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Study aim
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Determination and comparison of the effects of Calbin A supplementation on cardiometabolic indices, liver function tests, ultrasonographic findings, and quality of life in patients with metabolic dysfunction–associated steatotic liver disease (MASLD) before and after the intervention.
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Design
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Clinical trial study with a control group, with two arm parallel-group, double-blind, randomized, phase 3 on 90 patients. For randomization, the block method (blocks of 4) and the site https://sealedenvelope.com/simple-randomiser/v1) will be used.
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Settings and conduct
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This clinical trial will be conducted among patients with MASLD attending a gastroenterology and hepatology subspecialty clinic. Calbin A supplement and placebo will be provided to participants in completely identical packaging for 12 weeks. Both the participants and the investigator will be blinded to the type of intervention.
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Participants/Inclusion and exclusion criteria
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Adult patients aged 18–65 years diagnosed with MASLD (hepatic steatosis plus at least one of the five metabolic dysfunction criteria) and a FIB-4 index > 1.3.
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Intervention groups
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The intervention group will receive two Calbin A capsules daily (each capsule containing 25 mg of Calbin A plus 5 mg of piperine), and the control group will receive two placebo capsules daily (each capsule containing 25 mg of maltodextrin plus 5 mg of piperine) for 12 weeks.
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Main outcome variables
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Before and after the intervention, serum liver enzymes (ALT, AST, ALP, and GGT), inflammatory markers (CRP and IL-6), oxidative stress indices (MDA, TAC, and SOD), and liver functional indices (FLI, FIB-4, and APRI) will be assessed as primary outcomes.
Secondary outcomes will include glycemic indices, lipid profile, hepatic ultrasonographic findings, quality of life score, sleep quality score, depression, anxiety and stress scores, and mean anthropometric indices.