MAST4HEALTH study

Background and aims: Non-alcoholic fatty liver disease (NAFLD) is one of the most common liver diseases in Western countries. It encompasses a wide spectrum of liver pathologies from simple steatosis to more progressive disease, fibrosis, cirrhosis, and even hepatocellular carcinoma. There is no approved therapy for NAFLD. The aim of this study was to explore the effectiveness of a Mastiha supplement as a non-pharmacological intervention for managing NAFLD.Methods: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. ? total of 98 NAFLD patients were enrolled in three countries (Greece, Italy, Serbia) and were randomly allocated to either the Mastiha or the Placebo group for 6 months. NAFLD and its severity were assessed by MRI-PDFF scanning and the sensitive LiverMultiScan technique. Medical, anthropometric, lifestyle assessment, biochemical, metabolomic and microbiota markers have also been assessed.Results: We detected a very significant increase of triterpenic acid sulphate levels within the Mastiha group compared to the Placebo in the post treatment (P value=2.43e-06). The Bray-Curtis dissimilarity index between pre- and post-treatment gut microbiota communities was significantly higher in the Mastiha group (P value=0.006). Two lipid subclasses (Lysophosphatidylcholines (LysoPC) 18.1 chlorate P value=0.030, and LysoPE 18.1 P value=0.015) and cholic acid were significantly decreased in the Mastiha group compared to the Placebo. Finally, stratification on BMI allowed the identification of significantly lower levels of cT1 and LIF (P value= 0.033 and 0.049, respectively) in the Mastiha group compared to the Placebo in severe obese patients. Conclusions: Mastiha supplementation improves microbiota dysbiosis and lipid levels in patients with NAFLD, mainly through a prebiotic anti-inflammatory action. Also, it exhibits a favorable effect on MRI parameters in severe obese NAFLD patients.