Objectives: To determine the efficacy on plasma cholesterol-lowering of plant sterol esters or non-esterified stanols eaten within low-fat foods as well as margarine. Design: Randomised, controlled, single-blind study with sterol esters and non-esterified plant stanols provided in breakfast cereal, bread and spreads. Study 1 comprised 12 weeks during which sterol esters (2.4 g) and stanol (2.4 g) -containing foods were eaten during 4 week test periods of cross-over design following a 4 week control food period. In Study 2, in a random order cross-over design, a 50% dairy fat spread with or without 2.4 g sterol esters daily was tested. Subjects: Hypercholesterolaemic subjects; 22 in study 1 and 15 in study 2. Main outcome measures: Plasma lipids, plasma sterols, plasma carotenoids and tocopherols. Results: Study 1 -median LDL cholesterol was reduced by the sterol esters (713.6%; P < 0.001 by ANOVA on ranks; P < 0.05 by pairwise comparison) and by stanols (78.3%; P ¼ 0.003, ANOVA and < 0.05 pairwise comparison). With sterol esters plasma plant sterol levels rose (35% for sitosterol, 51% for campesterol; P < 0.001); plasma lathosterol rose 20% (P ¼ 0.03), indicating compensatory increased cholesterol synthesis. With stanols, plasma sitosterol fell 22% (P ¼ 0.004), indicating less cholesterol absorption. None of the four carotenoids measured in plasma changed significantly. In study 2, median LDL cholesterol rose 6.5% with dairy spread and fell 12.2% with the sitosterol ester fortified spread (P ¼ 0.03 ANOVA and < 5% pairwise comparison). Conclusion: 1. Plant sterol esters and non-esterified stanols, two-thirds of which were incorporated into low-fat foods, contributed effectively to LDL cholesterol lowering, extending the range of potential foods. 2. The LDL cholesterol-raising effect of butter fat could be countered by including sterol esters. 3. Plasma carotenoids and tocopherols were not reduced in this study. Sponsorship: Meadow Lea Foods, Australia. Descriptors: sterolesters; sitostanol; low-fat foods; cholesterol European Journal of Clinical Nutrition (2001Nutrition ( ) 55, 1084Nutrition ( -1090 Introduction Plant stanol and sterol esters incorporated within spreads have been shown to augment the low density lipoprotein cholesterol lowering effect of other strategies. Alone, in dosages of around 2 g daily, stanol or unhydrogenated sterol esters lower LDL cholesterol by about 10% or more (Miettinen et al, 1995;Westrate & Meijer, 1998;Gylling & Miettinen, 1994). When added to a cholesterollowering diet, sitostanol ester-containing margarine reduces LDL cholesterol by at least a further 5% Andersson et al, 1999). Each of these studies had provided sterols in the form of esters and within margarine.Non-esterified or free sterols have also been shown to be effective by a 17% reduction in LDL cholesterol during treatment with a high dose of a soy sterol suspension, although lesser amounts (3 g tall oil sterols, mainly sitosterol) were also effective (Lees et al, 1977). The effect of non-esterified sitostanol is les...