Effect of red yeast rice combined with antioxidants on lipid pattern, hs-CRP level, and endothelial function in moderately hypercholesterolemic subjects

Placebo-controlled short-term trial in moderately hypercholesterolemic adults in Italy. In the active monacolins arm, 12 participants were analyzed at baseline (mean age 53.65 years; 5 men and 7 women); they were 18 to 70 years old, nonsmoking, pharmacologically untreated, in primary prevention, with LDL-C 130 to 190 mg/dL and mean BMI 26.8.

Oral red yeast rice nutraceutical providing 10 mg monacolins from Monascus purpureus plus antioxidants: green tea dry extract 100 mg, coenzyme Q10 20 mg, astaxanthin 2 mg, resveratrol 20 mg, and quercetin 50 mg. The active regimen was given for 4 weeks per treatment period and was compared with placebo.

The red yeast rice plus antioxidant regimen produced better short-term improvements than placebo in lipids, inflammation, and endothelial function markers. Compared with placebo, active treatment reduced total cholesterol by 43.5 mg/dl versus 12.1 mg/dl, LDL-C by 37.5 mg/dl versus 2.1 mg/dl, non-HDL-C by 45.7 mg/dl versus 13.5 mg/dl, apoB by 11.8 mg/dl versus 0.2 mg/dl, and hs-CRP by 0.05 mg/l versus an increase of 0.04 mg/l; pulse volume changes increased by 11.6% versus a 4.3% decrease. The authors concluded that the 10 mg monacolin nutraceutical safely lowers cholesterolemia, hs-CRP, and vascular remodeling markers in the short term. Two patients reported mild myalgia at the start of treatment, and no dropouts occurred because of adverse events.

The active arm was very small (n=12) and treatment lasted only 4 weeks, limiting precision and long-term safety assessment. The study was conducted at a single Italian center in moderately hypercholesterolemic adults, so generalizability is limited. Several lifestyle measures were also advised, which may complicate attribution of all effects to the supplement alone.