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Mult Scler Relat Disord. 2019 Sep 24;36:101403.
doi: 10.1016/j.msard.2019.101403.
Randomized-controlled trial of a modified Mediterranean dietary program for multiple sclerosis: A pilot study.
Katz Sand I1, Benn EKT2, Fabian M3, Fitzgerald KC4, Digga E3, Deshpande R2, Miller A3, Gallo S5, Arab L6.
Abstract
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.
KEYWORDS:
Clinical trial; Diet; Fatigue; Mediterranean; Multiple sclerosis
doi: 10.1016/j.msard.2019.101403.
Randomized-controlled trial of a modified Mediterranean dietary program for multiple sclerosis: A pilot study.
Katz Sand I1, Benn EKT2, Fabian M3, Fitzgerald KC4, Digga E3, Deshpande R2, Miller A3, Gallo S5, Arab L6.
Abstract
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.
KEYWORDS:
Clinical trial; Diet; Fatigue; Mediterranean; Multiple sclerosis