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 (10Â mg), phytosterols (800Â mg), and l-tyrosol (5Â 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 (â16.3% vs 9.9%, PÂ <Â 0.001 always), LDL-C (â23.4% vs â13.2%, PÂ <Â 0.001 always), and hepatic steatosis index (â2.8%, PÂ <Â 0.01 vs â1.8%, PÂ <Â 0.05). Moreover, ALT (â27.7%, PÂ <Â 0.001), AST (â13.8%, PÂ =Â 0.004), and serum uric acid (â12.3%, PÂ =Â 0.005) were reduced by the tested nutraceutical compound both compared to randomization and to placebo, which did not affect these parameters (PÂ <Â 0.01 for all). Regarding the hemodynamic parameters, there was a decrease of systolic blood pressure (â5.6%) with the active treatment not observed with placebo (PÂ <Â 0.05 vs baseline and placebo) and endothelial reactivity improved, too (â13.2%, PÂ <Â 0.001 vs baseline). Consequently, the estimated 10-year cardiovascular risk score improved by 1.19% (SE 0.4%) (PÂ =Â 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.
Cicero, A.F.G., Fogacci, F., Bove, M., Veronesi, M., Rizzo, M., Giovannini, M., et al. (2017). 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. ADVANCES IN THERAPY, 34(8), 1966-1975 [10.1007/s12325-017-0580-1].
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
Cicero, Arrigo F. G.;Bove, Marilisa;Veronesi, Maddalena;Giovannini, Marina;Borghi, Claudio
2017
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 (10Â mg), phytosterols (800Â mg), and l-tyrosol (5Â 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 (â16.3% vs 9.9%, PÂ <Â 0.001 always), LDL-C (â23.4% vs â13.2%, PÂ <Â 0.001 always), and hepatic steatosis index (â2.8%, PÂ <Â 0.01 vs â1.8%, PÂ <Â 0.05). Moreover, ALT (â27.7%, PÂ <Â 0.001), AST (â13.8%, PÂ =Â 0.004), and serum uric acid (â12.3%, PÂ =Â 0.005) were reduced by the tested nutraceutical compound both compared to randomization and to placebo, which did not affect these parameters (PÂ <Â 0.01 for all). Regarding the hemodynamic parameters, there was a decrease of systolic blood pressure (â5.6%) with the active treatment not observed with placebo (PÂ <Â 0.05 vs baseline and placebo) and endothelial reactivity improved, too (â13.2%, PÂ <Â 0.001 vs baseline). Consequently, the estimated 10-year cardiovascular risk score improved by 1.19% (SE 0.4%) (PÂ =Â 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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.