Effect of a short-term dietary supplementation with phytosterols, red yeast rice or both on lipid pattern in moderately hypercholesterolemic subjects: a three-arm, double-blind, randomized clinical trial

Three parallel-arm, double-blind, randomized clinical trial in 90 adults with moderate hypercholesterolemia (LDL-C 130-190 mg/dL), non-smokers, untreated, in primary prevention of cardiovascular disease; ages 18-70; baseline characteristics similar across groups.

Phytosterols 800 mg; Red yeast rice standardized to contain 5 mg monacolins; both combined; duration 8 weeks; delivered as indistinguishable liquid sticks (oral).

Phytosterols alone did not significantly change lipid parameters after 8 weeks. Red yeast rice alone reduced total cholesterol by 16.1%, LDL-C by 20.5%, and ApoB by 14.4%. Combined phytosterols and red yeast rice reduced total cholesterol by 18.5%, LDL-C by 23.0%, and ApoB by 19.0%. Group 2 and group 3 both differed significantly from group 1 (P<0.05); LDL-C reduction was higher with the combination than with red yeast rice alone (−6.5 ± 1.2% difference; P<0.05). The additive lipid-lowering effect suggests a clinically meaningful LDL-C reduction in mildly hypercholesterolemic individuals, with good short-term tolerability (no adverse-event-related dropouts).

Small per-group sample after excluding non-adherent participants; no pure placebo group; short duration (8 weeks); no measurements of cholesterol absorption or synthesis markers; limited generalizability to mildly hypercholesterolemic, non-smoking adults.