European Journal of Nutrition

, Volume 42, Issue 2, pp 111–117

A phytosterol-enriched spread improves the lipid profile of subjects with type 2 diabetes mellitus

A randomized controlled trial under free-living conditions
  • Yu-Mi Lee
  • Burkhard Haastert
  • Werner Scherbaum
  • Hans Hauner
ORIGINAL CONTRIBUTION

DOI: 10.1007/s00394-003-0401-y

Cite this article as:
Lee, YM., Haastert, B., Scherbaum, W. et al. Eur J Nutr (2003) 42: 111. doi:10.1007/s00394-003-0401-y

Summary.

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. Aim of the study: Investigation of the effect of a phytosterol-enriched spread in subjects with type 2 diabetes mellitus on serum lipids, HbA1c, 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 × 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 HbA1c 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.

Key words type 2 diabetes mellitus – phytosterol – LDL cholesterol – hypercholesterolemia – phytosterol-enriched spread

Copyright information

© Steinkopff Verlag 2003

Authors and Affiliations

  • Yu-Mi Lee
    • 1
  • Burkhard Haastert
    • 2
  • Werner Scherbaum
    • 1
  • Hans Hauner
    • 1
  1. 1.Klinische Abteilung, Deutsches Diabetes-Forschungsinstitut, an der Heinrich-Heine-Universität Düsseldorf, Auf'm Hennekamp 65, 40225 Düsseldorf, Germany. hauner@ddfi.uni-duesseldorf.deDE
  2. 2.Abteilung Biometrie und Klinische Epidemiologie, an der Heinrich-Heine-Universität Düsseldorf, Düsseldorf, GermanyDE