Effect of Mediterranean and Western diets on fatigue in patients with autoimmune hepatitis: Protocol for a randomized crossover diet intervention trial

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-05-12 DOI:10.1016/j.cct.2025.107951

Craig Lammert , Siri Vuppalanchi , Kelsey Green , Nadia Blessing , Archita P Desai , Timothy Stump , Nana Gletsu Miller , Lisa Spence , Amy Wright

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引用次数: 0

Abstract

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.

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地中海和西方饮食对自身免疫性肝炎患者疲劳的影响：一项随机交叉饮食干预试验方案

背景：疲劳是自身免疫性肝炎（AIH）患者的衰弱症状，目前尚无有效的治疗干预措施。地中海饮食（MD）的抗炎特性可能提供一种潜在的非药物方法来减少疲劳。本文概述了一项随机交叉饮食干预试验的基本原理、设计和方案，以评估地中海饮食（MD）与西方饮食（WD）对AIH患者疲劳水平的影响。方法：在这项交叉研究中，48名受试者将随机分为MD组或WD组。在完成第一组后，参与者将切换到相反的饮食。研究小组（包括PI和协调员）和患者将对饮食干预保持盲法。主要结果将是每次饮食干预期间PROMIS®-29 Profile v.2.0调查中疲劳成分评分的变化。次要结局包括个体promiso -29结构域评分、精神和身体总结评分、循环炎症标志物（c反应蛋白等）、关键肝脏血清生物标志物水平（丙氨酸转氨酶、免疫球蛋白G、总蛋白）、粪便微生物组（16S）和短链脂肪酸、肝脏僵硬和脂肪变性、血清铁研究（铁蛋白、总铁结合能力、转铁蛋白饱和度、血红蛋白）的变化。以及血清维生素D和镁水平等营养指标。结论：如果地中海饮食（MD）与PROMIS®-29调查中疲劳成分评分的统计学显著降低有关，那么它可以作为一种有希望的非药物干预措施来减少AIH患者的疲劳，为改善这一人群的生活质量提供了一种新的方法。临床试验：政府ID: NCT06250309。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.