Safety and Tolerability of Esterified Phytosterols Administered in Reduced-Fat Spread and Salad Dressing to Healthy Adult Men and Women

Autor: Davidson, Michael H., Maki, Kevin C., Umporowicz, Denise M., Ingram, Kate A., Dicklin, Mary R., Schaefer, Ernst, Lane, Richard W., McNamara, Judith R., Ribaya-Mercado, Judy D., Perrone, Gayle, Robins, Sander J., Franke, William C.
Zdroj: Journal of the American College of Nutrition; August 2001, Vol. 20 Issue: 4 p307-319, 13p
Abstrakt: Objective/Design: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-β-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 β-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).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.
Databáze: Supplemental Index