Reishi mushroom plus probiotics for liver health in adults with MAFLD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sana Noreen
  Lahore, Pakistan Recruiting

Study contacts

• Study coordinator: Sana Noreen, PhD
• Email: sananoreen.rizwan@gmail.com
• Phone: 03018661160

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.