Background: The number of hypercholesterolemic individuals who do not meet their cholesterol recommended targets is inappropriately high. The use of plant sterol-enriched foods could help in this clinical setting.
Aim of the study: To evaluate the efficacy and side effects of plant sterol-enriched fermented milk in reducing LDL-cholesterol and increasing the number of patients who attain their therapeutic targets.
Methods: This was a multicentre, randomised, double-blind, placebo-controlled, parallel clinical trial. Eighty-three hypercholesterolemic patients that were not at therapeutic goals were studied. The patients received one 100 ml serving of either plain (control) low-fat or phytosterol enriched (1.6 g of free sterol equivalents) drinkable yogurt per day along with the main meal for 42 days. The principal variables were variation on LDL cholesterol (LDL-C) concentration and the number of patients achieving therapeutic goals after intervention.
Results: Patients on phytosterols attained an average LDL-C reduction of more than 10% (12.2% after 3 weeks; 10.6% after 6 weeks) (P = 0.001; 95% CI: 4.03-19.00) regardless of statin therapy compared to the control group. About 50% of the subjects on phytosterols, as compared to 20% of controls, attained their LDL-C target values (<3.3 or <2.6 mmol/l for primary and secondary prevention, respectively) at the end of the study (P < 0.001). HDL-cholesterol (HDL-C) did not change and triglycerides (TG) were decreased by 14% (P < 0.018). The plasma sterols/total cholesterol ratio increased.
Conclusions: Plant sterol-enriched fermented milk significantly reduced LDL-C and increased the number of moderately hypercholesterolemic patients achieving therapeutic targets.