Efficacy of a multicomponent nutraceutical on the normalization of liver functional parameters in patients with NAFLD: a double blind, randomized, clinical trial
Corresponding AuthorArrigo F.G. Cicero
Department of Medicine and Surgery Sciences, University of Bologna, Bologna, Italy
A B S T R A C T
Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in Western countries. The main preventive/therapeutic tool of NAFLD is currently the improvement of lifestyle. The purpose of this study is to evaluate the impact of a combined nutraceutical approach on the clinical and laboratory features of NAFLD patients. We consecutively enrolled 80 NAFLD patients in a double-blind, placebo-controlled, randomized clinical trial. After a 4 weeks stabilization diet period, we randomized them to assume a combined multivitamin/multimineral/botanical nutraceutical (MetaclearTM) 2 tablets per day or an identical placebo for 3 months. Patients were rechecked after further 30 days. Liver parameters significantly improved in the combined nutraceutical treated subjects. In particular, in a generalized linear mixed model with Fatty Liver Index (FLI) as dependent variable a significant period by treatment effect was observed (F-value = 22.5, p<0.001). For the patients treated with the combined nutraceutical, FLI decreased with on average 11.9 units and 13.6 units at the end of treatment and the follow-up visit compared to baseline, respectively. The decrease in FLI from baseline to the end of treatment and to follow-up was on average 5.9 units higher (95%C 3.3-8.4, p<0.001) and 8.6 units higher (95%CI 6.0-11.1, p<0.001) for the combined nutraceutical treated group in comparison to the placebo group, respectively. The short-term treatment with the combined nutraceutical has been associated with a significant improvement of NAFLD biomarkers.
Article TypeResearch Article
Publication historyReceived: Sat 02, Feb 2019
Accepted: Fri 08, Mar 2019
Published: Mon 18, Mar 2019
Copyright© 2021 Arrigo F.G. Cicero. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Hosting by Science Repository. All rights reserved.