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Background: Non-alcoholic fatty liver disease is the most common cause of liver-related morbidity and mortality in the world. However, no effective pharmacological treatment for this condition has been found. Purpose: This study evaluated the effect of a nutraceutical containing bioactive components from Bergamot citrus and wild cardoon as a treatment for individuals with fatty liver disease. The primary outcome measure was the change in liver fat content. Methods: A total of 102 patients with liver steatosis were enrolled in a double-blind placebo controlled clinical trial. The intervention group received a nutraceutical containing a Bergamot polyphenol fraction and Cynara Cardunculus extract, 300 mg/day for 12 weeks. The control group received a placebo daily. Liver fat content, by transient elastography, serum transaminases, lipids and glucose were measured at the baseline and the end of the study. Results: We found a greater liver fat content reduction in the participants taking the nutraceutical rather than placebo (-48.2 ± 39 vs. -26.9 ± 43 dB/m, p = 0.02); The percentage CAP score reduction was statistically significant in those with android obesity, overweight/obesity as well as in women. However, after adjustment for weight change, the percentage CAP score reduction was statistically significant only in those over 50 years (44 vs. 78% in placebo and nutraceutical, respectively, p = 0.007). Conclusions: This specific nutraceutical containing bioactive components from Bergamot and wild cardoon reduced the liver fat content during 12 weeks in individuals with liver steatosis over 50 years. If confirmed, this nutraceutical could become the cornerstone treatment of patients affected by liver steatosis. Clinical Trial Registration: www.isrctn.com, identifier ISRCTN12833814., (Copyright © 2020 Ferro, Montalcini, Mazza, Foti, Angotti, Gliozzi, Nucera, Paone, Bombardelli, Aversa, Musolino, Mollace and Pujia.)

In previous findings the lipidic fractions extracted acc. to Folch from the mature muds of the majority of the Italian thermal springs hot baths was studied, with the aim to identify the organic substrates of their therapeutical activity. The organic components of the "mature" peloids are produced by the metabolism of the microphytozooplankton growing spontaneously in the clay-substrate, in contact with the hot water. The Popes thermal springs (Bagnaccio's Lake) are characterised by an unique environmental situation, because the muds are naturally matured in the hot thermal water, but not in artificial baths. The morphohistochemical aspects of thermal algae growing in the Bagnaccio's lake have been studied by means of Computerised Optic Probe Video-Microscopy, using a not contact zoom objective 70-400x. Peloid types, both the "white" and the "black" contains yellow pigments, fragments of hyphae, monocellular algae, Diatomeae, Cyanophyceae and few other species. The biochemical aspects of the muds extracts are characterised by the presence of Phospholipids (PC, PE, PS, SP), a series of Hydrocarbons ranging from C30 to C38, Phytosterols (beta-sitosterol, Campesterol, Stigmasterol and traces of Cholesterol), Free Fatty Acids (Palmitic, Palmitoleic, Myristic, Stearic, Oleic and Linoleic, heptadecenoic and heptadecanoic) and Terpenes (beta-amirrhyne, 24-methylene-cyclo-arthanole). In our opinion, the therapeutic effects of the mature muds are related to its organic components, with special regards to Phospholipids, Phytosterols and Terpenes. The richness of these components in the Popes Thermal springs seems to be great interest in the dermatological and cosmetic applications, other then the traditional use.