This RCT investigates the impact of Ganoderma lucidum on antioxidant staus, NRF2 levels and lipid metabolism in individuals with Metabolic Associated Fatty Liver Disease.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
40
Intervention will invovle the the intake of Starch Placebo capsule
Intervention will involve the intake of Ganoderma lucidum mushroom powder
The University of Agriculture, Peshawar
Peshawar, Khyber Pakhtunkhwa, Pakistan
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.
Time frame: Baseline (day one) - 12 week & 24 weeks
LFTs
Liver Function Test inclusing ALT, AST and ALP will be mesuare.
Time frame: Baseline (day one) - 12 weeks & 24 weeks (endline)
Lipid Profile
Lipid profile including LDL-C, HDL-C, triglycerides will be estimated.
Time frame: Baseline (day one) - 12 weeks & 24 weeks (endline)
NRF2 Protein levels
NRF2 Protein levels will be meausred as key regulator of cellular redox and detoxification balance.
Time frame: Baseline (day one) - 12 weeks & 24 weeks (endline)
TNF-alpha
TNF-alpha will measured as marker of inflmmation.
Time frame: Basline (day one)- 12 weeks & 24 weeks
Abdominal Ultrasound
Abdominal Ultrasound to asses fat acculumation in liver.
Time frame: Basline (day one) - 12 weeks & 24 weeks
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