Sheffler Julia L, Arjmandi Bahram, Quinn Jamie, Hajcak Greg, Vied Cynthia, Akhavan Neda, Naar Sylvie
Florida State University, Tallahassee, USA.
Pilot Feasibility Stud. 2022 Jan 22;8(1):16. doi: 10.1186/s40814-022-00970-z.
The National Institutes of Health Obesity-Related Behavioral Intervention Trials model for intervention development was used to establish the feasibility and proof of concept of a motivational ketogenic nutrition adherence program for older adults with mild cognitive impairment.
This was a single-arm, single-center feasibility trial. A comprehensive assessment protocol, including a clinical interview, neuropsychological testing, and genetic sequencing was used as an initial screening. Nine participants (aged 64-75) with possible amnestic mild cognitive impairment were consented for the intervention. Participants completed pre- and post-intervention neuropsychological assessments using the updated Repeatable Battery for Assessment of Neuropsychological Status. Participants tracked their macronutrient consumption using food diaries and ketone levels using urinalysis test strips daily. Mood and other psychosocial variables were collected through surveys, and qualitative exit interviews were completed.
100% of participants who began the trial completed the 6-week ketogenic nutrition adherence program, including completion of the pre- and post-assessments. Eight participants achieved measurable levels of ketones during the program. The average self-rated adherence across the program was 8.7 out of 10. A Wilcoxon Signed-Rank test demonstrated significant improvement in cognitive performance from baseline (median = 88) to follow up (median = 96, Z = - 2.26, p = .024). The average difference in cognitive performance from baseline to follow-up was - 7.33 (95% CI - 12.85, - 1.82).
Results supported the feasibility for moving to the next phase and demonstrated proof of concept for the intervention. The next step is a randomized pilot trial to test clinical signals of effect compared to a control condition.
This trial was retrospectively registered with clinicaltrials.gov on July 13, 2021. The trial number is NCT04968041.
采用美国国立卫生研究院肥胖相关行为干预试验模型进行干预开发，以确定针对轻度认知障碍老年人的动机性生酮营养依从性计划的可行性和概念验证。
这是一项单臂、单中心可行性试验。采用包括临床访谈、神经心理学测试和基因测序在内的综合评估方案进行初始筛查。9名年龄在64 - 75岁之间、可能患有遗忘型轻度认知障碍的参与者同意接受干预。参与者使用更新后的可重复神经心理状态评估量表完成干预前后的神经心理学评估。参与者通过食物日记记录其常量营养素摄入量，并每天使用尿液分析试纸检测酮水平。通过调查收集情绪和其他社会心理变量，并完成定性退出访谈。
100%开始试验的参与者完成了为期6周的生酮营养依从性计划，包括完成前后评估。8名参与者在计划期间达到了可测量的酮水平。整个计划中自我评定的平均依从性为10分中的8.7分。Wilcoxon符号秩检验显示，从基线（中位数 = 88）到随访（中位数 = 96，Z = - 2.26，p = 0.024），认知表现有显著改善。从基线到随访，认知表现的平均差异为 - 7.33（95%可信区间 - 12.85， - 1.82）。
结果支持进入下一阶段的可行性，并证明了该干预的概念验证。下一步是进行随机试点试验，以测试与对照条件相比的临床效果信号。
本试验于2021年7月13日在clinicaltrials.gov上进行回顾性注册。试验编号为NCT04968041。
