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RecruitingNCT07534241Updated Jul 30, 2026

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

An interventional study of reishi mushroom- (Ganoderma lucidum) and Placebo in Lipid Profile and Liver Biomarkers, sponsored by University of Lahore. Recruiting at 1 site in Pakistan. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by University of Lahore · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Lipid Profile
  • Liver Biomarkers
03

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
102 participants (estimated)

Study arms

  • Placebo comparator
    Conventional Group (To)

    starch capsules

    Dietary Supplement: Placebo

  • Experimental
    Experimental Group (T1)

    Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken alongside a probiotic-rich diet.

    Dietary Supplement: reishi mushroom- (Ganoderma lucidum) · Dietary Supplement: Reishi mushroom dried powder

  • Experimental
    Experimental Group (T2)

    Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken twice alongside a probiotic-rich diet.

    Dietary Supplement: reishi mushroom- (Ganoderma lucidum) · Dietary Supplement: Reishi mushroom dried powder

Interventions

  • Dietary supplementreishi mushroom- (Ganoderma lucidum)

    Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken alongside a probiotic-rich diet.

  • Dietary supplementPlacebo

    STARCH CAPCULE

  • Dietary supplementReishi mushroom dried powder

    Reishi mushroom dried powder ONCE A DAY

  • Dietary supplementReishi mushroom dried powder

    Reishi mushroom dried powder TWICE A DAY

05

What researchers measure

Primary outcomes

  1. LIPID PROFILE

    Fasting blood samples will be collected at baseline and post-intervention to measure serum levels

    Time frame: 12 WEEKS

Secondary outcomes

  1. Liver enzymes

    * Alanine Aminotransferase (ALT): Assessed using validated methods * Aspartate Aminotransferase (AST): Measured according to established protocols * Alkaline Phosphatase (ALP): Activity determined using outlined methods

    Time frame: 12 weeks

06

Study locations

1 of 1 sites recruiting
07

References and documents

Related links

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07534241
Lead sponsor
University of Lahore
Responsible party
Sponsor
First posted
Apr 16, 2026
Start date
Oct 2, 2025
Primary completion
Dec 31, 2025
Completion
Dec 15, 2026 (estimated)
Last update
Jul 30, 2026

Study contacts

Sana Noreen, PhD
Contact
sananoreen.rizwan@gmail.com
03018661160

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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