Highlights
- •Fasting-mimicking diets are safe among people with multiple sclerosis.
- •Adherence to calorie restriction diets is poor despite clinical support.
- •Poor dietary adherence is a challenge and remains a barrier to research outcomes.
- •Strict adherence to time-restricted feeding may be more feasible than calorie restriction.
Abstract
Background
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.
Objective
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).
Methods
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.
Results
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.
Conclusion
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
Keywords
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Article info
Publication history
Published online: May 05, 2020
Accepted:
April 22,
2020
Received in revised form:
April 14,
2020
Received:
February 6,
2020
Identification
Copyright
© 2020 Elsevier B.V. All rights reserved.
