Randomised controlled trial of use by hypercholesterolaemic patients of a vegetable oil sterol-enriched fat spread

• Published in: Atherosclerosis Vol. 156; no. 2; pp. 329 - 337
• Main Authors: Neil, H.A.W., Meijer, G.W., Roe, L.S.
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier Ireland Ltd 01.06.2001; Elsevier
• Subjects: Adult; Biological and medical sciences; Cholesterol, HDL - analysis; Cholesterol, LDL - analysis; Chromatography, Gas; Confidence Intervals; Cross-Over Studies; Diet; Disorders of blood lipids. Hyperlipoproteinemia; Double-Blind Method; Familial hypercholesterolaemia; Female; Humans; Hypercholesterolaemia; Hypercholesterolemia - diagnosis; Hypercholesterolemia - diet therapy; Hypercholesterolemia - drug therapy; Hyperlipoproteinemia Type II - diet therapy; Hyperlipoproteinemia Type II - drug therapy; Hypolipidemic Agents - administration & dosage; Male; Margarine; Margarine-enriched; Medical sciences; Metabolic diseases; Middle Aged; Phytosterols; Plant Oils; Probability; Randomised controlled trial; Margarine-enriched; Hypercholesterolaemia; Familial hypercholesterolaemia; Phytosterols; Randomised controlled trial; Human; Balanced diet; Hypercholesterolemia; Diet therapy; Metabolic diseases; Lipids; Hyperlipoproteinemia; Dyslipemia; Vegetal oil; Hereditary
• ISSN: 0021-9150; 1879-1484
• DOI: 10.1016/S0021-9150(00)00653-5

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 hyperlipoprotienaemia. 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.