Abstract
Hepatic fibrosis, resulting from chronic liver injury, can lead to cirrhosis and liver failure. Curcumin shows anti-fibrotic potential but has low bioavailability. This 16-week double-blind, randomized, placebo-controlled trial evaluated the effects of 80 mg/day nano-curcumin on liver fibrosis, steatosis, liver function test, and anthropometric parameters in 55 adults (30-70 years) with stage ≥ F2 NAFLD-induced fibrosis. Primary outcomes were liver fibrosis and steatosis assessed by FibroScan and FIB-4. Secondary outcomes included changes in liver function tests and anthropometric parameters including body composition. Both groups improved in fibrosis and steatosis, with no significant differences were found between them. The FIB-4 index decreased significantly in the nano-curcumin group (p = 0.022), but between-group differences were not significant (p = 0.135). ALT and AST significantly decreased in the nano-curcumin group (p < 0.001 and p = 0.004), with significant group differences (p < 0.05). GGT reduction was significant between groups after adjustment (p = 0.043), and LDH levels also decreased significantly in the nano-curcumin group (p < 0.001), with a significant between-group difference (p = 0.016). No statistically significant between-group differences were observed in anthropometric parameters. Nano-curcumin improved liver enzymes but showed no significant effect on fibrosis or steatosis compared to placebo. Further research is needed to confirm long-term benefits. Trial registration Iranian Registry of Clinical Trials IRCT20210427051098N2 (Available from: https://irct.behdasht.gov.ir ).