors.initials: J
authors.lastname: Toivo
authors.forename: C
authors.initials: C
authors.lastname: Lamberg-Allardt
authors.forename: M
authors.initials: M
authors.lastname: Kärkkäinen
authors.forename: T
authors.initials: T
authors.lastname: Outila
authors.forename: J
authors.initials: J
authors.lastname: Sundvall
authors.forename: S
authors.initials: S
authors.lastname: Vilkkilä
authors.forename: M J
authors.initials: MJ
authors.lastname: Tikkanen
mesh_terms: D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D001057:Apolipoproteins E / Q000235:genetics; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003611:Dairy Products / Q000032:analysis; D004311:Double-Blind Method; D005260:Female; D005527:Food, Fortified; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000178:diet therapy*; D050356:Lipid Metabolism / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D010641:Phenotype; D010840:Phytosterols / Q000009:adverse effects / Q000627:therapeutic use*; D012449:Safety; D014280:Triglycerides / Q000097:blood; D014801:Vitamin A / Q000097:blood; D014807:Vitamin D / Q000097:blood; D014812:Vitamin K / Q000097:blood; D014815:Vitamins / Q000097:blood*
chemical_list: D000924:Anticholesteremic Agents; D001057:Apolipoproteins E; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D010840:Phytosterols; D014280:Triglycerides; D014815:Vitamins; D014801:Vitamin A; D014812:Vitamin K; D014807:Vitamin D; D002784:Cholesterol