title: Safety of long-term consumption of plant sterol esters-enriched spread.
abstract: OBJECTIVE
  To evaluate both efficacy and safety in humans of long-term consumption of spreads containing plant sterol esters.
  
  
  METHODS
  Randomized double-blind placebo-controlled parallel trial.
  
  
  METHODS
  : Hundred and eighty-five healthy volunteers (35-64 y).
  
  
  METHODS
  Volunteers daily consumed 20 g spread enriched with 1.6 g plant sterols as fatty acid esters or a control spread for 1 y. They continued their habitual diet and lifestyle. Outcome measures included efficacy markers such as total and LDL-cholesterol, a large range of safety parameters, and reporting of adverse events.
  
  
  RESULTS
  Consumption of the plant sterol ester-enriched spread consistently lowered total and LDL cholesterol during the 1 y period on average by 4 and 6%, respectively (0.01 < P < 0.05). Plant sterols intake did on average not result in a lower carotenoid concentration (when expressed per LDL-cholesterol) after 52 weeks (P>0.05). However, carotenoid concentrations changed over time. Plant sterols intake reduced lipid adjusted alpha- and beta-carotene-concentrations by only 15-25% after 1 y, relative to control. Lipid-adjusted fat-soluble vitamin concentrations remained unchanged. Plant sterol concentrations in serum were increased from 2.76 to 5.31 ( micro mol/mmol total cholesterol) for campesterol (P<0.0001) and from 1.86 to 2.47 ( micro mol/mmol total cholesterol) for beta-sitosterol (P<0.0001). The increase in total plant sterol concentration in red blood cells (5.29-9.62 micro g/g) did not affect red blood cell deformability. Hormone levels in males (free and total testosterone) and females (luteinizing hormone, follicle stimulating hormone, beta-estradiol and progesterone) as well as all clinical chemical and hematological parameters measured were unaffected. Adverse events reported were not different between subjects consuming control spread and subjects consuming plant sterol esters-enriched spread.
  
  
  CONCLUSIONS
  Consumption of a plant sterol esters-enriched spread is an effective way to consistently lower blood cholesterol concentrations and is safe to use over a long period of time.
authors.affiliation: TNO Nutrition and Food Research, Department of Nutritional Physiology, Zeist, The Netherlands. hendriks@voeding.tno.nl
authors.forename: H F J
authors.initials: HF
authors.lastname: Hendriks
authors.forename: E J
authors.initials: EJ
authors.lastname: Brink
authors.forename: G W
authors.initials: GW
authors.lastname: Meijer
authors.forename: H M G
authors.initials: HM
authors.lastname: Princen
authors.forename: F Y
authors.initials: FY
authors.lastname: Ntanios
mesh_terms: D000328:Adult; D002338:Carotenoids / Q000097:blood; D002784:Cholesterol / Q000031:analogs & derivatives* / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004032:Diet; D004041:Dietary Fats / Q000008:administration & dosage; D004311:Double-Blind Method; D004952:Esters / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008383:Margarine; D008875:Middle Aged; D010840:Phytosterols / Q000008:administration & dosage* / Q000009:adverse effects; D010919:Placebos; D012855:Sitosterols / Q000097:blood; D019207:beta Carotene / Q000097:blood
chemical_list: D008078:Cholesterol, LDL; D004041:Dietary Fats; D004952:Esters; D010840:Phytosterols; D010919:Placebos; D012855:Sitosterols; D019207:beta Carotene; D002338:Carotenoids; C021273:campesterol; C025473:gamma-sitosterol; D008383:Margarine; D002784:Cholesterol