Efficacy of the nano curcumin supplementation on fibrosis, steatosis, inflammatory and metabolic status of liver fibrosis patients with non-alcoholic fatty liver origin: a study protocol for a double-blind randomized controlled trial.

BACKGROUND: Liver disease related to alcohol consumption and non-alcoholic fatty liver disease (NAFLD) are among the leading causes of liver fibrosis. Curcumin, due to its anti-fibrotic and anti-inflammatory effects, has been proposed as a potential therapeutic agent. However, its clinical application is limited by poor stability, solubility, and bioavailability. Nanocurcumin, a nano-formulated version of curcumin, overcomes these limitations. This study aims to evaluate the efficacy of Nanocurcumin supplementation in improving fibrosis, steatosis, inflammation, and metabolic status in patients with liver fibrosis of NAFLD origin. METHODS: This double-blind, randomized, placebo-controlled trial is being conducted at the Gastroenterology Clinic of Shariati Hospital (Tehran, Iran). Fifty patients aged 30 to 70 years are enrolled and randomly assigned to the intervention or placebo group using a block balanced randomization method. The intervention group receives one capsule of Nanocurcumin (40 mg, twice daily), while the placebo group receives an identical placebo capsule. The primary outcomes include liver fibrosis and steatosis, assessed via FibroScan at baseline and at the end of the study. Secondary outcomes include changes in inflammatory markers, metabolic parameters, liver function tests, anthropometric measures, and blood pressure over the 16-week intervention period. DISCUSSION: This trial is currently ongoing. Recruitment is expected to be completed by the end of 2024, and the trial is anticipated to be fully completed by mid-2025. If Nanocurcumin supplementation demonstrates positive efficacy, it may serve as a potential therapeutic approach for patients with liver fibrosis. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20210427051098N2 (Available from: https://irct.behdasht.gov.ir). Date and version identifier: April 20, 2023; approved version by the IRCT.