title: A phytosterol-enriched spread improves the lipid profile of subjects with type 2 diabetes mellitus--a randomized controlled trial under free-living conditions.
abstract: BACKGROUND
  Phytosterol-enriched margarines are known to significantly lower total and LDL cholesterol, but little is known about the effect of such margarines in subjects with type 2 diabetes.
  
  
  OBJECTIVE
  Investigation of the effect of a phytosterol-enriched spread in subjects with type 2 diabetes mellitus on serum lipids, Hb(A1c), and blood glucose under free-living conditions.
  
  
  METHODS
  Randomized, placebo-controlled, double-blind clinical trial in two parallel groups over 12 weeks; 85 type 2 diabetic patients with serum LDL cholesterol levels >/= 3.60 mmol/l and without hypolipidemic medication were included in the study. Participants consumed 2 x 10 g of spread with or without 8 % phytosterol-esters daily. Fasting blood samples were analyzed at 0, 4, 8, and 12 weeks.
  
  
  RESULTS
  After 4 weeks, total and LDL cholesterol were significantly reduced in the phytosterol group by 5.2 % and 6.8 %, respectively, compared to baseline (p < 0.05). After 8 and 12 weeks, these reductions became smaller and were not significant any more compared to baseline or between the groups, but a repeated measurement analysis demonstrated a significant difference for both variables between the two groups (each p < 0.05). HDL cholesterol was significantly increased in the phytosterol group compared to the placebo group after 8 and 12 weeks, but there was no overall difference in the repeated measurement analysis between the two groups. In the phytosterol group, there was a small reduction in Hb(A1c) compared to the control group which was only significant after 4 weeks.
  
  
  CONCLUSIONS
  This clinical study shows that a phytosterol-enriched spread is effective in lowering total and LDL cholesterol in subjects with type 2 diabetes but also illustrates the difficult maintenance under free-living conditions over time. Although this effect is modest, it may contribute to decreasing the elevated risk of cardiovascular disease in type 2 diabetes.
authors.affiliation: Klinische Abteilung, Deutsches Diabetes-Forschungsinstitut, an der Heinrich-Heine-Universität Düsseldorf, Auf'm Hennekamp 65, 40225 Düsseldorf, Germany.
authors.forename: Yu-Mi
authors.initials: YM
authors.lastname: Lee
authors.forename: Burkhard
authors.initials: B
authors.lastname: Haastert
authors.forename: Werner
authors.initials: W
authors.lastname: Scherbaum
authors.forename: Hans
authors.initials: H
authors.lastname: Hauner
mesh_terms: D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005527:Food, Fortified; D019270:Fructosamine / Q000097:blood; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D008055:Lipids / Q000097:blood*; D008297:Male; D008383:Margarine; D008875:Middle Aged; D010840:Phytosterols / Q000008:administration & dosage* / Q000097:blood; D012111:Residence Characteristics
chemical_list: D001786:Blood Glucose; D019270:Fructosamine; D006442:Glycated Hemoglobin; D008055:Lipids; D008383:Margarine; D010840:Phytosterols