evaluation of the effectiveness of ellagic acid on liver steatosis in overweight/obese non-alcoholic fatty liver disease patients: study protocol for a randomized controlled trial

Introduction: non-alcoholic fatty liver (nafld) is a condition that can lead to liver fibrosis, cirrhosis, and hepatocellular carcinoma. there is no definite treatment for nafld. ellagic acid (ea) is natural polyphenol with proven pharmacological properties, but its effectiveness on nafld in patients is not clear. the aim of this study is to evaluate the effect of ellagic acid on liver fibrosis in nafld patients. method: this randomized, double-blind, controlled, and parallel clinical trial will be conducted on 60 patients with nafld (grade 2 or above) who will be allocated in intervention or placebo groups with 1:1 ratio. the intervention group will receive capsules containing 200 mg ea while the placebo group will receive avicel as placebo for 8 weeks. body composition and anthropometric indices will be measured at baseline, end of 4th and 8th week. transient elastography, 3-day food record, international physical activity questionnaire (ipaq), and laboratory tests (cbc/diff, uric acid, creatinine, lipid profile (total cholesterol, triglyceride [tg], low-density lipoprotein cholesterol [ldl-c], and high-density lipoprotein cholesterol [hdl-c]), aspartate aminotransferase [ast], alanine aminotransferase [alt], alkaline phosphatase [alp], and gamma-glutamyl transpeptidase [ggt], albumin, high sensitive c-reactive protein [hs-crp] and insulin) will be performed for both groups at baseline and end of the study. conclusion: we expect that 200 mg ea ellagic acid administration for 8 weeks will improve liver steatosis, clinical and paraclinical outcomes in nafld patients.