title: Phytosterol capsules and serum cholesterol in hypercholesterolemia: a randomized controlled trial.
abstract: OBJECTIVE
  Phytosterols are recommended in combination with diet therapy to reduce elevated LDL-cholesterol level. Meta-analyses indicate a 10% reduction in LDL-cholesterol from intake of approximately 2 g phytosterols/d incorporated into fat-based foods. However, the cholesterol lowering effect from capsules containing phytosterols is less documented. The pre-specified primary endpoint of the present study was to investigate the effect of capsules with phytosterols on circulating LDL-cholesterol in patients with mild to moderate hypercholesterolemia.
  
  
  METHODS
  In a double-blinded, randomized, placebo-controlled crossover study, 41 men and women were randomized into two four-weeks intervention periods with softgel capsules containing either phytosterols (2.0 g/d) or sunflower oil. There was a three-weeks washout period between the intervention periods.
  
  
  RESULTS
  No significant difference in total- or LDL-cholesterol between the phytosterol and the placebo period were observed after four weeks intervention (0.0 mmol/L (95%CI: -0.3 to 0.2), P = 0.74 and -0.1 mmol/L (95%CI: -0.3 to 0.1), P = 0.32, respectively).
  
  
  CONCLUSIONS
  Daily intake of capsules containing 2 g phytosterols did not reduce total- or LDL-cholesterol significantly in a highly relevant target group for the use of phytosterol products. The present results may emphasize the importance of choosing a suitable dosage-delivery system in order to achieve optimal cholesterol lowering effect. The study was registered at www.clinicaltrials.gov, IDno:NCT00485095.
authors.affiliation: Faculty of Health, Nutrition and Management, Akershus University College, P.O. Box 423, 2001 Lillestrøm, Norway.
authors.forename: Inger
authors.initials: I
authors.lastname: Ottestad
authors.forename: Leiv
authors.initials: L
authors.lastname: Ose
authors.forename: Marianne H
authors.initials: MH
authors.lastname: Wennersberg
authors.forename: Linda
authors.initials: L
authors.lastname: Granlund
authors.forename: Bente
authors.initials: B
authors.lastname: Kirkhus
authors.forename: Kjetil
authors.initials: K
authors.lastname: Retterstøl
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000924:Anticholesteremic Agents / Q000008:administration & dosage* / Q000737:chemistry; D015415:Biomarkers / Q000097:blood; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D008078:Cholesterol, LDL / Q000097:blood*; D018592:Cross-Over Studies; D019587:Dietary Supplements; D004311:Double-Blind Method; D015536:Down-Regulation; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009664:Norway; D010840:Phytosterols / Q000008:administration & dosage* / Q000737:chemistry; D010938:Plant Oils / Q000737:chemistry; D012720:Severity of Illness Index; D000074242:Sunflower Oil; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D015415:Biomarkers; D002214:Capsules; D008078:Cholesterol, LDL; D010840:Phytosterols; D010938:Plant Oils; D000074242:Sunflower Oil