TY - JOUR
AR - JFNM-2018-1-104
TI - Efficacy of a multicomponent nutraceutical on the normalization of liver functional parameters in patients with NAFLD: a double blind, randomized, clinical trial
AU -  Federica , Fogacci
AU - Alessandro , Colletti
AU - An-Katrien , Vynckier
AU - Arrigo F.G. , Cicero
AU - Claudio , Borghi
AU - Laura, Garcia-Molina
AU - Maddalena , Veronesi
AU - Maurizio, Salamone
AU - Mieke Van Den , Driessche
JO - Journal of Food Nutrition and Metabolism
PY - 2018
DA - Mon 18, Mar 2019
SN - 2674-2411
DO - http://dx.doi.org/10.31487/j.JFNM.2018.01.004
UR - https://www.sciencerepository.org/efficacy-of-a-multicomponent-nutraceutical-on-the-normalization-of-liver-functional-parameters-in-patients-with-NAFLD-a-double-blind-randomized-clinical-trial_JFNM-1-104 
KW -  NAFLD, fatty liver, nutraceuticals, herbal supplements, dietary supplements, clinical trial
AB - 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.