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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Khyber Pakhtunkhwa
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Peshawar, Khyber Pakhtunkhwa, Pakistan, 25120
- The University of Agriculture, Peshawar
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Plasma Total Antioxidant Capacity (T-AOC)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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LFTs
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Cattedra di studio: Bibi Hajira, PhD, Khyber Medical University Peshawar
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Collegamenti utili
- 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
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- FNS-ECHSRB/2025-004
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Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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