Randomised, controlled, crossover clinical trial protocol of puerarin for the treatment of metabolic-associated fatty liver disease in China

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BACKGROUND: Although a number of preclinical studies have demonstrated the therapeutic potential of puerarin for metabolic-associated fatty liver disease (MAFLD), there is a lack of high-quality clinical evidence. This study aims to evaluate the safety and efficacy of puerarin in patients with MAFLD in a randomised, controlled, crossover trial. METHODS AND ANALYSIS: This study will use the randomised, double-blind, placebo-controlled crossover trial design. We plan to enrol 50 patients diagnosed with MAFLD, and they will be randomly assigned in a 1:1 ratio to receive either puerarin or placebo (maltodextrin) after a 2-week adaptation period. Participants in the two groups will receive the daily intervention of puerarin (180 mg/day) and placebo (180 mg/day) for 12 weeks, respectively. After a 4-week washout period, puerarin-treated and placebo-treated participants will cross over to receive the daily intervention of placebo and puerarin for 12 more weeks. The primary outcome measure will be defined as the changes in liver fat content, which will be assessed using MRI-proton density fat fraction before and after 12 weeks of puerarin or placebo supplement in patients with MAFLD. The secondary outcome measures include liver and kidney function changes, lipid metabolism indicators, blood glucose levels, iron metabolism parameters, blood routine, serum high-sensitivity C-reactive protein and anthropometric measurements. Additionally, alterations in gut microbiota composition and metabolic activity will be evaluated using 16S ribosomal RNA gene sequencing and liquid chromatography-mass spectrometry. ETHICS AND DISSEMINATION: The study protocol has been approved by the ethics committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Approval Number 2024-1625-208-01). The findings will be published in international peer-reviewed journals and presented at relevant academic conferences. TRIAL REGISTRATION NUMBER: The trial has been registered with the Chinese Clinical Trial Registry (ChiCTR2400094017).

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