Scholarlink

Background <p>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.</p> Method <p>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&#xa0;g/day of chitosan (500&#xa0;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.</p> Conclusion <p>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.</p> Trial registration <p>This study is registered on the Iranian Registry of Clinical Trials (IRCT20230522058260N1: <a href="https://www.irct.ir/trial/79063">https://www.irct.ir/trial/79063</a>) and first release date of 8th March 2025.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年2月14日

查看全文
  • Mahsa Rouini,
  • Hadis Alimoradi,
  • Ali Chamani,
  • Fatemeh Sadat Hashemi Javaheri,
  • Mohsen Nematy,
  • Ebrahim Falahi

摘要

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.