The objective of the study was to investigate whether different initial baseline cholesterol levels modulate the efficacy of a spread enriched with plant sterol-esters (PS) in lowering blood cholesterol in a Japanese population consuming their usual diet. Healthy adults with a mean age of 45 y and mean plasma total cholesterol (TC) level of 6.5 mmol/L were recruited to participate in a double-blind trial comprised of a run-in period of 1 wk, followed by two intervention periods of 3 wks in a 2 x 2 crossover design and a post-trial follow-up of 3 wk. Volunteers consumed two spreads, one enriched with PS (12 g/100 g plant sterols) and a control spread not fortified with PS. Recommended spread intake was 15 g/d. Effects on plasma lipids, lipoproteins, beta-carotene and vitamins A and E were assessed. Plasma TC and LDL cholesterol (LDL-C) concentrations were 5.8 and 9.1% lower, respectively, when subjects consumed the PS spread than when they consumed the control spread (P < 0.001). Subjects were divided into two groups [normal and mildly cholesterolemic (TC <5.7 mmol/L) and hypercholesterolemic (TC >/= 5.7 mmol/L)]. Reductions (P < 0.001) in TC and LDL-C due to treatment in the former group were 4.9 and 7.9%, respectively. In the hypercholesterolemic group, the reductions (P < 0.001) were 7.1 and 10.6%, respectively. The decreases did not differ between normal/mildly cholesterolemic and hypercholesterolemic subjects. Plasma apolipoprotein B (apoB) and remnant-like particle (RLP) cholesterol (RLP-C) concentrations were lower when subjects consumed the PS spread (44.3 g/L) than the control spread (49.7 g/L). Plasma beta-carotene concentration was lower (P < 0.001) in subjects consuming the PS spread than in the control. Changes in plasma vitamins A and E levels did not differ after intake of the PS and control spreads. In conclusion, consumption of a PS-enriched spread effectively lowered plasma TC, LDL-C, apoB and RLP-C regardless of baseline plasma TC at an intake of 1.8 g/d of plant sterols.