NCT07534241

Hepatoprotective Effects of Reishi Mushroom- (Ganoderma Lucidum) Among Metabolic Dysfunction-associated Fatty Liver Disease Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: University of Lahore · Academic / Other
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This 12-week RCT investigates the hepatoprotective and immunomodulatory effects of Ganoderma lucidum combined with a probiotic-rich diet in adults with MAFLD, assessing liver enzymes, lipid profile, inflammation, gut microbiota, and oxidative stress. Findings are expected to show dose-dependent improvements in hepatic fat, insulin resistance, and inflammatory markers, potentially reducing reliance on pharmacotherapy in

Detailed description

This study evaluates the therapeutic potential of (Ganoderma lucidum), combined with a probiotic-rich diet, to impose immunomodulatory and hepatoprotective effects in adults (35-65 years old) diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD). A 12-week randomized controlled trial (RCT) will be conducted, enrolling participants into three arms: a control group (starch capsules) and two intervention groups receiving either 250 mg or 500 mg of standardized Reishi extract daily. Primary outcomes include improvements in liver function markers (ALT, AST, ALP), lipid metabolism (LDL-C, HDL-C, triglycerides), and inflammatory biomarkers (CRP, IL-6). Secondary outcomes will assess gut microbiota composition (via 16S rRNA sequencing) and oxidative stress markers). Preliminary evidence suggests the Reishi-probiotic combination may significantly reduce hepatic fat accumulation (p\<0.05) and serum LPS levels while increasing beneficial gut bacteria (e.g., Bifidobacterium spp.). We anticipate dose-dependent improvements in HOMA-IR scores and NF-κB suppression, correlating with triterpenoid bioavailability. If validated, this intervention could reduce reliance on pharmacotherapies by 30-40% in early-stage MAFLD, with synergistic effects observed between Beta-glucans and probiotic strains.

Conditions

• Lipid Profile
• Liver Biomarkers

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	reishi mushroom- (Ganoderma lucidum)	Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken alongside a probiotic-rich diet.
DIETARY_SUPPLEMENT	Placebo	STARCH CAPCULE
DIETARY_SUPPLEMENT	Reishi mushroom dried powder	Reishi mushroom dried powder ONCE A DAY
DIETARY_SUPPLEMENT	Reishi mushroom dried powder	Reishi mushroom dried powder TWICE A DAY

Timeline

• Start date: 2025-10-02
• Primary completion: 2026-02-01
• Completion: 2026-04-15
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: Pakistan