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

摘要

Abstract 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 ? P ? P ? P ? P ? 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 ? P ? P ? 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.