Lipid Profile, Liver Biomarkers
Conditions
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTreishi mushroom- (Ganoderma lucidum)
Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken alongside a probiotic-rich diet.
DIETARY_SUPPLEMENTPlacebo
STARCH CAPCULE
DIETARY_SUPPLEMENTReishi mushroom dried powder
Reishi mushroom dried powder ONCE A DAY
Sponsors
University of Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* ● 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LIPID PROFILE | 12 WEEKS | Fasting blood samples will be collected at baseline and post-intervention to measure serum levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver enzymes | 12 weeks | * Alanine Aminotransferase (ALT): Assessed using validated methods * Aspartate Aminotransferase (AST): Measured according to established protocols * Alkaline Phosphatase (ALP): Activity determined using outlined methods |
Countries
Pakistan
Contacts
CONTACTSana Noreen, PhD
Outcome results
None listed