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 TrialReportar como inadecuado




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Advances in Therapy

pp 1–10

First Online: 07 July 2017Received: 28 May 2017

Abstract

IntroductionThere is a growing interest in nutraceuticals improving cardiovascular risk factor levels and related organ damage.

MethodsThis 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.

ResultsAfter 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.

ConclusionThe 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 registrationClinicalTrials.gov identifier NCT02492464.

FundingIBSA Farmaceutici.

KeywordsCardiovascular disease risk Dietary supplements Endothelial dysfunction l-Tyrosol Nutraceuticals Red yeast rice Phytosterols Enhanced contentTo view enhanced content for this article go to http:-www.medengine.com-Redeem-FAD8F0603046763F.

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Autor: Arrigo F. G. Cicero - Federica Fogacci - Marilisa Bove - Maddalena Veronesi - Manfredi Rizzo - Marina Giovannini - Claudio

Fuente: https://link.springer.com/







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