MAFLDGL-MAFLD-NFR2NCT07564947
Impact of Ganoderma Lucidum on NRF2 Levels and Antioxidant Status in Metabolic Asscociated Fatty Liver Disease (GL-MAFLD-NRF2 Study)
A study testing Ganoderma lucidum in people with MAFLD and Fatty Liver, run by University of Agriculture, Peshawar at 1 site in Pakistan.
Trial summary
This RCT investigates the impact of Ganoderma lucidum on antioxidant staus, NRF2 levels and lipid metabolism in individuals with Metabolic Associated Fatty Liver Disease. Read more about this study
- Who is it for?
- Ages 35 to 49 years
- Conditions the study is for
- MAFLD, Fatty Liver, Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD
- What is being tested?
- Ganoderma lucidum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Apr 2026to 20 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
The University of Agriculture, Peshawar
Peshawar, Khyber Pakhtunkhwa, 25120
About this study
Official title: 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.
Read the 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.
- Conditions
- MAFLD, Fatty Liver, Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD, Fatty Liver, Nonalcoholic, Fatty Liver Disease, Oxidative Stress
- Being tested
- Starch Placebo, Ganoderma lucidum
- Keywords
- MAFLD, Mushroom, Ganoderma Lucidum, NRF2
- Medical subject headings
- Fatty Liver, Non-alcoholic Fatty Liver Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starch PlaceboDietary supplement
Intervention will invovle the the intake of Starch Placebo capsule
Ganoderma lucidumDietary supplement
Intervention will involve the intake of Ganoderma lucidum mushroom powder
| Study group | Role | What they receive |
|---|---|---|
| Starch | Placebo comparator | Starch will be used as placebo comparator. Receives: Dietary Supplement: Starch Placebo |
| Intervention | Experimental | Ganoderma lucidum mushroom powder will be used as experimental capsule.Each capsule contains 1000 mg of mushroom dried powder Receives: Dietary Supplement: Ganoderma lucidum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Total Antioxidant Capacity (T-AOC)
Plasma Total Antioxidant Capacity (T-AOC) will be measured to determined the antioxidative effect of ganoderma mushroom in participants with fatty liver.
Measured: Baseline (day one) - 12 week & 24 weeks
Secondary outcomes (5)
LFTs
Liver Function Test inclusing ALT, AST and ALP will be mesuare.
Measured: Baseline (day one) - 12 weeks & 24 weeks (endline)
Lipid Profile
Lipid profile including LDL-C, HDL-C, triglycerides will be estimated.
Measured: Baseline (day one) - 12 weeks & 24 weeks (endline)
NRF2 Protein levels
NRF2 Protein levels will be meausred as key regulator of cellular redox and detoxification balance.
Measured: Baseline (day one) - 12 weeks & 24 weeks (endline)
TNF-alpha
TNF-alpha will measured as marker of inflmmation.
Measured: Basline (day one)- 12 weeks & 24 weeks
Abdominal Ultrasound
Abdominal Ultrasound to asses fat acculumation in liver.
Measured: Basline (day one) - 12 weeks & 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start28 Apr 2026 (estimated)
- Primary completion20 Apr 2027 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Agriculture, Peshawar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kalsoom Siddiq, University of Agriculture, Peshawar
- Investigators
- Bibi Hajira, PhD, Study chair, Khyber Medical University Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564947
- Sponsor's protocol ID
- FNS-ECHSRB/2025-004
- Acronym
- GL-MAFLD-NFR2
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 26120584Chiu 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.
PubMed 28183232
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impatc of Ganoderma Lucidum on NRF2 Levels and Antioxidant Status in Metabolic Asscociated Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT07564947
- Acronym / sponsor ID
- GL-MAFLD-NFR2 / FNS-ECHSRB/2025-004
- Conditions
- MAFLD, Fatty Liver, Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD, Fatty Liver, Nonalcoholic, Fatty Liver Disease, Oxidative Stress
- Keywords
- MAFLD, Mushroom, Ganoderma Lucidum, NRF2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Agriculture, PeshawarUniversity, hospital or other
- Study start
- 28 Apr 2026 (estimated)
- Primary completion
- 20 Apr 2027 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Starch | Placebo comparator | Dietary Supplement: Starch PlaceboStarch will be used as placebo comparator. |
| Intervention | Experimental | Dietary Supplement: Ganoderma lucidumGanoderma lucidum mushroom powder will be used as experimental capsule.Each capsule contains 1000 mg of mushroom dried powder |
Who may qualify
- Ages
- 35 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Starch PlaceboIntervention will invovle the the intake of Starch Placebo capsule | Dietary supplement | Starch |
| Ganoderma lucidumIntervention will involve the intake of Ganoderma lucidum mushroom powder | Dietary supplement | Intervention |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publication: PubMed 26120584Chambel 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.
- Results publication: PubMed 28183232Chiu 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.
- The dual role of Nrf2 in nonalcoholic fatty liver disease: regulation of antioxidant defenses and hepatic lipid metabolism.Link provided by the sponsor.
- Triterpenoids and polysaccharide peptides-enriched Ganoderma lucidum: a randomized, double-blind placebo-controlled crossover study of its antioxidation and hepatoprotective efficacy in healthy volunteersLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bibi Hajira, PhD study chair
Khyber Medical University Peshawar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ganoderma lucidum in people with MAFLD and Fatty Liver, run by University of Agriculture, Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Total Antioxidant Capacity (T-AOC) (time frame: Baseline (day one) - 12 week & 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07564947, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.