NCT07534241

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
Last Updated

April 16, 2026

Status Verified

October 1, 2025

Enrollment Period

4 months

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Lipid ProfileLiver Biomarkers

Outcome Measures

Primary Outcomes (1)

  • LIPID PROFILE

    Fasting blood samples will be collected at baseline and post-intervention to measure serum levels

    12 WEEKS

Secondary Outcomes (1)

  • Liver enzymes

    12 weeks

Study Arms (3)

Conventional Group (To)

PLACEBO COMPARATOR

starch capsules

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.

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.

Dietary Supplement: reishi mushroom- (Ganoderma lucidum)Dietary Supplement: Reishi mushroom dried powder

Interventions

reishi mushroom- (Ganoderma lucidum)DIETARY_SUPPLEMENT

Each capsule contains 250 mg of Reishi mushroom dried powder, to be taken alongside a probiotic-rich diet.

Experimental Group (T1)Experimental Group (T2)
PlaceboDIETARY_SUPPLEMENT

STARCH CAPCULE

Conventional Group (To)
Reishi mushroom dried powderDIETARY_SUPPLEMENT

Reishi mushroom dried powder ONCE A DAY

Experimental Group (T1)

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • ● 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sana Noreen

Lahore, 54000, Pakistan

RECRUITING

Related Links

Central Study Contacts

Sana Noreen, PhD

CONTACT

03018661160sananoreen.rizwan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start

October 2, 2025

Primary Completion

February 1, 2026

Study Completion

April 15, 2026

Last Updated

April 16, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)