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亨廷顿病早期的时间限制饮食:一个为期12周的干预性临床试验协议

Russell G Wells¹, Lee E Neilson^1,2, Andrew W McHill³

¹Department of Neurology, Oregon Health and Science University, Portland, Oregon, United States of America.

|March 25, 2025

概括

这项试点研究探讨了时间限制饮食 (TRE) 作为亨廷顿病的潜在生活方式干预措施.

科学领域:

神经科学和神经病学神经科学和神经病学
代谢和营养科学代谢和营养科学
临床试验设计临床试验设计

背景情况:

亨廷顿病 (HD) 是一种进展性神经退行性疾病,没有治愈方法,需要新的治疗策略.
生活方式干预,如时间限制饮食 (TRE),通过改善细胞功能来改善神经退行性疾病的前景.
在患有HD的人群中,TRE的安全性,可行性和有效性尚未确定.

研究的目的:

评估12周时间限制饮食 (TRE) 干预措施对亨廷顿病参与者的坚持,安全性和可行性.
评估TRE对神经退行症生物标志物的初步影响,身体组成,以及对HD患者运动,认知和行为功能的临床测量.

主要方法:

一个前性的,开放的,单臂试点研究,涉及25名参与者,晚期prodromal或早期明显的HD.
参与者将坚持每天6-8小时的饮食窗口,持续12周.
数据收集包括坚持监测,身体组成,生命体征,安全实验室,神经退行生物标志物和标准化临床评估的HD症状.

主要成果:

该部分是在研究完成后填写的.
预期的结果包括证明TRE在HD患者群体中的安全性和可行性.
预计生物标志物和临床措施的初步改善,需要进一步调查.

结论:

预计这项试点研究将提供关于亨廷顿病患者时间限制饮食的安全性和可行性的关键数据.
这些发现将为更大的临床试验的设计提供信息,以确定TRE在减缓HD进展方面的治疗疗效.
TRE代表了一种有希望的,可访问的生活方式修改,可以补充亨廷顿病的现有管理策略.

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