Effects of a nutraceutical combination of fermented red rice, liposomal berberine, and curcumin on lipid and inflammatory parameters in patients with mild-to-moderate hypercholesterolemia: an 8-week, open-label, single-arm pilot study

INTRODUCTION: The present open-label, single-arm pilot study sought to evaluate the effects of a nutraceutical combination containing fermented red rice, liposomal berberine, and curcumin on lipid and inflammatory parameters in patients with mild-to-moderate hypercholesterolemia. MATERIAL AND METHODS: Forty patients with mild-to-moderate hypercholesterolemia received the nutraceutical combination containing fermented red rice, liposomal berberine, and curcumin, once a day for 8 weeks. The study outcomes included changes from baseline in lipid (total cholesterol (TC), low-density-lipoprotein cholesterol (LDL-C), oxidized low-density lipoprotein (oxLDL), high-density-lipoprotein cholesterol (HDL-C), and triglycerides (TG)) and inflammatory parameters (high-sensitivity C-reactive protein (hs-CRP) and tumor necrosis factor-α (TNF-α)). RESULTS: Compared with baseline, the nutraceutical combination produced a statistically significant reduction of TC (–20.4%, p < 0.05), LDL-C (–27.6%, p < 0.05), oxLDL (–23.2%, p < 0.05), and TG (–17.9%, p < 0.05). We also observed a reduction from baseline for hs-CRP (–15.4%, p < 0.05) and TNF-α (–14.3%, p < 0.05). The treatment was well tolerated and none of the patients discontinued treatment due to adverse effects. No cases of myalgia or musculoskeletal system disorders were observed. CONCLUSIONS: The nutraceutical combination of fermented red rice, liposomal berberine, and curcumin improves lipid profile and reduces markers of inflammation in low-risk dyslipidemic patients, with potential implications for primary prevention of cardiovascular disease.