Impact of Ganoderma Lucidum on NRF2 Levels and Antioxidant Status in Metabolic Asscociated Fatty Liver Disease (GL-MAFLD-NRF2 Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Starch Placebo, Ganoderma lucidum.
- Who it may be relevant to
- Registry conditions: MAFLD, Fatty Liver, Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD, Fatty Liver, Nonalcoholic. Basic parameters: 35 years — 49 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impatc of Ganoderma Lucidum on NRF2 Levels and Antioxidant Status in Metabolic Asscociated Fatty Liver Disease
Overview
This RCT investigates the impact of Ganoderma lucidum on antioxidant staus, NRF2 levels and lipid metabolism in individuals with Metabolic Associated Fatty Liver Disease.
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.
Interventions
- Dietary supplement Starch Placebo
Intervention will invovle the the intake of Starch Placebo capsule - Dietary supplement Ganoderma lucidum
Intervention will involve the intake of Ganoderma lucidum mushroom powder
Primary outcome measures
- Plasma Total Antioxidant Capacity (T-AOC) [Time frame: Baseline (day one) - 12 week & 24 weeks]
Secondary outcome measures (5)
- LFTs [Time frame: Baseline (day one) - 12 weeks & 24 weeks (endline)]
- Lipid Profile [Time frame: Baseline (day one) - 12 weeks & 24 weeks (endline)]
- NRF2 Protein levels [Time frame: Baseline (day one) - 12 weeks & 24 weeks (endline)]
- TNF-alpha [Time frame: Basline (day one)- 12 weeks & 24 weeks]
- Abdominal Ultrasound [Time frame: Basline (day one) - 12 weeks & 24 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Pakistan · 1 center
- The University of Agriculture, Peshawar — Peshawar
Publications
- Chambel SS, Santos-Goncalves A, Duarte TL. The Dual Role of Nrf2 in Nonalcoholic Fatty Liver Disease: Regulation of Antioxidant Defenses and Hepatic Lipid Metabolism. Biomed Res Int. 2015;2015:597134. doi: 10.1155/2015/597134. Epub 2015 May 18. PMID 26120584
- Chiu HF, Fu HY, Lu YY, Han YC, Shen YC, Venkatakrishnan K, Golovinskaia O, Wang CK. Triterpenoids and polysaccharide peptides-enriched Ganoderma lucidum: a randomized, double-blind placebo-controlled crossover study of its antioxidation and hepatoprotective efficacy in healthy volunteers. Pharm Biol. 2017 Dec;55(1):1041-1046. doi: 10.1080/13880209.2017.1288750. PMID 28183232
Identifiers
NCT: NCT07564947 · FNS-ECHSRB/2025-004