Evaluation of the effects of Melatonin Supplementation on Hepatic Enzymes, Inflammatory Factors, Lipid profile, blood glucose, Insulin Sensitivity, and Hepatic Steatosis grade in patients with Non-alcoholic fatty liver disease

Objectives: Nonalcoholic Fatty Liver Disease (NAFLD) is a wide range of clinical symptoms of liver damage that can lead to liver failure. The main cause is the accumulation of fat (triglycerides or TG) in the liver, which promotes inflammation, steatosis and fibrosis progression. Melatonin is considered one of the strongest antioxidants in the body that may improve insulin resistance and dyslipidemia.The main objective of this study is evaluation the effect of Melatonin supplement on blood lipids, liver enzymes, inflammation factors and degree of liver fibrosis in patients with nonalcoholic fatty liver. Design: This study is a double blind randomized clinical trial. Blinding will be imposed on subjects and researchers. Setting and conduct: Patients with NAFLD will be divided in two intervention (receiving Metatonin supplement) and placebo groups. The period of intervention is 12 weeks. Blood samples will be taken before and after of supplementation. Participants (including major eligibility criteria): Inclusion criteria will be age more than 18 years and steatosis degree equal or more than 2 and exclusion criteria will be suffering from other liver diseases, cancer and autoimmune diseases. Intervention: One 5 mg Melatonin capsule per day in intervention group and one placebo capsule per day in placebo group for 12 weeks. Main outcome measures: Levels of lipid profiles, fasting blood glucose and liver enzymes.

Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences