Impact of Ganoderma Lucidum on NRF2 Levels and Antioxidant Status in Metabolic Asscociated Fatty Liver Disease (GL-MAFLD-NRF2 Study) (GL-MAFLD-NFR2)

April 27, 2026 updated by: Kalsoom Siddiq, University of Agriculture, Peshawar

Impatc of Ganoderma Lucidum on NRF2 Levels and Antioxidant Status in Metabolic Asscociated Fatty Liver Disease

This RCT investigates the impact of Ganoderma lucidum on antioxidant staus, NRF2 levels and lipid metabolism in individuals with Metabolic Associated Fatty Liver Disease.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The prevalence of non-alcoholic fatty liver disease (NAFLD) is increasing worldwide. Unfortunately, for the treatment of NAFLD no FDA-approved drugs are available currently. Therefore, natural products are currently used as alternative treatments for fatty liver disease. Ganoderma lucidum is a traditional, medicinal edible mushroom with significant health benefits. It contains bioactive compounds such as polysaccharides, polyphenols and triterpenoids which have significant antioxidant, anti-inflammatory and anti-cancer properties.

Previous studies have shown the protective effect of GL extract against cancer, diabetes and hepatotoxicity. However, limited evidence is available on the specific interaction of these compounds with Nrf2 pathway a key regulator of cellular redox balance and detoxification has not been extensively studied. Therefore, the present study aims to investigate the effect of GL extract on the Nrf2 pathway in human experimental models.

By elucidating the molecular mechanisms involved, this study could pave the way for the development of new, natural, and effective interventions for a variety of chronic diseases driven by oxidative stress and inflammation. Moreover, the findings may contribute to the broader field of nutraceutical and their role in supporting health at the cellular level.

Previous studies in animal models have shown the potential lipid lowering mechanism of GLP. However, few human intervention studies have been conducted on the effect of GL on lipid lowering pathways in humans. Therefore, the present study aims to investigate the effect of GL on lipid lowering mechanisms in human studies.

This study will provide new knowledge on the potential for the mushroom extract on liver, inflammatory and oxidative stress biomarkers that may be of benefit for the prevention and control of non-alcoholic fatty liver.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Khyber Pakhtunkhwa
      • Peshawar, Khyber Pakhtunkhwa, Pakistan, 25120
        • The University of Agriculture, Peshawar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 35-49 years.
  • Stage 1 and 2 fatty liver
  • 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:TNF-α ≥8 pg/mL

Exclusion Criteria:

  • Participants having diabetes, psychological illness or depression, renal or cardiac disease, or other physiological conditions such as pregnancy, breastfeeding, or a history of stroke will excluded from this research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Starch
Starch will be used as placebo comparator.
Dietary supplement: Starch Placebo
Intervention will invovle the the intake of Starch Placebo capsule
Experimental: Intervention
Ganoderma lucidum mushroom powder will be used as experimental capsule.Each capsule contains 1000 mg of mushroom dried powder
Dietary supplement: Ganoderma lucidum
Intervention will involve the intake of Ganoderma lucidum mushroom powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Total Antioxidant Capacity (T-AOC)
Time Frame: Baseline (day one) - 12 week & 24 weeks
Plasma Total Antioxidant Capacity (T-AOC) will be measured to determined the antioxidative effect of ganoderma mushroom in participants with fatty liver.
Baseline (day one) - 12 week & 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LFTs
Time Frame: Baseline (day one) - 12 weeks & 24 weeks (endline)
Liver Function Test inclusing ALT, AST and ALP will be mesuare.
Baseline (day one) - 12 weeks & 24 weeks (endline)
Lipid Profile
Time Frame: Baseline (day one) - 12 weeks & 24 weeks (endline)
Lipid profile including LDL-C, HDL-C, triglycerides will be estimated.
Baseline (day one) - 12 weeks & 24 weeks (endline)
NRF2 Protein levels
Time Frame: Baseline (day one) - 12 weeks & 24 weeks (endline)
NRF2 Protein levels will be meausred as key regulator of cellular redox and detoxification balance.
Baseline (day one) - 12 weeks & 24 weeks (endline)
TNF-alpha
Time Frame: Basline (day one)- 12 weeks & 24 weeks
TNF-alpha will measured as marker of inflmmation.
Basline (day one)- 12 weeks & 24 weeks
Abdominal Ultrasound
Time Frame: Basline (day one) - 12 weeks & 24 weeks
Abdominal Ultrasound to asses fat acculumation in liver.
Basline (day one) - 12 weeks & 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Agriculture, Peshawar

Investigators

  • Study Chair: Bibi Hajira, PhD, Khyber Medical University Peshawar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 28, 2026

Primary Completion (Estimated)

April 20, 2027

Study Completion (Estimated)

April 20, 2027

Study Registration Dates

First Submitted

April 27, 2026

First Submitted That Met QC Criteria

April 27, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNS-ECHSRB/2025-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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