Impact of Ganoderma Lucidum on NRF2 Levels and Antioxidant Status in Metabolic Asscociated Fatty Liver Disease (GL-MAFLD-NRF2 Study) (GL-MAFLD-NFR2)
Impatc of Ganoderma Lucidum on NRF2 Levels and Antioxidant Status in Metabolic Asscociated Fatty Liver Disease
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Khyber Pakhtunkhwa
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Peshawar, Khyber Pakhtunkhwa, Pakistan, 25120
- The University of Agriculture, Peshawar
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: Starch
Starch will be used as placebo comparator.
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Intervention will invovle the the intake of Starch Placebo capsule
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Expérimental: Intervention
Ganoderma lucidum mushroom powder will be used as experimental capsule.Each capsule contains 1000 mg of mushroom dried powder
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Intervention will involve the intake of Ganoderma lucidum mushroom powder
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Plasma Total Antioxidant Capacity (T-AOC)
Délai: Baseline (day one) - 12 week & 24 weeks
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Plasma Total Antioxidant Capacity (T-AOC) will be measured to determined the antioxidative effect of ganoderma mushroom in participants with fatty liver.
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Baseline (day one) - 12 week & 24 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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LFTs
Délai: Baseline (day one) - 12 weeks & 24 weeks (endline)
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Liver Function Test inclusing ALT, AST and ALP will be mesuare.
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Baseline (day one) - 12 weeks & 24 weeks (endline)
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Lipid Profile
Délai: Baseline (day one) - 12 weeks & 24 weeks (endline)
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Lipid profile including LDL-C, HDL-C, triglycerides will be estimated.
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Baseline (day one) - 12 weeks & 24 weeks (endline)
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NRF2 Protein levels
Délai: Baseline (day one) - 12 weeks & 24 weeks (endline)
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NRF2 Protein levels will be meausred as key regulator of cellular redox and detoxification balance.
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Baseline (day one) - 12 weeks & 24 weeks (endline)
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TNF-alpha
Délai: Basline (day one)- 12 weeks & 24 weeks
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TNF-alpha will measured as marker of inflmmation.
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Basline (day one)- 12 weeks & 24 weeks
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Abdominal Ultrasound
Délai: Basline (day one) - 12 weeks & 24 weeks
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Abdominal Ultrasound to asses fat acculumation in liver.
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Basline (day one) - 12 weeks & 24 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Bibi Hajira, PhD, Khyber Medical University Peshawar
Publications et liens utiles
Publications générales
- 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.
- 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.
Liens utiles
- 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
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FNS-ECHSRB/2025-004
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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