TY - JOUR
T1 - Randomized-controlled trial of a modified Mediterranean dietary program for multiple sclerosis
T2 - A pilot study
AU - Katz Sand, Ilana
AU - Benn, Emma K. T
AU - Fabian, Michelle
AU - Fitzgerald, Kathryn C.
AU - Digga, Elise
AU - Deshpande, Richa
AU - Miller, Aaron
AU - Gallo, Samantha
AU - Arab, Lenore
N1 - Funding Information:
This study was funded by a Research Grant from the National Multiple Sclerosis Society (RG-1601-07277 to IKS).Dr. Katz Sand, Dr. Benn, Dr. Fitzgerald, Dr. Deshpande, Ms. Digga, Ms. Gallo, and Dr Arab has no disclosures. Dr. Fabian received an honorarium for an unbranded lecture sponsored by Biogen. Dr. Miller has acted as a consultant to Acorda Therapeutics, Biogen, CVS Caremark, EMD Serono, Genzyme, Gerson Lehrman Group, GlaxoSmithKline, and Nuron Biotech and has served on scientific advisory boards for HealthSTAR, Questcor, Sanofi-Aventis.
Funding Information:
This study was funded by a Research Grant from the National Multiple Sclerosis Society ( RG-1601-07277 to IKS).
Funding Information:
The authors would like to thank the clinicians and research coordinators at the Corinne Goldsmith Dickinson Center for MS (Stephen Krieger, Fred Lublin, Sylvia Klineova, Aliza Ben-Zacharia, Gretchen Mathewson, Rachel Brandstadter, Oluwasheyi Ayeni, Ilena George, Daniel Kurz, Sam Horng, Achilles Ntranos, Siobhan Flynn, Susan Filomena) for their assistance and support with study recruitment, James Sumowski for advising, the National MS Society for funding the study, and most importantly, all of the MS patients and their families who volunteered their time and effort to participate.
Publisher Copyright:
© 2019 Elsevier B.V.
PY - 2019/11
Y1 - 2019/11
N2 - Background: There is a high level of interest in the potential role of diet among the MS community. There is a limited level of evidence for a Mediterranean-style dietary pattern in MS; the feasibility of conducting studies using educational tools to deliver this type of intervention and study its effects is unknown. Objectives: To establish clinical trial feasibility for future studies utilizing educational delivery of a dietary intervention in MS; to explore the effects of a modified Mediterranean dietary intervention in MS. Methods: We randomly assigned women with MS to follow/not follow the prescribed modified Mediterranean dietary intervention for 6 months, delivered through educational sessions. The diet encouraged the intake of fish and other foods high in poly- and monounsaturated fats, fresh fruits, vegetables, and whole grains and eliminated meat, dairy, and most processed foods and limited salt intake to <2 g/day. Primary endpoints related to meeting target enrollment within the specified time frame, adherence, and study completion. Clinical endpoints were evaluated in an exploratory fashion. Results: We screened 128 potential participants and enrolled 36 within 9 months, surpassing target enrollment of 30 participants at a single center in 1 year. Self-reported adherence was excellent (90.3%), with an overall study completion rate of 94.4%. The intervention group exhibited a statistically significant decline in the trajectory of Neurological Fatigue Index-MS scores (p = 0.01), a trend toward reduced Multiple Sclerosis Impact Scale-29 scores that became significant after outlier removal (p = 0.12; p = 0.023), and a reduction in Expanded Disability Status Scale (p = 0.01) over time as compared to the non-intervention group. Conclusions: It is reasonable to expect a high level of interest and commitment to this type of dietary intervention study in MS, and feasible to deliver it purely through education in a clinical setting with high adherence levels despite restrictive requirements. In this pilot study, a modified Mediterranean dietary intervention reduced fatigue, impact of MS symptoms, and disability. Further work is needed.
AB - Background: There is a high level of interest in the potential role of diet among the MS community. There is a limited level of evidence for a Mediterranean-style dietary pattern in MS; the feasibility of conducting studies using educational tools to deliver this type of intervention and study its effects is unknown. Objectives: To establish clinical trial feasibility for future studies utilizing educational delivery of a dietary intervention in MS; to explore the effects of a modified Mediterranean dietary intervention in MS. Methods: We randomly assigned women with MS to follow/not follow the prescribed modified Mediterranean dietary intervention for 6 months, delivered through educational sessions. The diet encouraged the intake of fish and other foods high in poly- and monounsaturated fats, fresh fruits, vegetables, and whole grains and eliminated meat, dairy, and most processed foods and limited salt intake to <2 g/day. Primary endpoints related to meeting target enrollment within the specified time frame, adherence, and study completion. Clinical endpoints were evaluated in an exploratory fashion. Results: We screened 128 potential participants and enrolled 36 within 9 months, surpassing target enrollment of 30 participants at a single center in 1 year. Self-reported adherence was excellent (90.3%), with an overall study completion rate of 94.4%. The intervention group exhibited a statistically significant decline in the trajectory of Neurological Fatigue Index-MS scores (p = 0.01), a trend toward reduced Multiple Sclerosis Impact Scale-29 scores that became significant after outlier removal (p = 0.12; p = 0.023), and a reduction in Expanded Disability Status Scale (p = 0.01) over time as compared to the non-intervention group. Conclusions: It is reasonable to expect a high level of interest and commitment to this type of dietary intervention study in MS, and feasible to deliver it purely through education in a clinical setting with high adherence levels despite restrictive requirements. In this pilot study, a modified Mediterranean dietary intervention reduced fatigue, impact of MS symptoms, and disability. Further work is needed.
KW - Clinical trial
KW - Diet
KW - Fatigue
KW - Mediterranean
KW - Multiple sclerosis
UR - http://www.scopus.com/inward/record.url?scp=85073025929&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85073025929&partnerID=8YFLogxK
U2 - 10.1016/j.msard.2019.101403
DO - 10.1016/j.msard.2019.101403
M3 - Article
C2 - 31610401
AN - SCOPUS:85073025929
SN - 2211-0348
VL - 36
JO - Multiple Sclerosis and Related Disorders
JF - Multiple Sclerosis and Related Disorders
M1 - 101403
ER -