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. 2026 Feb 14;27(1):256.
doi: 10.1186/s13063-026-09504-x.

Effects of chitosan supplementation versus placebo on liver fat and metabolic parameters in patients with non-alcoholic fatty liver disease: a randomized controlled trial protocol

Mahsa Rouini  1 , Hadis Alimoradi  2 , Ali Chamani  3 , Fatemeh Sadat Hashemi Javaheri  4   5 , Mohsen Nematy  4 , Ebrahim Falahi  6
Affiliations

Effects of chitosan supplementation versus placebo on liver fat and metabolic parameters in patients with non-alcoholic fatty liver disease: a randomized controlled trial protocol

Mahsa Rouini et al. Trials. .

Abstract

Background: Nonalcoholic fatty liver disease (NAFLD) is a common chronic liver disorder affecting about one-third of the global population. It encompasses a spectrum from simple steatosis to nonalcoholic steatohepatitis (NASH) and may progress to fibrosis and cirrhosis. Chitosan oligosaccharide (COS) has recently emerged as a potential therapeutic agent with antioxidant and anti-inflammatory properties; however, most evidence comes from animal studies. Further clinical research is therefore warranted to evaluate its efficacy in humans.

Method: This double-blind, randomized, placebo-controlled phase II clinical trial will evaluate the effects of chitosan supplementation in patients with hepatic steatosis. Sixty eligible adults diagnosed by elastography will be recruited from the gastroenterology and liver clinic at Imam Reza Hospital, Mashhad, Iran. Participants will be randomly assigned to receive either 1.5 g/day of chitosan (500 mg capsules, taken three times daily after meals) or a matching placebo for eight weeks. All participants will receive standardized dietary counseling. Primary outcomes include changes in liver fat content measured by elastography at baseline and week 8. Secondary outcomes include alterations in anthropometric measures, liver enzymes, fasting glucose, lipid profile, and insulin resistance.

Conclusion: Based on animal evidence, chitosan supplementation is expected to reduce hepatic fat accumulation, improve liver enzyme levels, and enhance metabolic parameters in patients with NAFLD. If confirmed, these findings could support the potential of chitosan as a promising adjunct for managing hepatic steatosis.

Trial registration: This study is registered on the Iranian Registry of Clinical Trials (IRCT20230522058260N1: https://www.irct.ir/trial/79063 ) and first release date of 8th March 2025.

Keywords: Chitosan; Fatty liver disease; Hepatic steatosis; NAFLD.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study protocol is approved by the Ethics Committee on Lorestan University of Medical Sciences (IR.LUMS.REC.1403.341, 26-November-2024). All significant protocol modifications must be approved by the Ethics Committee on Biomedical Research and communicated to relevant parties. The Ethics Committee on Biomedical Research at Lorestan University of Medical Sciences will perform audits every 12 months, during which the study progress reports will be reviewed and recommendations for the next research plans will be provided. Guardians provide written, informed consent for their children to participate. Consent for publication: Written informed consent will be obtained by trained research staff under the supervision of the principal investigator prior to any study procedures. No ancillary studies involving additional data or biological specimen collection are planned. Therefore, no additional consent beyond the main informed consent is required. Competing interests: The authors have no conflict of interest.

Figures

Fig. 1
Fig. 1
Participant flow diagram according to the Consolidated Standards of Reporting Trials (CONSORT)
Fig. 2
Fig. 2
Trial procedure flow chart
Fig. 3
Fig. 3
Template of the schedule of enrollment, interventions, and assessments
See this image and copyright information in PMC

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