Lipid ProfileNCT07534241
Hepatoprotective Effects of Reishi Mushroom- (Ganoderma Lucidum) Among Metabolic Dysfunction-associated Fatty Liver Disease Patients
A study testing reishi mushroom- (Ganoderma lucidum) and Reishi mushroom dried powder in people with Lipid Profile and Liver Biomarkers, run by University of Lahore at 1 site in Pakistan.
Trial summary
This 12-week RCT investigates the hepatoprotective and immunomodulatory effects of Ganoderma lucidum combined with a probiotic-rich diet in adults with MAFLD, assessing liver enzymes, lipid profile, inflammation, gut microbiota, and oxidative stress. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipid Profile, Liver Biomarkers
- What is being tested?
- reishi mushroom- (Ganoderma lucidum) and Reishi mushroom dried powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Oct 2025to 15 Dec 2026
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 35-65 years
- BMI between 18.5 and 30 kg/m².
- Complete Blood Count test ranges, WBC < 4,000-11,000 cells/µL, RBC Men < 4.5-6.0 / Women 4.0-5.5 million/µL, Hemoglobin: Men < 13.5-17.5 / Women 12.0-15.5 g/dL, Platelets < 150,000-450,000 cells/µL.
- 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: CRP >3 mg/L, - IL-6 ≥3 pg/mL, TNF-α ≥8 pg/mL.
- Elevated blood sugar levels, or hyperglycemia, refer to a typically above 126 mg/dL, fasting or 200 mg/dL post-meal.
Who cannot join
- ● Diagnosed with severe cardiovascular disease, liver failure, or renal impairment.
- Pregnant or lactating women.
- Individuals currently on statins, ezetimibe, PCSK9 inhibitors, or any other lipid-lowering therapy.
- Allergic to mushrooms.
- Diagnosed with celiac disease or other chronic gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis).
- History of malignancy.
- Participation in another clinical trial within the last 3 months.
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, 1 recruiting
- Recruiting
Sana Noreen
Lahore, 54000
Sana Noreen, PhD, 03018661160, sananoreen.rizwan@gmail.com
About this study
This 12-week RCT investigates the hepatoprotective and immunomodulatory effects of Ganoderma lucidum combined with a probiotic-rich diet in adults with MAFLD, assessing liver enzymes, lipid profile, inflammation, gut microbiota, and oxidative stress.
Findings are expected to show dose-dependent improvements in hepatic fat, insulin resistance, and inflammatory markers, potentially reducing reliance on pharmacotherapy in
Read the detailed description
This study evaluates the therapeutic potential of (Ganoderma lucidum), combined with a probiotic-rich diet, to impose immunomodulatory and hepatoprotective effects in adults (35-65 years old) diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD). A 12-week randomized controlled trial (RCT) will be conducted, enrolling participants into three arms: a control group (starch capsules) and two intervention groups receiving either 250 mg or 500 mg of standardized Reishi extract daily. Primary outcomes include improvements in liver function markers (ALT, AST, ALP), lipid metabolism (LDL-C, HDL-C, triglycerides), and inflammatory biomarkers (CRP, IL-6). Secondary outcomes will assess gut microbiota composition (via 16S rRNA sequencing) and oxidative stress markers). Preliminary evidence suggests the Reishi-probiotic combination may significantly reduce hepatic fat accumulation (p<0.05) and serum LPS levels while increasing beneficial gut bacteria (e.g., Bifidobacterium spp.). We anticipate dose-dependent improvements in HOMA-IR scores and NF-κB suppression, correlating with triterpenoid bioavailability. If validated, this intervention could reduce reliance on pharmacotherapies by 30-40% in early-stage MAFLD, with synergistic effects observed between Beta-glucans and probiotic strains.
- Conditions
- Lipid Profile, Liver Biomarkers
- Being tested
- reishi mushroom- (Ganoderma lucidum), Placebo, Reishi mushroom dried powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reishi mushroom- (Ganoderma lucidum)Dietary supplement
Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken alongside a probiotic-rich diet.
PlaceboDietary supplement
STARCH CAPCULE
Reishi mushroom dried powderDietary supplement
Reishi mushroom dried powder ONCE A DAY
Reishi mushroom dried powderDietary supplement
Reishi mushroom dried powder TWICE A DAY
| Study group | Role | What they receive |
|---|---|---|
| Conventional Group (To) | Placebo comparator | starch capsules Receives: Dietary Supplement: Placebo |
| Experimental Group (T1) | Experimental | Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken alongside a probiotic-rich diet. Receives: Dietary Supplement: reishi mushroom- (Ganoderma lucidum); Dietary Supplement: Reishi mushroom dried powder |
| Experimental Group (T2) | Experimental | Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken twice alongside a probiotic-rich diet. Receives: Dietary Supplement: reishi mushroom- (Ganoderma lucidum); Dietary Supplement: Reishi mushroom dried powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
LIPID PROFILE
Fasting blood samples will be collected at baseline and post-intervention to measure serum levels
Measured: 12 WEEKS
Secondary outcomes (1)
Liver enzymes
- Alanine Aminotransferase (ALT): Assessed using validated methods
- Aspartate Aminotransferase (AST): Measured according to established protocols
- Alkaline Phosphatase (ALP): Activity determined using outlined methods
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start2 Oct 2025
- Primary completion31 Dec 2025
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid ProfileStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534241
- Sponsor's protocol ID
- UOL/IREB/25/13/0059
- Status last verified
- Oct 2025
- First submitted
- 9 Apr 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatoprotective Effects of Reishi Mushroom- (Ganoderma Lucidum) Among Metabolic Dysfunction-associated Fatty Liver Disease Patients
- ClinicalTrials.gov ID
- NCT07534241
- Acronym / sponsor ID
- UOL/IREB/25/13/0059
- Conditions
- Lipid Profile, Liver Biomarkers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 16 Apr 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 12-week RCT investigates the hepatoprotective and immunomodulatory effects of Ganoderma lucidum combined with a probiotic-rich diet in adults with MAFLD, assessing liver enzymes, lipid profile, inflammation, gut microbiota, and oxidative stress.
Findings are expected to show dose-dependent improvements in hepatic fat, insulin resistance, and inflammatory markers, potentially reducing reliance on pharmacotherapy in
Detailed description
This study evaluates the therapeutic potential of (Ganoderma lucidum), combined with a probiotic-rich diet, to impose immunomodulatory and hepatoprotective effects in adults (35-65 years old) diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD). A 12-week randomized controlled trial (RCT) will be conducted, enrolling participants into three arms: a control group (starch capsules) and two intervention groups receiving either 250 mg or 500 mg of standardized Reishi extract daily. Primary outcomes include improvements in liver function markers (ALT, AST, ALP), lipid metabolism (LDL-C, HDL-C, triglycerides), and inflammatory biomarkers (CRP, IL-6). Secondary outcomes will assess gut microbiota composition (via 16S rRNA sequencing) and oxidative stress markers). Preliminary evidence suggests the Reishi-probiotic combination may significantly reduce hepatic fat accumulation (p<0.05) and serum LPS levels while increasing beneficial gut bacteria (e.g., Bifidobacterium spp.). We anticipate dose-dependent improvements in HOMA-IR scores and NF-κB suppression, correlating with triterpenoid bioavailability. If validated, this intervention could reduce reliance on pharmacotherapies by 30-40% in early-stage MAFLD, with synergistic effects observed between Beta-glucans and probiotic strains.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Group (To) | Placebo comparator | Dietary Supplement: Placebostarch capsules |
| Experimental Group (T1) | Experimental | Dietary Supplement: reishi mushroom- (Ganoderma lucidum), Dietary Supplement: Reishi mushroom dried powderEach capsule contains 250 mg of Reishi mushroom dried powder, to be taken alongside a probiotic-rich diet. |
| Experimental Group (T2) | Experimental | Dietary Supplement: reishi mushroom- (Ganoderma lucidum), Dietary Supplement: Reishi mushroom dried powderEach capsule contains 250 mg of Reishi mushroom dried powder, to be taken twice alongside a probiotic-rich diet. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 35-65 years
- BMI between 18.5 and 30 kg/m².
- Complete Blood Count test ranges, WBC < 4,000-11,000 cells/µL, RBC Men < 4.5-6.0 / Women 4.0-5.5 million/µL, Hemoglobin: Men < 13.5-17.5 / Women 12.0-15.5 g/dL, Platelets < 150,000-450,000 cells/µL.
- 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.
Key exclusion criteria (7 listed)
- ● Diagnosed with severe cardiovascular disease, liver failure, or renal impairment.
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 |
|---|---|---|
| reishi mushroom- (Ganoderma lucidum)Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken alongside a probiotic-rich diet. | Dietary supplement | Experimental Group (T1), Experimental Group (T2) |
| PlaceboSTARCH CAPCULE | Dietary supplement | Conventional Group (To) |
| Reishi mushroom dried powderReishi mushroom dried powder ONCE A DAY | Dietary supplement | Experimental Group (T1) |
| Reishi mushroom dried powderReishi mushroom dried powder TWICE A DAY | Dietary supplement | Experimental Group (T2) |
Primary outcome
LIPID PROFILE
Time frame: 12 WEEKS
Fasting blood samples will be collected at baseline and post-intervention to measure serum levels
1 secondary outcome
Liver enzymes
Time frame: 12 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 30 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reishi mushroom- (Ganoderma lucidum) and Reishi mushroom dried powder in people with Lipid Profile and Liver Biomarkers, run by University of Lahore 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Jul 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?
Contact Sana Noreen, PhD (03018661160, sananoreen.rizwan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LIPID PROFILE (time frame: 12 WEEKS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2026.