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
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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