Safety and tolerability of esterified phytosterols administered in reduced-fat spread and salad dressing to healthy adult men and women

Objective/Design: The safety and tolerability of three levels of plant ster ol-esters administered in reduced-fat spread and salad dressing vs. control products were evaluated in this randomized, double-blind, four-arm paralle l 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-w eek 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. Bl ood concentrations of all fat-soluble vitamins remained within normal refer ence ranges, and there were no differences in serum vitamin responses among the four groups. Alpha- and trans-beta -carotene levels were reduced in th e 9.0 g/day group vs. control (p < 0.05), but all carotenoid values remaine d within normal ranges throughout the study. All groups receiving phytoster ols had significant increases in serum campesterol vs. control (p < 0.001), but beta -sitosterol responses did not differ from control. Total, low-den sity lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol respo nses did not differ significantly among the groups. The total:HDL cholester ol response in the 9.0 g/day group was significantly different from the con trol group response (-9.6% vs. 2.6%, p < 0.05). A median increase of 7.8% i n serum triglycerides was observed in the control group, which differed sig nificantly from the response in the 3.0 g/day arm (-13.3%, p < 0.05). Discussion: 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.