Roman S N, Fitzgerald K C, Beier M, Mowry E M
Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State.
Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United State.
Mult Scler Relat Disord. 2020 Jul;42:102149. doi: 10.1016/j.msard.2020.102149. Epub 2020 May 6.
Fasting-mimicking diets have shown promise in experimental autoimmune encephalitis and are currently being investigated among people with multiple sclerosis (MS). Ensuring adherence to diet changes is critical to determining the efficacy of such interventions.
Our primary aim was to evaluate the safety and feasibility of several fasting-mimicking diets and investigate whether various levels of clinical support improve diet adherence among people with MS. Secondarily, this study evaluated the impact of fasting-mimicking diets on weight and patient-reported outcomes (PROs).
We conducted three pilot studies (two randomized controlled for 6 months; one randomized with transition to single arm) restricting either the amount or timing of calorie intake over 24 or 48 weeks. Interventions included calorie restriction (daily or intermittently) or time-restricted feeding. Adherence measures varied across studies but were collected at study visits along with weight and PRO data.
A total of 90 participants enrolled; 70 completed the studies, with no serious adverse events reported. Overall adherence to the calorie restriction diets was poor. When participants were tasked with maintaining a diet in a pragmatic setting, neither previously completed intense clinical support and education, nor weekly electronic communication throughout the diet period appeared to improve diet adherence. Participants who were able to adhere to a calorie restriction diet predictably lost weight. In contrast to calorie restriction, adherence to a time-restricted feeding (TRF) diet was relatively good. No statistically significant changes in PROs were observed in an intention-to-treat analysis.
The role diet may play in clinical outcomes in MS remains unknown, as class I evidence is lacking. Diet adherence remains a primary barrier to the feasible conduct of large, randomized controlled diet trials. Strict adherence to a TRF dietary change may be more feasible than calorie restriction and should be considered in future fasting-mimicking diet trials. ClinicalTrials.gov Registry:A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis - NCT02647502. A Pragmatic Trial of Dietary Programs in People with Multiple Sclerosis (MS) - NCT02846558.
模拟禁食饮食在实验性自身免疫性脑脊髓炎中已显示出前景，目前正在多发性硬化症（MS）患者中进行研究。确保坚持饮食改变对于确定此类干预措施的疗效至关重要。
我们的主要目的是评估几种模拟禁食饮食的安全性和可行性，并调查不同水平的临床支持是否能提高MS患者的饮食依从性。其次，本研究评估了模拟禁食饮食对体重和患者报告结局（PROs）的影响。
我们进行了三项试点研究（两项为期6个月的随机对照试验；一项随机试验并过渡为单臂试验），在24周或48周内限制热量摄入的量或时间。干预措施包括热量限制（每日或间歇性）或限时进食。不同研究中的依从性测量方法各不相同，但在研究访视时与体重和PRO数据一起收集。
共有90名参与者入组；70名完成了研究，未报告严重不良事件。总体而言，对热量限制饮食的依从性较差。当参与者在实际环境中负责维持饮食时，无论是先前完成的强化临床支持和教育，还是在整个饮食期间每周进行电子通信，似乎都没有提高饮食依从性。能够坚持热量限制饮食的参与者可预见地减轻了体重。与热量限制相反，对限时进食（TRF）饮食的依从性相对较好。在意向性分析中未观察到PROs有统计学意义的变化。
由于缺乏I类证据，饮食在MS临床结局中可能发挥的作用仍然未知。饮食依从性仍然是进行大型随机对照饮食试验的主要障碍。严格坚持TRF饮食改变可能比热量限制更可行，应在未来的模拟禁食饮食试验中予以考虑。ClinicalTrials.gov注册编号：多发性硬化症间歇性热量限制的试点研究 - NCT02647502。多发性硬化症（MS）患者饮食方案的实用试验 - NCT02846558。
