Nutritional Counseling vs. Nutritional Supplements for NASH - a Randomized Prospective, Open Label Pilot Study

Exclusion Criteria

• •Alcohol intake of more than 30 g/d (men) or 20 g/d (women)
• •Treatment with ursodeoxycholic acid (UDCA), Vitamin E or other investigational NASH drugs 3 months prior to randomization
• •Treatment with medications or substances that may induce secondary NASH (e.g., tamoxifen, corticosteroids, amiodarone, methotrexate) or ameliorate NASH (TNF-antagonists)
• •Treatment with phenprocoumon or warfarin
• •Hepatocellular carcinoma or non-hepatic malignancy
• •Decompensated cirrhosis (Child B,C) or a history of decompensation
• •Liver disease unrelated to NASH, including chronic viral hepatitis B/D or C, autoimmune hepatitis, Wilson's disease or clinical manifest iron overload
• •Bariatric surgery within the last 5 years
• •BMI \<18,5 kg/m2 or BMI \>45 kg/m2
• •Liver transplantation
• •Heart failure (New York Heart Association Class II - IV)
• •Myocardial infarction, instable coronary artery disease , coronary artery intervention or stroke in the previous 6 months
• •Instable chronic obstructive pulmonary disease, chronic inflammatory bowel disease or rheumatoid arthritis.
• •Instable renal insufficiency (changes in serum creatinin \> 50% in the last 3 month) or terminal renal insufficiency requiring dialysis
• •Uncontrolled hypertension (blood pressure \> 180/90 despite therapy)
• •Uncontrolled diabetes mellitus defined by hemoglobin A1c \> 9
• •Food allergies requiring strictly dietary adherence
• •Pregnant or nursing women
• •Chronic pancreatitis or history of recurring acute pancreatitis