MAFLD, Fatty Liver, Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD, Fatty Liver, Nonalcoholic, Fatty Liver Disease, Oxidative Stress, Inflammation
Conditions
Keywords
MAFLD, Mushroom, Ganoderma Lucidum, NRF2
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.
Detailed description
The prevalence of non-alcoholic fatty liver disease (NAFLD) is increasing worldwide. Unfortunately, for the treatment of NAFLD no FDA-approved drugs are available currently. Therefore, natural products are currently used as alternative treatments for fatty liver disease. Ganoderma lucidum is a traditional, medicinal edible mushroom with significant health benefits. It contains bioactive compounds such as polysaccharides, polyphenols and triterpenoids which have significant antioxidant, anti-inflammatory and anti-cancer properties. Previous studies have shown the protective effect of GL extract against cancer, diabetes and hepatotoxicity. However, limited evidence is available on the specific interaction of these compounds with Nrf2 pathway a key regulator of cellular redox balance and detoxification has not been extensively studied. Therefore, the present study aims to investigate the effect of GL extract on the Nrf2 pathway in human experimental models. By elucidating the molecular mechanisms involved, this study could pave the way for the development of new, natural, and effective interventions for a variety of chronic diseases driven by oxidative stress and inflammation. Moreover, the findings may contribute to the broader field of nutraceutical and their role in supporting health at the cellular level. Previous studies in animal models have shown the potential lipid lowering mechanism of GLP. However, few human intervention studies have been conducted on the effect of GL on lipid lowering pathways in humans. Therefore, the present study aims to investigate the effect of GL on lipid lowering mechanisms in human studies. This study will provide new knowledge on the potential for the mushroom extract on liver, inflammatory and oxidative stress biomarkers that may be of benefit for the prevention and control of non-alcoholic fatty liver.
Interventions
DIETARY_SUPPLEMENTStarch Placebo
Intervention will invovle the the intake of Starch Placebo capsule
DIETARY_SUPPLEMENTGanoderma lucidum
Intervention will involve the intake of Ganoderma lucidum mushroom powder
Sponsors
University of Agriculture, Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Total Antioxidant Capacity (T-AOC) | Baseline (day one) - 12 week & 24 weeks | Plasma Total Antioxidant Capacity (T-AOC) will be measured to determined the antioxidative effect of ganoderma mushroom in participants with fatty liver. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LFTs | Baseline (day one) - 12 weeks & 24 weeks (endline) | Liver Function Test inclusing ALT, AST and ALP will be mesuare. |
| Lipid Profile | Baseline (day one) - 12 weeks & 24 weeks (endline) | Lipid profile including LDL-C, HDL-C, triglycerides will be estimated. |
| NRF2 Protein levels | Baseline (day one) - 12 weeks & 24 weeks (endline) | NRF2 Protein levels will be meausred as key regulator of cellular redox and detoxification balance. |
| TNF-alpha | Basline (day one)- 12 weeks & 24 weeks | TNF-alpha will measured as marker of inflmmation. |
| Abdominal Ultrasound | Basline (day one) - 12 weeks & 24 weeks | Abdominal Ultrasound to asses fat acculumation in liver. |
Countries
Pakistan
Contacts
STUDY_CHAIRBibi Hajira, PhD
Khyber Medical University Peshawar
Outcome results
None listed