Impact of Ganoderma Lucidum on NRF2 Levels and Antioxidant Status in Metabolic Asscociated Fatty Liver Disease (GL-MAFLD-NRF2 Study)

NCT07564947 | Enrolling By Invitation DMC

• 1 other identifier: FNS-ECHSRB/2025-004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

MAFLD; Fatty Liver; Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD; Fatty Liver, Nonalcoholic; Fatty Liver Disease; Oxidative Stress; Inflammation

Keywords

MAFLD, Mushroom, Ganoderma Lucidum, NRF2

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (day one) - 12 week & 24 weeks

Secondary Outcomes (5)

• LFTs

  Baseline (day one) - 12 weeks & 24 weeks (endline)

• Lipid Profile

  Baseline (day one) - 12 weeks & 24 weeks (endline)

• NRF2 Protein levels

  Baseline (day one) - 12 weeks & 24 weeks (endline)

• TNF-alpha

  Basline (day one)- 12 weeks & 24 weeks

• Abdominal Ultrasound

  Basline (day one) - 12 weeks & 24 weeks

Study Arms (2)

Starch

PLACEBO COMPARATOR

Starch will be used as placebo comparator.

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

Dietary Supplement: Ganoderma lucidum

Interventions

Starch Placebo DIETARY_SUPPLEMENT

Intervention will invovle the the intake of Starch Placebo capsule

Starch

Ganoderma lucidum DIETARY_SUPPLEMENT

Intervention will involve the intake of Ganoderma lucidum mushroom powder

Intervention

Eligibility Criteria

• Age: 35 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Agriculture, Peshawar: lead

Study Sites (1)

The University of Agriculture, Peshawar

Peshawar, Khyber Pakhtunkhwa, 25120, Pakistan

Location

Related Publications (2)

• 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.

  PMID: 26120584 RESULT

• Chiu 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.

  PMID: 28183232 RESULT

Related Links

• The dual role of Nrf2 in nonalcoholic fatty liver disease: regulation of antioxidant defenses and hepatic lipid metabolism.
• Triterpenoids and polysaccharide peptides-enriched Ganoderma lucidum: a randomized, double-blind placebo-controlled crossover study of its antioxidation and hepatoprotective efficacy in healthy volunteers

MeSH Terms

Conditions

Fatty Liver; Non-alcoholic Fatty Liver Disease; Inflammation

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bibi Hajira, PhD

  Khyber Medical University Peshawar

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): April 20, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

PA (1)