title: Randomised controlled trial of use by hypercholesterolaemic patients of a vegetable oil sterol-enriched fat spread.
abstract: Plant sterols may be a useful additive therapy in the treatment of hypercholesterolaemic patients. The purpose of this study was to determine the effect of a fat spread enriched with vegetable oil sterols on plasma lipid, lipoprotein and apolipoprotein concentrations. A randomised double blind placebo-controlled crossover trial with two consecutive periods of 8 weeks was conducted. 30 patients with heterozygous familial hypercholesterolaemia treated concurrently with an HMG-CoA reductase inhibitor (statin) and 32 patients with type IIa primary hypercholesterolaemia with a total cholesterol concentration >6.5 mmol/l not taking lipid-lowering drug therapy were recruited from a hospital lipid clinic. The active treatment was a fortified fat spread (25 g/day) providing 2.5 g of plant sterols. The control spread was indistinguishable in taste and appearance. Comparison at the end of the two 8-week trial periods showed a statistically significant reduction in total and LDL-cholesterol with use of the fortified spread but the results were confounded by a carry-over effect, which was partly explained by changes in the background diet. Because a carry-over effect was present, further analyses were restricted to the parallel arms of the first treatment period and were conducted on an intention to treat basis. After 4 weeks, LDL-cholesterol had decreased by 0.04 mmol/l ([0.8%] 95% confidence interval -0.44-0.37 NS) in the placebo group and decreased by -0.76 mmol/l ([15.0%] 95% CI -1.03--0.48, P<0.0001) in the active treatment group. After 8 weeks, the corresponding results were 0.0 mmol/l ([0.0%] 95% CI -0.26-0.24 NS) and -0.51 mmol/l ([10.0%] 95% CI -0.73--0.29 P<0.0001). There were no significant changes in apolipoprotein AI or B concentrations in the placebo group, but there was a small but statistically significant increase in apolipoprotein AI and a decrease in apolipoprotein B in the active treatment group. HDL cholesterol and triglyceride concentrations were unchanged. There was no difference in response between patients with statin-treated familial hypercholesterolaemia and patients with type IIa hyperlipoproteinaemia. We conclude that a fortified fat spread enriched with vegetable oil sterols reduces LDL-cholesterol by 10-15% with no difference in response between hypercholesterolaemic patients prescribed statins and those not taking lipid-lowering drug therapy.
authors.affiliation: Division of Public Health and Primary Health Care, Institute of Health Sciences, University of Oxford, Old Road, Headington, OX3 7LF, Oxford, UK. andrew.neil@dphpc.ox.ac.uk
authors.forename: H A
authors.initials: HA
authors.lastname: Neil
authors.forename: G W
authors.initials: GW
authors.lastname: Meijer
authors.forename: L S
authors.initials: LS
authors.lastname: Roe
mesh_terms: D000328:Adult; D008076:Cholesterol, HDL / Q000032:analysis*; D008078:Cholesterol, LDL / Q000032:analysis*; D002849:Chromatography, Gas; D016001:Confidence Intervals; D018592:Cross-Over Studies; D004032:Diet; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000175:diagnosis / Q000178:diet therapy / Q000188:drug therapy; D006938:Hyperlipoproteinemia Type II / Q000178:diet therapy* / Q000188:drug therapy; D000960:Hypolipidemic Agents / Q000008:administration & dosage; D008297:Male; D008383:Margarine; D008875:Middle Aged; D010938:Plant Oils; D011336:Probability
chemical_list: D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D000960:Hypolipidemic Agents; D010938:Plant Oils; D008383:Margarine