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Набор по приглашению NCT07564947

Impact of Ganoderma Lucidum on NRF2 Levels and Antioxidant Status in Metabolic Asscociated Fatty Liver Disease (GL-MAFLD-NRF2 Study)

Без фазы С лечением MAFLD Fatty Liver Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD Fatty Liver, Nonalcoholic

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Starch Placebo, Ganoderma lucidum.
Кому может быть актуально
Состояния в реестре: MAFLD, Fatty Liver, Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD, Fatty Liver, Nonalcoholic. Базовые параметры: 35 лет — 49 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Impatc of Ganoderma Lucidum on NRF2 Levels and Antioxidant Status in Metabolic Asscociated Fatty Liver Disease

Обзор

This RCT investigates the impact of Ganoderma lucidum on antioxidant staus, NRF2 levels and lipid metabolism in individuals with Metabolic Associated Fatty Liver Disease.

Подробное описание

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.

Вмешательства

  • Пищевая добавка Starch Placebo
    Intervention will invovle the the intake of Starch Placebo capsule
  • Пищевая добавка Ganoderma lucidum
    Intervention will involve the intake of Ganoderma lucidum mushroom powder

Первичные конечные точки

  • Plasma Total Antioxidant Capacity (T-AOC) [Срок оценки: Baseline (day one) - 12 week & 24 weeks]
Вторичные конечные точки (5)
  • LFTs [Срок оценки: Baseline (day one) - 12 weeks & 24 weeks (endline)]
  • Lipid Profile [Срок оценки: Baseline (day one) - 12 weeks & 24 weeks (endline)]
  • NRF2 Protein levels [Срок оценки: Baseline (day one) - 12 weeks & 24 weeks (endline)]
  • TNF-alpha [Срок оценки: Basline (day one)- 12 weeks & 24 weeks]
  • Abdominal Ultrasound [Срок оценки: Basline (day one) - 12 weeks & 24 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Профилактика

Центры проведения

Пакистан · 1 центр
  • The University of Agriculture, Peshawar — Peshawar

Публикации

  • 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. PMID 26120584
  • 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. PMID 28183232

Идентификаторы

NCT: NCT07564947 · FNS-ECHSRB/2025-004

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗