Study to Evaluate the Effectiveness of Legalon®

Prior treatment

• Received Legalon® or any other hepatoprotective treatment before the allowed 4-week window prior to enrolment into the study.
• On diet and exercise before the allowed 4-week window prior to enrolment into the study.
• Other concomitant established / diagnosed liver diseases, including chronic hepatitis B, chronic hepatitis C, autoimmune liver diseases (including autoimmune hepatitis), celiac disease, primary biliary cholangitis, primary sclerosing cholangitis, biliary obstruction, drug-induced liver disease (including herbal medicines and dietary supplements), metabolic liver disorders (such as Wilson's disease, alpha-1- antitrypsin deficiency, hemochromatosis, glycogen storage disorders, cholesterol storage disorders), severe liver diseases, non-alcoholic steatohepatitis (NASH) or other forms of advanced fatty liver disease (including clinically relevant fibrosis, \>F2, or established cirrhosis), liver carcinoma
• Patients treated with drugs with known hepatotoxic effects (at risk of drug-induced liver injury \[DILI\]), including herbal medicines and dietary supplements

Other illness

• Other major diseases that, in the treating Investigator opinion, can impair liver function, as for example type 1 diabetes
• Patients that, in the Investigator's opinion, are or have been infected with COVID-19 (i.e. presence/referral of COVID-19 symptoms or positive antigenic/molecular test)

Other

• Significant alcohol intake \>7 standard alcoholic drinks per week (70 g ethanol) in women and \>14 (140 g) in men
• Pregnant and/or breastfeeding women
• Persons that, in treating Investigator's opinion, are not able to fulfil study requirements
• Persons that refuses to participate

• Legalon® monotherapy prescribed by the treating Investigator according to the SPC, independently from and within a 4-week window prior to enrolment into the study.
• Male/female, 18 years of age and older
• Able to provide informed consent
• Available baseline blood results not older than 4 weeks from inclusion, with elevated plasma level of at least one liver enzyme with respect to normal ranges of local laboratory (\>1 UNL)
• NAFLD diagnosed by ultrasonography according to the protocol by Hamaguchi or by the protocol of Ballestri
• Presence of metabolic syndrome, defined as the presence of at least 3 out of 5 of the following:
  • Central obesity (for Asian population, waist circumference ≥90 cm in males, ≥80 cm in females)
  • Insulin resistance (fasting blood glucose ≥100mg/dl or under medication)
  • High blood pressure (≥ 130/85 mmHg or on medication)
  • High triglycerides (≥150 mg/dl or on medication)
  • Low HDL-cholesterol (\<40mg/dl in men, \<50mg/dl in women)
• Started diet and exercise interventions, as per treating Investigator's suggestion and in line with current guidelines within a 4-week window prior to enrolment into the study