The effect of melatonin on treatment of patients with non-alcoholic fatty liver disease: a randomized double blind clinical trial

Abstract

Objectives: Many factors implicated in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) are including oxidative stress, insulin resistance and abnormal production of adipokines. The aim of this clinical trial was to evaluate the effect of melatonin supplement on some important biochemical markers and signs related to NAFLD.

Design: A randomized double-blind, placebo-controlled, clinical trial.

Setting: Twenty-four participants in the melatonin group and 21 participants in the placebo group completed the study.

Intervention: Participants received 6 mg melatonin or placebo daily, 1 h before bedtime. The intervention period was 12 weeks.

Main outcome measures: Anthropometric measurements, systolic and diastolic blood pressure, liver enzymes, high sensitive C‑reactive protein (hs-CRP), fatty liver grade, also leptin and adiponectin serum levels, were measured at the baseline and the end of intervention.

Results: A significant improvement was observed in weight (p = 0.043), waist circumference (p = 0.027), abdominal circumference (p = 0.043), systolic (p = 0.039), and diastolic (p = 0.015) blood pressure, leptin serum levels (p = 0.032), hs-CRP (p = 0.024), alanine aminotransferase (p = 0.011), aspartate aminotransferase (p = 0.034), also the grade of fatty liver (p = 0.020) in melatonin treated group compared with the placebo.

Conclusions: Administration of 6 mg/day melatonin had improvement effect on many factors related to NAFLD such as liver enzymes, hs-CRP, anthropometric measurements, blood pressure, leptin serum levels and the grade of fatty liver.

Keywords: adiponectin; anthropometry; inflammation mediators; leptin; melatonin; non-alcoholic fatty liver disease.