A low-fat spread with added plant sterols and fish omega-3 fatty acids lowers serum triglyceride and LDL-cholesterol concentrations in individuals with modest hypercholesterolaemia and hypertriglyceridaemia

PURPOSE: The primary and secondary objectives were to investigate the triglyceride (TG) and LDL-cholesterol (LDL-C) lowering effects of a spread with added plant sterols (PS) and fish oil as compared to a placebo spread. METHODS: This study had a randomized, double-blind, placebo-controlled, parallel group design with two intervention arms. Following a 2-week placebo run-in period, 260 healthy individuals with modestly elevated blood TG (≥ 1.4 mmol/L) and LDL-C (≥ 3.4 mmol/L) concentrations consumed either the placebo or intervention spread for 4 weeks. The intervention spread contained 2.0 g/day PS and 1.0 g/day eicosapentaenoic acid (EPA) + docosahexanoic acid (DHA) from fish oil. Fasting serum lipids and apolipoproteins (Apo) (exploratory) were measured at the end of the run-in and intervention phases. RESULTS: Four-week consumption of the intervention spread resulted in significantly lower TG (− 10.6%, 95% CI − 16.0 to − 4.9%; P < 0.001) and LDL-C concentrations (− 5.2%; 95% CI − 7.8 to − 2.4%) as compared to placebo. Total cholesterol (− 3.9%; 95% CI − 6.1 to − 1.5%), non-HDL-C (− 5.4%; 95% CI − 8.1 to − 2.7%), remnant-cholesterol (− 8.1%; 95% CI − 3.4 to − 12.5%), ApoAII (− 2.9%; 95% CI − 5.5 to − 0.2%), ApoCIII (− 7.7%; 95% CI − 12.1 to − 3.1%) and ApoB (− 3.2%; 95% CI − 5.9 to − 0.4%) concentrations were also significantly lower, as compared to placebo. No significant treatment effects were found for HDL-cholesterol, ApoAI, ApoCII, Apo E or ApoB/ApoAI. CONCLUSIONS: Four-week consumption of the intervention spread led to significant and clinically relevant decreases in serum TG, LDL-C and other blood lipid concentrations. The study was registered at clinicaltrials.gov (NCT 02728583). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00394-018-1706-1) contains supplementary material, which is available to authorized users.