Short-Term Effects of a Combined Nutraceutical on Lipid Level, Fatty Liver Biomarkers, Hemodynamic Parameters, and Estimated Cardiovascular Disease Risk: A Double-Blind, Placebo-Controlled Randomized Clinical Trial

INTRODUCTION: There is a growing interest in nutraceuticals improving cardiovascular risk factor levels and related organ damage. METHODS: This double-blind, placebo-controlled randomized clinical trial aims to compare the effect of a combined nutraceutical containing red yeast rice (10 mg), phytosterols (800 mg), and l-tyrosol (5 mg) on lipid profile, blood pressure, endothelial function, and arterial stiffness in a group of 60 patients with polygenic hypercholesterolemia resistant to Mediterranean diet. RESULTS: After 8 weeks of treatment, when compared to the placebo group, the active treated patients experienced a more favorable percentage change in total cholesterol (−16.3% vs 9.9%, P < 0.001 always), LDL-C (−23.4% vs −13.2%, P < 0.001 always), and hepatic steatosis index (−2.8%, P < 0.01 vs −1.8%, P < 0.05). Moreover, ALT (−27.7%, P < 0.001), AST (−13.8%, P = 0.004), and serum uric acid (−12.3%, P = 0.005) were reduced by the tested nutraceutical compound both compared to randomization and to placebo, which did not affect these parameters (P < 0.01 for all). Regarding the hemodynamic parameters, there was a decrease of systolic blood pressure (−5.6%) with the active treatment not observed with placebo (P < 0.05 vs baseline and placebo) and endothelial reactivity improved, too (−13.2%, P < 0.001 vs baseline). Consequently, the estimated 10-year cardiovascular risk score improved by 1.19% (SE 0.4%) (P = 0.01) in the nutraceutical-treated patients. CONCLUSION: The tested nutraceutical association is able to improve the positive effects of a Mediterranean diet on a large number of CV risk factors and consequently of the estimated CV risk. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02492464. FUNDING: IBSA Farmaceutici.