Study to Evaluate the Effectiveness of Legalon®

Inclusion Criteria:

1. 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.

2. Male/female, 18 years of age and older

3. Able to provide informed consent

4. Available baseline blood results not older than 4 weeks from inclusion, withelevated plasma level of at least one liver enzyme with respect to normal ranges oflocal laboratory (>1 UNL)

5. NAFLD diagnosed by ultrasonography according to the protocol by Hamaguchi or by theprotocol of Ballestri

6. Presence of metabolic syndrome, defined as the presence of at least 3 out of 5 ofthe following:

7. Central obesity (for Asian population, waist circumference ≥90 cm in males, ≥80cm in females)

8. Insulin resistance (fasting blood glucose ≥100mg/dl or under medication)

9. High blood pressure (≥ 130/85 mmHg or on medication)

10. High triglycerides (≥150 mg/dl or on medication)

11. Low HDL-cholesterol (<40mg/dl in men, <50mg/dl in women)

12. Started diet and exercise interventions, as per treating Investigator's suggestionand in line with current guidelines within a 4-week window prior to enrolment intothe study

Exclusion Criteria:

1. Significant alcohol intake >7 standard alcoholic drinks per week (70 g ethanol) inwomen and >14 (140 g) in men

2. Received Legalon® or any other hepatoprotective treatment before the allowed 4-weekwindow prior to enrolment into the study.

3. On diet and exercise before the allowed 4-week window prior to enrolment into thestudy.

4. Other concomitant established / diagnosed liver diseases, including chronichepatitis B, chronic hepatitis C, autoimmune liver diseases (including autoimmunehepatitis), celiac disease, primary biliary cholangitis, primary sclerosingcholangitis, biliary obstruction, drug-induced liver disease (including herbalmedicines and dietary supplements), metabolic liver disorders (such as Wilson'sdisease, alpha-1- antitrypsin deficiency, hemochromatosis, glycogen storagedisorders, cholesterol storage disorders), severe liver diseases, non-alcoholicsteatohepatitis (NASH) or other forms of advanced fatty liver disease (includingclinically relevant fibrosis, >F2, or established cirrhosis), liver carcinoma

5. Patients treated with drugs with known hepatotoxic effects (at risk of drug-inducedliver injury [DILI]), including herbal medicines and dietary supplements

6. Other major diseases that, in the treating Investigator opinion, can impair liverfunction, as for example type 1 diabetes

7. Pregnant and/or breastfeeding women

8. Persons that, in treating Investigator's opinion, are not able to fulfil studyrequirements

9. Persons that refuses to participate

10. Patients that, in the Investigator's opinion, are or have been infected withCOVID-19 (i.e. presence/referral of COVID-19 symptoms or positiveantigenic/molecular test)