An interventional study of reishi mushroom- (Ganoderma lucidum) and Placebo in Lipid Profile and Liver Biomarkers, sponsored by University of Lahore. Recruiting at 1 site in Pakistan. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by University of Lahore · Not applicable, Interventional, and Supportive care
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
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.
Exclusion Criteria:
● Diagnosed with severe cardiovascular disease, liver failure, or renal impairment.
starch capsules
Dietary Supplement: Placebo
Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken alongside a probiotic-rich diet.
Dietary Supplement: reishi mushroom- (Ganoderma lucidum) · Dietary Supplement: Reishi mushroom dried powder
Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken twice alongside a probiotic-rich diet.
Dietary Supplement: reishi mushroom- (Ganoderma lucidum) · Dietary Supplement: Reishi mushroom dried powder
Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken alongside a probiotic-rich diet.
STARCH CAPCULE
Reishi mushroom dried powder ONCE A DAY
Reishi mushroom dried powder TWICE A DAY
LIPID PROFILE
Fasting blood samples will be collected at baseline and post-intervention to measure serum levels
Time frame: 12 WEEKS
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
Time frame: 12 weeks
Plan to share: No
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University of Lahore