Minimal Effective Dose of Plant Sterol on Serum Cholesterol Concentration in Japanese Subjects and Safety Evaluation of Plant Sterol Supplemented in Mayonnaise

Abstract

For examination of the title parameters, study was made in which forty healthy male subjects (serum cholesterol concentration 170-309 mg/dL) were fed 0, 200, 400, 600, or 800 mg/day of free plant sterol supplemented in mayonnaise for 4 consecutive weeks. Only the 800 mg/day group significantly reduced serum cholesterol by the paired t-test (Exp.1). Thirty-two healthy males (serum cholesterol, 184-285 mg/dL) were made to consume plant sterol as ester at 0, 800, 1600, or 2400 mg/day. In all cases at more than 800 mg/day reduction in serum cholesterol was noted though without significant difference with paired t-test results (Exp.2). Subsequent to the mayonnaise consumption, normal diets were resumed for a period of 4 weeks. Total cholesterol showed original values at the end of this period. Plant sterol is thus shown to be a dietary component capable of reducing cholesterol by these results. Fifteen healthy subjects (males 10, females 5) were made to consume free plant sterol supplemented in mayonnaise at 2400 mg/day for 4 consecutive weeks. No change in serum vitamin A or vitamin E levels was observed at 2400 mg consumption. At 2400 mg, a significant increase in serum β-sitosterol was noted though it was markedly less than β-sitosterolemia. Clinical trial results, in all cases, were normal (Exp.3). The minimal effective dose of plant sterol on serum cholesterol concentration would thus appear to be 800 mg/day. At 2400 mg/day in mayonnaise, physiological and biochemical safety markers in serum would not undergo abnormal change.