Three arms, double-blind, non-inferiority, randomized clinical study testing the lipid-lowering effect of a novel dietary supplement containing red yeast rice and artichoke extracts compared to Armolipid Plus(®) and placebo

INTRODUCTION: There is growing interest in head-to-head comparison between different lipid-lowering nutraceuticals. The aim of our study was to test the lipid-lowering effect of dietary supplementation with low-dose monacolins from red yeast rice (2.8 mg per daily dose) combined with berberine (Armolipid Plus(®)) or highly standardized artichoke extract versus placebo. MATERIAL AND METHODS: 60 overall healthy adult volunteers with polygenic hypercholesterolemia (baseline low-density lipoprotein cholesterol (LDL-C) = 160.2 ±9.2 mg/dl) were enrolled in a 3-arm, double-blind, non-inferiority, randomized, parallel-group clinical trial. After 4-week diet standardization, enrolled individuals were randomized to be treated for 8 weeks with red yeast rice and highly standardized artichoke extracts (ATC group), Armolipid Plus(®), or placebo. RESULTS: At the enrolment visit, LDL-C values were similar in the compared groups. After 8 weeks, all actively treated subjects experienced significant improvements in baseline total cholesterol (TC), LDL-C and apolipoprotein B (Apo-B) (all p < 0.01) (ATC group: TC = –18.9%, LDL-C = –26.7% (placebo-corrected: –12.4%), Apo-B = –19.6%; Armolipid Plus(®): TC = –18.4%, LDL-C = –25.8% (placebo-corrected: –12.1%), Apo-B = –23.2%; placebo: TC = –6.2%, LDL-C = –8%, Apo-B = –8.4%). Participants in the ATC group attained significantly lower body mass index (BMI) values (–2.1%), while individuals treated with Armolipid Plus(®) showed improvements in baseline high-density lipoprotein cholesterol (HDL-C) (+8.7%) and triglyceride (TG) (+17.5%) levels. Finally, baseline hepatic steatosis index (HSI) values significantly decreased in both actively treated groups (by –2.4% and –2.4% in ATC and in Armolipid Plus(®), respectively). CONCLUSIONS: Patients with polygenic hypercholesterolemia experienced a significant improvement in several cardiovascular risk factors in both ATC and Armolipid Plus(®) groups.