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-arm, double-blind randomized clinical trial in 90 moderately hypercholesterolemic adults in primary cardiovascular prevention, recruited in Bologna, Italy. Eligible participants were 18 to 70 years old, non-smokers, not taking lipid-lowering medication, and had LDL-C 130 to 190 mg/dL on repeated checks; they also received advice to follow a Mediterranean-style diet and lifestyle guidance during the 8-week study.

Participants received indistinguishable liquid sticks for 8 weeks containing either phytosterols 800 mg, red yeast rice standardized to 5 mg monacolins from Monascus purpureus, or the two products together. The study compared these three active regimens in a double-blind randomized design.

The combination of phytosterols plus red yeast rice produced the most consistent lipid-lowering effect and was well tolerated over 8 weeks. Phytosterols alone did not produce significant lipid changes, whereas red yeast rice significantly reduced total cholesterol, LDL-C, and ApoB, and the combination produced larger reductions, including LDL-C -45.2 mg/dL and ApoB -19.3 mg/dL. Compared with phytosterols alone, LDL-C and ApoB changes were significantly better with red yeast rice and with the combination; LDL-C change was also significantly greater with the combination than with red yeast rice alone, with a reported between-group difference of -6.5 ± 1.2% (p < 0.05). No patient dropped out because of adverse events, supporting the authors' conclusion that the combined regimen may be a useful short-term option for primary prevention in mildly to moderately hypercholesterolemic patients.

The trial was short, lasting only 8 weeks, so it does not address durability of lipid lowering or long-term safety. Sample sizes were small, and the protocol-specified efficacy analysis excluded noncompliant participants who took less than 90% of doses, reducing the analyzed numbers further. The study used active comparators rather than a placebo arm and was conducted at a single center in Italy, which limits generalizability.