title: Safety and tolerability of esterified phytosterols administered in reduced-fat spread and salad dressing to healthy adult men and women.
abstract: OBJECTIVE
  The safety and tolerability of three levels of plant sterol-esters administered in reduced-fat spread and salad dressing vs. control products were evaluated in this randomized, double-blind, four-arm parallel study.
  
  
  METHODS
  Eighty-four free-living men and women consumed reduced-fat spread and salad dressing providing 0.0 g/day (n = 21), 3.0 g/day (n = 21), 6.0 g/day (n = 19) or 9.0 g/day (n = 23) of phytosterols as esters for an eight-week treatment period.
  
  
  RESULTS
  Side effects did not differ among the groups during the study, and there were no study product-related serious adverse events. There were no changes in clinical laboratory values in response to phytosterol intake. Blood concentrations of all fat-soluble vitamins remained within normal reference ranges, and there were no differences in serum vitamin responses among the four groups. Alpha- and trans-beta-carotene levels were reduced in the 9.0 g/day group vs. control (p < 0.05), but all carotenoid values remained within normal ranges throughout the study. All groups receiving phytosterols had significant increases in serum campesterol vs. control (p < 0.001), but beta-sitosterol responses did not differ from control. Total, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol responses did not differ significantly among the groups. The total:HDL cholesterol response in the 9.0 g/day group was significantly different from the control group response (-9.6% vs. 2.6%, p < 0.05). A median increase of 7.8% in serum triglycerides was observed in the control group, which differed significantly from the response in the 3.0 g/day arm (-13.3%, p < 0.05).
  
  
  CONCLUSIONS
  The results of this study indicate that phytosterol esters are well tolerated and show no evidence of adverse effects at a daily intake of up to 9.0 g of phytosterols for eight weeks.
authors.affiliation: Chicago Center for Clinical Research, Illinois 60610, USA.
authors.forename: M H
authors.initials: MH
authors.lastname: Davidson
authors.forename: K C
authors.initials: KC
authors.lastname: Maki
authors.forename: D M
authors.initials: DM
authors.lastname: Umporowicz
authors.forename: K A
authors.initials: KA
authors.lastname: Ingram
authors.forename: M R
authors.initials: MR
authors.lastname: Dicklin
authors.forename: E
authors.initials: E
authors.lastname: Schaefer
authors.forename: R W
authors.initials: RW
authors.lastname: Lane
authors.forename: J R
authors.initials: JR
authors.lastname: McNamara
authors.forename: J D
authors.initials: JD
authors.lastname: Ribaya-Mercado
authors.forename: G
authors.initials: G
authors.lastname: Perrone
authors.forename: S J
authors.initials: SJ
authors.lastname: Robins
authors.forename: W C
authors.initials: WC
authors.lastname: Franke
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D001835:Body Weight; D002338:Carotenoids / Q000097:blood; D003402:Creatine Kinase / Q000097:blood; D004032:Diet; D015930:Diet Records; D004041:Dietary Fats / Q000008:administration & dosage; D004311:Double-Blind Method; D004951:Esterification; D005260:Female; D005502:Food; D006801:Humans; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010840:Phytosterols / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D014815:Vitamins / Q000097:blood
chemical_list: D004041:Dietary Fats; D008055:Lipids; D010840:Phytosterols; D014815:Vitamins; D002338:Carotenoids; D000410:Alanine Transaminase; D003402:Creatine Kinase