Effect of LIVOGEN, a nutraceutical containing natural bioactive components bergamot extract, artichoke leaf extract, Nigella sativa, EPA, DHA and silybin, on individuals affected by liver steatosis (fatty liver disease)

INTERVENTION: Participants will be enrolled after a written informed consent will be obtained and will be randomly assigned (by computer‐generated random numbers) in a 1:1 ratio to receive either the nutraceutical or a placebo for up to 12 weeks The nutraceutical and placebo softgel capsules will be supplied by the Thishcon corp. The capsules will be similar in shape, size, and color. The Livogen Plus® study dose are the follow: 6 softgels daily, 3 with each main meal (lunch and dinner). The same for placebo. The enrollment period will be of at least 18 months. We will assess the CAP score by Elastography ( Fibroscan). The treatment period will last 3 months. CONDITION: Liver steatosis ; Digestive System ; Nonalcoholic fatty liver disease [NAFLD] PRIMARY OUTCOME: ; 1. CAP score value will be measured by Fibroscan at baseline and after 12 weeks of treatment; 2. Serum lipid (cholesterol, HDL‐cholesterol, and triglycerides) profile will be assessed by chemiluminescent immunoassay at baseline and after 12 weeks of treatment; 3. AST, ALT, and GGT will be measured by chemiluminescent immunoassay at baseline and after 12 weeks of treatment; Insulin will be determined by chemiluminescent immunoassay at baseline and after 12 weeks of treatment; 4. C‐reactive protein (CRP) will be measured by chemiluminescent immunoassay at baseline and after 12 weeks of treatment.; 5. Serum interleukin‐1ß (IL‐1ß), interleukin‐6 (IL‐6), and tumor necrosis factor a (TNF‐a) will be determined by sandwich enzyme‐linked immunosorbent assay (ELISA) at baseline and after 12 weeks of treatment at baseline and after 12 weeks of treatment.; SECONDARY OUTCOME: There are no secondary outcome measures INCLUSION CRITERIA: 1. NAFLD defined by a CAP score value =247 dB/m 2. Age 30 ‐ 75 years