地中海和西方饮食对自身免疫性肝炎患者疲劳的影响:随机交叉饮食干预试验的协议
Craig Lammert1, Siri Vuppalanchi1, Kelsey Green1
1Department of Medicine, Indiana University, United States of America.
Contemporary clinical trials
|May 14, 2025
概括
这项研究调查了地中海饮食 (MD) 是否可以减少自身免疫性肝炎 (AIH) 患者的衰弱性疲劳. 研究人员将在随机交叉试验中将MD与西方饮食 (WD) 进行比较,以评估疲劳水平和其他健康标志物.
科学领域:
- 营养科学 营养科学
- 肝病学 肝病学是一种肝病学.
- 临床试验 临床试验
背景情况:
- 疲劳是自身免疫性肝炎 (AIH) 患者显著且无法治疗的症状.
- 地中海饮食 (MD),以其抗炎性质而闻名,为管理AIH相关的疲劳提供了一个潜在的非药物战略.
- 目前对AIH疲劳的治疗选择有限,需要探索新的干预措施.
研究的目的:
- 为了评估地中海饮食 (MD) 与西方饮食 (WD) 相比在减少自身免疫性肝炎 (AIH) 患者的疲劳方面的疗效.
- 评估饮食干预对各种健康标志物的影响,包括AIH患者的炎症,肝功能和营养状况.
主要方法:
- 一个随机交叉试验,涉及48名AIH患者,参与者被分配到MD或WD,然后切换到替代饮食.
- 盲目干预,以确保对饮食对疲劳影响的公正评估.
- 通过PROMIS®-29疲劳得分的变化来衡量主要结果;次要结果包括炎症标志物,肝脏生物标志物,微生物组分析和营养状况.
主要成果:
- 临床试验的注册:NCT06250309.9. 临床试验的注册
- 关于主要和次要结果的数据正在等待试验完成.
结论:
- 在统计学上显著地减少使用MD的疲劳得分,可以将其确立为AIH的有价值的非药物干预措施.
- 这种饮食方法可能为患有自身免疫性肝炎的个人提供一种新的方法来提高生活质量.
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