Reishi mushroom plus probiotics for liver health in adults with MAFLD

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

This 12-week trial will test whether daily Reishi (Ganoderma lucidum) extract combined with a probiotic-rich diet can improve liver enzymes, blood lipids, inflammation, and gut microbiota in adults with MAFLD aged 35–65.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 35 Years to 65 Years
• Sex: All
• Sponsor: University of Lahore (Academic / other)
• Locations: 1 site (Lahore)
• Trial ID: NCT07534241 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial enrolls adults 35–65 years with metabolic dysfunction-associated fatty liver disease and elevated liver enzymes into three arms (placebo, 250 mg Reishi extract, and 500 mg Reishi extract) for 12 weeks. Primary outcomes are changes in liver function tests (ALT, AST, ALP), lipid profile (LDL-C, HDL-C, triglycerides), and inflammatory markers (CRP, IL-6), while secondary outcomes include gut microbiota composition by 16S rRNA sequencing and oxidative stress and insulin-resistance measures. The intervention is combined with a probiotic-rich dietary approach and uses dose comparison to explore dose-dependent effects. The trial is led by the University of Lahore with in-person visits at the study site in Lahore, Pakistan.

Who should consider this trial

Good fit: Ideal candidates are adults aged 35–65 with MAFLD, BMI 18.5–30 kg/m², elevated liver enzymes and inflammatory markers, not currently taking lipid-lowering medications, not pregnant or lactating, and without severe cardiac, renal, or other exclusionary conditions.

Not a fit: Patients with advanced liver failure or decompensated disease, those on statins or other lipid-lowering drugs, individuals allergic to mushrooms, pregnant or lactating women, and people with celiac disease are unlikely to benefit or are excluded from participation.

Why it matters

Potential benefit: If successful, the intervention could reduce hepatic inflammation and fat accumulation while improving lipids and insulin resistance, potentially lowering reliance on pharmacologic therapies for early-stage MAFLD.

How similar studies have performed: Preclinical studies and small human trials of Ganoderma and probiotic interventions have shown some hepatoprotective and microbiome benefits, but robust large-scale RCT evidence remains limited.

Eligibility criteria

Inclusion Criteria:

* Adults aged 35-65 years
* BMI between 18.5 and 30 kg/m².
* Complete Blood Count test ranges, WBC \< 4,000-11,000 cells/µL, RBC Men \< 4.5-6.0 / Women 4.0-5.5 million/µL, Hemoglobin: Men \< 13.5-17.5 / Women 12.0-15.5 g/dL, Platelets \< 150,000-450,000 cells/µL.
* Lipid profile test markers (elevated LDL, total cholesterol, or triglycerides less than 150mg/dL high 200-499mg/dL and 500 mg/dL are above high.
* Liver function test markers, ALT \> 56 U/L, AST\>40 U/L, ALP\>147 UL.
* Inflammatory markers: CRP \>3 mg/L, - IL-6 ≥3 pg/mL, TNF-α ≥8 pg/mL.
* Elevated blood sugar levels, or hyperglycemia, refer to a typically above 126 mg/dL, fasting or 200 mg/dL post-meal.

Exclusion Criteria:

* ● Diagnosed with severe cardiovascular disease, liver failure, or renal impairment.

  * Pregnant or lactating women.
  * Individuals currently on statins, ezetimibe, PCSK9 inhibitors, or any other lipid-lowering therapy.
  * Allergic to mushrooms.
  * Diagnosed with celiac disease or other chronic gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis).
  * History of malignancy.
  * Participation in another clinical trial within the last 3 months.

Where this trial is running

Lahore

• Sana Noreen — Lahore, Pakistan (Recruiting)

Study contacts

• Study coordinator: Sana Noreen, PhD

Conditions Lipid Profile; Liver Biomarkers