Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07564947

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

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

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

35 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Agriculture, Peshawar

Peshawar, Khyber Pakhtunkhwa, 25120, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Starch Placebo

Dietary Supplement

Intervention will invovle the the intake of Starch Placebo capsule

Ganoderma lucidum

Dietary Supplement

Intervention will involve the intake of Ganoderma lucidum mushroom powder

Primary outcomes

  1. 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.

Secondary outcomes

  1. LFTs

    Time frame: Baseline (day one) - 12 weeks & 24 weeks (endline)

    Liver Function Test inclusing ALT, AST and ALP will be mesuare.

  2. Lipid Profile

    Time frame: Baseline (day one) - 12 weeks & 24 weeks (endline)

    Lipid profile including LDL-C, HDL-C, triglycerides will be estimated.

  3. 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.

  4. TNF-alpha

    Time frame: Basline (day one)- 12 weeks & 24 weeks

    TNF-alpha will measured as marker of inflmmation.

  5. Abdominal Ultrasound

    Time frame: Basline (day one) - 12 weeks & 24 weeks

    Abdominal Ultrasound to asses fat acculumation in liver.

Sponsors and collaborators

Lead sponsor

University of Agriculture, Peshawar

Other

Registry information

Official study title

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

Acronym: GL-MAFLD-NFR2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.