Conducting dietary intervention trials in people with multiple sclerosis: lessons learned and a path forward

Authors: FITZGERALD, KATHRYN - Johns Hopkins University School Of Medicine; SAND, ILANA - Mount Sinai Medical Center; SENDERS, ANGELA - National College Of Natural Medicine; SPAIN, REBECCA - Oregon Health & Science University; GIESSER, BARBARA - Geffen School Of Medicine; Sullivan, Patrick; Baer, David; LAROCCA, NICHOLAS - National Multiple Sclerosis Society; ZACKOWSKI, KATHLEEN - National Multiple Sclerosis Society; MOWRY, ELLEN - Johns Hopkins University School Of Medicine

Submitted to: Multiple Sclerosis and Related Disorders
Publication Type: Review Article
Publication Acceptance Date: 10/25/2019
Publication Date: 1/1/2020
Citation: Fitzgerald, K.C., Sand, I.K., Senders, A., Spain, R., Giesser, B., Sullivan, P.J., Baer, D.J., Larocca, N., Zackowski, K., Mowry, E.M. 2020. Conducting dietary intervention trials in people with multiple sclerosis: lessons learned and a path forward. Multiple Sclerosis and Related Disorders. 37. https://doi.org/10.1016/j.msard.2019.101478.
DOI: https://doi.org/10.1016/j.msard.2019.101478

Interpretive Summary: The prognosis of multiple sclerosis (MS) is highly variable. While anecdotal evidence implicates a possible role of diet in MS disease modification, scientific evidence that evaluates this hypothesis is sparse. Dietary and nutritional factors on multiple sclerosis (MS) prognosis is of interest to both patients and doctors; differences in diet are thought to potentially contribute to disease evolution over time. However, studying diet, especially in people with MS, introduces a certain level of methodologic complexity. In this review, we focus on methodological aspects relevant to one type of diet study, the dietary intervention, given our experience in the conduct of such studies and many of the challenges we had encountered in the realization of the trials. Specifically, we summarize key aspects of study design and important considerations for the conduct of dietary intervention trials in people with MS, regardless of the specifics of the actual study (e.g. the particular diet of interest, target MS population, etc.). We discuss strategies for improving rigor in the conduct of dietary studies in people with MS as well as candidate methods of delivery for these types of interventions. Finally, we provide an overview of points to consider when selecting study endpoints for dietary interventions in people with MS. This information will be of interest to patients, clinicians, and allied health professionals working to improve the lives of people with multiple sclerosis.

Technical Abstract: Disease course in people with multiple sclerosis (MS) is heterogeneous. The impact of dietary and nutritional factors on MS prognosis is of interest to both patients and clinicians; differences in diet are hypothesized to contribute to disease evolution over time. However, studying diet, especially in people with MS, introduces methodologic complexity that should be recognized. In this review, we focus on methodological aspects relevant to the conduct of dietary interventions in people with MS, given our experience in leading such studies and the challenges we encountered in the realization of this work. We summarize key aspects of study design and important considerations, regardless of the specifics of the actual study (e.g. the particular diet of interest, target MS population, etc.). We discuss strategies for the design of the intervention as well as the selection of appropriate study endpoints. Finally, we provide an overview of strategies to improve the rigor of conducting dietary studies in people with MS.