DOES BERBERINE IMPACT ANTHROPOMETRIC, HEPATIC, AND METABOLIC PARAMETERS IN PATIENTS WITH METABOLIC DYSFUNCTION-ASSOCIATED FATTY LIVER DISEASE? RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

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Abstract
Globally, the metabolic dysfunction-associated fatty liver disease (MAFLD) holds the position as the most widespread chronic liver condition. Berberine (BBR) shows promise as a natural compound for managing obesity, hepatic steatosis, and metabolic disorders. The study aimed to investigate the effectiveness of BBR in addressing factors linked to MAFLD. This is a randomized, double-blind, and placebo-controlled clinical trial. Seventy individuals with MAFLD were enrolled in this study and randomly assigned in a 1:1 ratio to two groups. BBR (1500 mg/day) or placebo was administrated orally for 12 weeks. Selected anthropometric, hepatic, and metabolic parameters were assessed. After a 12-week intervention, the BBR group demonstrated a statistically significant decrease in alanine transaminase (ALT) p=0.0105, and de Ritis ratio p=0.0011 compared to the control group. In both groups we observed a decrease in trunk fat (kg) - BBR group p=0.0185, and placebo group p=0.0323. After three months, a significant divergence between the BBR and placebo groups was evident in the alteration of D total cholesterol (TC) p=0.0009, favoring the BBR group. Nevertheless, there were no significant differences detected in other lipid and glucose parameters. In the BBR group, we found significant correlations between changes and amelioration of certain variables: D body mass index (BMI) correlated with DALT (r=0.47; p=0.0089) and D aspartate aminotransferase (AST) (r=0.47; p=0.0081) levels; D trunk fat with D fatty liver index (FLI) (r=0.55; p=0.0337), D homeostasis model assessment for insulin resistant index (HOMAIR) (r=0.37; p=0.0020), and AST (r=0.42; p=0.0202); D the de Ritis ratio correlated with D fibrosis-4 index (FIB-4) levels (r=0.59; p=0.0011); and DFLI correlated with DHOMA-IR (r=0.37; p=0.0409) and D visceral adiposity index (VAI) (r=0.54; p=0.0019), while no significant differences were observed in the Placebo group. The results show that BBR appears to be a bioactive compound that positively impacts MAFLD, however, additional research with extended intervention durations is required to fully assess its efficacy and potential clinical use.

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