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

University of Agriculture, Peshawar

Status

Invitation-only

Conditions

Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD

Fatty Liver

Inflammation

Fatty Liver, Nonalcoholic

Oxidative Stress

MAFLD

Fatty Liver Disease

Treatments

Dietary Supplement: Starch Placebo

Dietary Supplement: Ganoderma lucidum

Study type

Interventional

Funder types

Other

Identifiers

NCT07564947

FNS-ECHSRB/2025-004

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

35 to 49 years old

Volunteers

No Healthy Volunteers

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.