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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Starch | Placebo Comparator | Starch will be used as placebo comparator. |
|
| Intervention | Experimental | Ganoderma lucidum mushroom powder will be used as experimental capsule.Each capsule contains 1000 mg of mushroom dried powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Starch Placebo | Dietary Supplement | Intervention will invovle the the intake of Starch Placebo capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| LFTs | Liver Function Test inclusing ALT, AST and ALP will be mesuare. | Baseline (day one) - 12 weeks & 24 weeks (endline) |
| Lipid Profile | Lipid profile including LDL-C, HDL-C, triglycerides will be estimated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bibi Hajira, PhD | Khyber Medical University Peshawar | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Agriculture, Peshawar | Peshawar | Khyber Pakhtunkhwa | 25120 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26120584 | Result | 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. | |
| 28183232 | 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. |
| Label | URL |
|---|---|
| The dual role of Nrf2 in nonalcoholic fatty liver disease: regulation of antioxidant defenses and hepatic lipid metabolism. | View source |
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| Ganoderma lucidum | Dietary Supplement | Intervention will involve the intake of Ganoderma lucidum mushroom powder |
|
| 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. | Baseline (day one) - 12 weeks & 24 weeks (endline) |
| TNF-alpha | TNF-alpha will measured as marker of inflmmation. | Basline (day one)- 12 weeks & 24 weeks |
| Abdominal Ultrasound | Abdominal Ultrasound to asses fat acculumation in liver. | Basline (day one) - 12 weeks & 24 weeks |
| Triterpenoids and polysaccharide peptides-enriched Ganoderma lucidum: a randomized, double-blind placebo-controlled crossover study of its antioxidation and hepatoprotective efficacy in healthy volunteers | View source |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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