随机对照试验与并行过程评估和健康经济分析,以评估营养管理干预措施,OptiCALS,用于肌缩侧面硬化症患者:研究协议
Arron Peace1, David Alexander White2, Gemma Hackney1
1Clinical Trials Research Unit, Sheffield Centre for Health and Related Research, The University of Sheffield, Sheffield, UK.
BMJ open
|May 28, 2025
概括
这项研究旨在调查高热量饮食是否能改善肌缩侧面硬化症 (ALS) 患者的功能. 早期结果表明,饮食干预可能有利于面临体重减轻和功能衰退的ALS患者.
科学领域:
- 神经学 神经学
- 临床营养学 临床营养学
- 公共卫生 公共卫生
背景情况:
- 肌缩侧面硬化症 (ALS) 是一种进展性神经退行性疾病,导致肌肉衰弱和快速死亡.
- 由于增加的能量需求和食困难,ALS患者的体重减轻很常见,与预后较差相关.
- 有证据表明,高热量饮食可能会对ALS的疾病过程产生积极影响,因此需要进一步调查.
研究的目的:
- 评估早期高卡路里饮食干预对ALS患者功能结果的有效性.
- 评估"食物优先"方法在使用补充剂之前实现热量目标的影响.
- 为了确定热量摄入的积极管理是否可以改善ALS患者的功能状态.
主要方法:
- 一项随机对照试验,涉及英国和爱尔兰ALS中心的259名参与者.
- 两个手臂:标准护理与OptiCALS干预高热量饮食的标准护理.
- 12个月的随访评估功能变化通过修订ALS功能评级尺度,以及像生活质量和生存等二次结果.
主要成果:
- 该研究正在进行中,招聘将于2025年9月结束,并于2026年9月进行后续调查.
- 主要结局是12个月的功能变化.
- 二次结果包括生活质量,卡路里摄入量,体重,胃口术的时间和生存率.
结论:
- 这项研究旨在提供关于早期营养干预对ALS治疗的好处的关键证据.
- 预计这些发现将为临床实践提供信息,并改善ALS患者的生活质量.
- 结果将通过同行评审的出版物和会议演讲传播.
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