Nonalcoholic fatty liver disease (NAFLD) or metabolic-associated fatty liver disease (MAFLD) represent the most common liver diseases characterized by a chronic liver disease defined by the presence of lipid accumulation within hepatocytes without excessive alcohol consumption. From the data of the Italian Local Health Units, on the basis of administrative data and the use of resources, a progressively increasing average direct cost per NAFLD emerges up to over € 65,000/year. Therapeutically speaking, at the moment a standardized and fully effective therapy for NAFLD is still missing. In this scenario, it has been demonstrated that sulfurous mineral water as complementary treatment could improve glucose metabolism and oxidative status. It has also been showed in an animal model that the administration of calcium-sulfate-bicarbonate water may exert modulatory activity on the gut-liver axis, resulting in improved inflammation and fibrosis and a reduced number of activated hepatic stellate cells, but also lower liver LPS localization and less activation of TLR4 pathways, suggesting potential beneficial effects on NAFLD. Starting from these previous and recent observations, it may be supposed that a thermal-derived water rich in specific elements could exert beneficial effects on metabolic syndrome and NAFLD/MAFLD. This proposal project aims to develop and study, thanks to the synergy between basic and clinical sciences and industrial research, the effects of pharmaceutical products derived from the thermal waters of "Chianciano Terme", alone or in association with other therapeutic agents, improving health of patients suffering from NAFLD/MAFLD.
The project is expected, in 5 years, to create a pharmaceutical (lyophilized) product at a TRL 7 level, derived from mineral and microelements of "Chianciano Terme" thermal water. The project is structured as a "continuum" between basic/clinical science research and industrial research.