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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
SponsorUniversity of Lahore

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

● 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • reishi mushroom- (Ganoderma lucidum)

    Dietary supplement

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

  • Placebo

    Dietary supplement

    STARCH CAPCULE

  • Reishi mushroom dried powder

    Dietary supplement

    Reishi mushroom dried powder ONCE A DAY

  • Reishi mushroom dried powder

    Dietary supplement

    Reishi mushroom dried powder TWICE A DAY

Treatment groups

102 Participants
are divided into 3 treatment groups
Group A: Conventional Group (To)Placebo comparator 1 intervention
Group B: Experimental Group (T1)Experimental treatment 2 interventions
Group C: Experimental Group (T2)Experimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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