Contemporary clinical trials · 2025
Effect of Mediterranean and Western diets on fatigue in patients with autoimmune hepatitis: Protocol for a randomized crossover diet intervention trial.
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Lammert Craig, Vuppalanchi Siri, Green Kelsey, Blessing Nadia, Desai Archita P, Stump Timothy, Miller Nana Gletsu, Spence Lisa, Wright Amy
Аннотация
BACKGROUND: Fatigue is a debilitating symptom in patients with autoimmune hepatitis (AIH), and no effective treatment interventions are currently available. The anti-inflammatory properties of a Mediterranean diet (MD) may offer a potential non-pharmacological approach to reducing fatigue. This paper outlines the rationale, design, and protocol for a randomized crossover diet intervention trial to assess the effects of Mediterranean diet (MD) compared to a Western diet (WD) on fatigue levels in patients with AIH.
METHODS: In this crossover study, 48 subjects will be randomized to start either a MD or WD arm. After completing the initial arm, participants will switch to the opposite diet. The study team (including the PI and coordinator) and patients will remain blinded to the dietary intervention. The primary outcome will be the change in the fatigue component score of the PROMIS®-29 Profile v.2.0 survey during each dietary intervention. Secondary outcomes include changes in individual PROMIS-29 domain scores, mental and physical summary scores, circulating markers of inflammation (C-reactive protein and others), key liver serum biomarker levels (alanine aminotransferase, immunoglobulin G, total protein), stool microbiome (16S) and short-chain fatty acids, liver stiffness and steatosis, serum iron studies (ferritin, total iron binding capacity, transferrin saturation, hemoglobin), and nutritional markers such as serum vitamin D and magnesium levels.
CONCLUSION: If the Mediterranean diet (MD) is associated with a statistically significant decrease in the fatigue component score of the PROMIS®-29 survey, it could serve as a promising non-pharmacological intervention to reduce fatigue in AIH patients, offering a novel approach to improve quality of life in this population.
CLINICALTRIALS: gov ID: NCT06250309.
METHODS: In this crossover study, 48 subjects will be randomized to start either a MD or WD arm. After completing the initial arm, participants will switch to the opposite diet. The study team (including the PI and coordinator) and patients will remain blinded to the dietary intervention. The primary outcome will be the change in the fatigue component score of the PROMIS®-29 Profile v.2.0 survey during each dietary intervention. Secondary outcomes include changes in individual PROMIS-29 domain scores, mental and physical summary scores, circulating markers of inflammation (C-reactive protein and others), key liver serum biomarker levels (alanine aminotransferase, immunoglobulin G, total protein), stool microbiome (16S) and short-chain fatty acids, liver stiffness and steatosis, serum iron studies (ferritin, total iron binding capacity, transferrin saturation, hemoglobin), and nutritional markers such as serum vitamin D and magnesium levels.
CONCLUSION: If the Mediterranean diet (MD) is associated with a statistically significant decrease in the fatigue component score of the PROMIS®-29 survey, it could serve as a promising non-pharmacological intervention to reduce fatigue in AIH patients, offering a novel approach to improve quality of life in this population.
CLINICALTRIALS: gov ID: NCT06250309.