Effect of Total Anthocyanin-base Standardized Cornus Mas L. Fruit Extract on Hepatic Steatosis and Visceral Adiposity Index in Patients With Non-alcoholic Fatty Liver Disease: a Double-blind Randomized Controlled Trial

Background: Nonalcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide. Experimental evidence has proposed the beneficial effects of Cornus mas L. (cornelian cherry) extract, as a rich source of anthocyanins, on steatosis and central obesity. However, very few clinical trials were conducted in this regard. We investigated the effect of total anthocyanin-base standardized cornelian cherry fruit extract on hepatic steatosis index (HSI) and NAFLD liver fat score (NAFLD-LFS), and visceral adiposity index (VAI) in patients with NAFLD. Methods: The present study was conducted as a double-blind, randomized controlled clinical trial among 50 subjects suffering from NAFLD. Subjects were randomly assigned to receive cornelian cherry extract (20 cc/d, which provides 320 mg/d total anthocyanin) or placebo for 12 weeks. Results: There was no difference between the two groups in HSI, NAFLD-LFS and VAI at the baseline. After 12-week intervention, cornelian cherry extract compared to the placebo demonstrated no significant effect on HSI (change: -0.9 ± 3.5 vs. -1.2 ± 3.2; P = 0.72), NAFLD-LFS (change: 0.2 ± 1.3 vs. 0.1 ± 0.7; P = 0.62), and VAI (change: 0.05 ± 0.7 vs. 0.07 ± 1.0; P = 0.94). Conclusion: Cornelian cherry extract (20 cc/d) for 12 weeks has no effect on steatosis and visceral obesity. To better conclude, further trials with longer intervention durations are required. Trial registration: The study protocol was registered on 30 September 2018 at Iranian Registry of Clinical Trials under code IRCT20180419039359N1 (https://www.irct.ir/trial/30707).