Does naringenin supplementation improve lipid profile, severity of hepatic steatosis and probability of liver fibrosis in overweight/obese patients with NAFLD? A randomised, double-blind, placebo-controlled, clinical trial.

BACKGROUND AND OBJECTIVES Naringenin has been reported to have some promising pharmacological effects on the management of obesity and related metabolic complications including non-alcoholic fatty liver disease (NAFLD). Therefore, the present clinical trial study was done to assess the effects of naringenin supplementation on lipid profile, aminotransferase levels, severity of steatosis, as well as probability of fibrosis in overweight/obese patients with NAFLD. MATERIALS AND METHODS This placebo-controlled, parallel randomised, double-blind clinical trial study was conducted on 44 eligible overweight/obese patients with NAFLD (naringenin-treated group (n = 22), control group (n = 22)) referred to the national Iranian oil company (NIOC) Central Hospital, Tehran City, Tehran Province, Iran. Participants were randomly assigned to receive naringenin capsules (100 mg) and identical placebo capsules twice a day, before lunch and dinner, for 4 weeks. The primary outcomes were improvement of liver steatosis and NAFLD fibrosis score (NFS), and secondary outcomes included changes in levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and lipid profile. RESULTS Naringenin consumption significantly reduced percentages of NAFLD grades (P < .001), as well as, serum levels of triglyceride (TG) (P < .001), total cholesterol (TC) (P = .01), and low-density lipoprotein (LDL) (P = .02) and increased serum level of high-density lipoprotein (HDL) (P = .02) compared with the control group. Even after adjusting for the confounders, the results were significant. However, there were no significant changes in AST, ALT and NFS. CONCLUSION Our findings revealed that daily intake of 200 mg of naringenin for 4 weeks had beneficial effects on lipid profile and percentages of NAFLD grades as an indicator for the severity of hepatic steatosis. Although, NFS values and serum levels of aminotransferase enzymes including AST and ALT did not remarkably change.