A Modified Mediterranean Dietary Intervention for Multiple Sclerosis: Results of a Pilot Study (P4.2-066)

Objective: To assess clinical trial feasibility and explore effects of a modified Mediterranean dietary intervention in MS Background: Interest in the role of diet among MS patients is quite high. At the same time, there is increasing scientific evidence for the importance of dietary factors in MS incidence and disease course. Based on available literature, we developed a rationally-designed dietary intervention (restrictive, modified Mediterranean diet) and conducted a randomized pilot study in women with MS for 6 months. Design/Methods: Participants were randomly assigned to the modified Mediterranean dietary intervention or control arm (educational seminars). The intervention group received training with the study nutritionist and attended monthly meetings to assess and promote adherence. Formal assessments were completed at baseline and 6 months. Results: We screened 131 patients between December 2016 and October 2017. Of these, 36 (27.5%) were eligible and willing to commit to the study. 18/18 assigned to the intervention group and 16/18 assigned to the non-intervention group completed the study. Self-reported adherence was excellent (mean at 6 months= 90.3%). Additional adherence data utilizing other measures will be reported. 16/18 participants reported some benefit to their overall health and 14/18 reported specific benefits regarding MS symptoms. Mean change on the Neurological Fatigue Index-MS was −2.3±5.3 compared to +2.0±3.1 for controls (p=0.006) and mean change on Multiple Sclerosis Impact Scale-29 after exclusion of one outlier was −5.0±9.3 vs +4.4±11.1 (p=0.01). Conclusions: It is feasible to enroll MS patients into a rigorous dietary intervention study requiring significant commitment and randomization and reasonable to expect high adherence to this type of dietary program utilizing educational methods to promote adherence. Preliminarily, this regimen improves fatigue and decreases the impact of MS symptoms. Larger scale clinical trials to assess the role of diet for symptom management and even as a disease-modifier in MS are feasible and warranted. Disclosure: Dr. Katz Sand has nothing to disclose. Dr. Digga has nothing to disclose. Dr. Benn has nothing to disclose. Dr. Desphande has nothing to disclose. Dr. Gallo has nothing to disclose. Dr. Fabian has nothing to disclose. Dr. Miller has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Accordant Health Services (Caremark), Adamas, BiogenIdec, Celgene, Corrona, EMD Serono, Genzyme/Sanofi, Mallinckrodt, Mapi-Pharma, Novartis, and Roche/Genentech. Dr. Miller has received personal compensation in an editorial capacity for Continuum Audio. Dr. Miller has received research support from BiogenIdec, Genzyme/Sanofi, Mallickrodt, Novartis, Roche/Genentech, and MedDay. Dr. Arab has nothing to disclose.