Safety of Phytosterol Esters

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

Michael H. Davidson, MD, Kevin C. Maki, PhD, Denise M. Umporowicz, MS, Kate A. Ingram, MPH, RD, Mary R. Dicklin, PhD, Ernst Schaefer, MD, Richard W. Lane, PhD, Judith R. McNamara, MT, Judy D. Ribaya-Mercado, PhD, Gayle Perrone, MBA, Sander J. Robins, MD, and William C. Franke, PhD

Chicago Center for Clinical Research, Chicago, Illinois (M.H.D., K.C.M., D.M.U., K.A.I., M.R.D.), Lipton, Englewood Cliffs, New Jersey (R.W.L., W.C.F.), Boston VA Medical Center (S.J.R.), Tufts University (E.S., J.R.M., J.D.R.-M., G.P.), Boston, Massachusetts []

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–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 -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.

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