Effects of a Low Fat Plant Based Diet in Multiple Sclerosis (MS): Results of a 1- Year Long Randomized Controlled (RC) Study (P6.152)

Abstract

OBJECTIVE: To determine the compliance and safety of a plant-based low-fat diet and obtain preliminary data on its effects on brain magnetic resonance imaging (MRI), clinical outcomes, lipids, insulin and body weight in relapsing remitting MS patients. BACKGROUND: Emerging evidence suggests diet and vascular risk factors including obesity and hyperlipidemia may influence MS disease progression. DESIGN/METHODS: A prospective, RC, rater-blinded 1-year study with subjects assigned to a low-fat diet (diet) or wait-listed (control) group. Study outcomes: changes over one year in: brain MRI new T2 lesion count and other MRI disease activity and atrophy parameters; safety, changes in: relapse rate, disability [expanded disability status score (EDSS)], Timed 25-foot walk (T25W), Fatigue Severity Score (FSS), blood lipids, body weight and compliance. RESULTS: 61 subjects [diet -32 (including 6 drop outs); control - 29 (including 2 drop outs)]; median age 41 (range 24-55) y, mean disease duration 5.3 (range 0.8-14.7) y, mean EDSS 2.5 (range 0-4.5) were randomized. After baseline difference adjustment, the groups showed no significant changes in the number of active lesions (0.4, 95% CI -1.2 to1.9, p=0.6) or other MR parameters, relapse rate, EDSS, T25W and FSS. Mean (SD) change in Low Density Lipoprotein (LDL) and Total Cholesterol (TC)(mg/dL): Diet compliant (22/26) : -12.4 (22.4) and -16.2(28.5) vs. Control: -5.6 (24.8), -4.7 (28.5); Weight change (lbs) [mean (SD, range)]: Diet compliant (22/26): -16.3 (17.4, +6.8 - -52.1) vs. Control: +1.6 (12, +28.2 - -32.9). Results of fasting glucose, insulin and novel lipid markers will be presented. CONCLUSIONS: This study demonstrated safety and achievable compliance of this diet. Small sample size, use of disease modifying therapies by many subjects, and one-year follow up likely contributed to the reduced power to detect changes on MRI and clinical outcomes. Improved lipid profile and weight may yield longer term vascular health benefits. Longer future studies with larger sample size are needed. Support: McDougall Research & Education Foundation, OHSU Foundation, Department of Veterans Affairs.

Disclosure: Dr. Yadav has received personal compensation for activities with Bayer, Teva Neuroscience, and Novartis. Dr. Yadav has received research support from Biogen Idec. Dr. Marracci has received royalty payments. Dr. Kim has received personal compensation for activities with Biogen Idec as a speaker. Dr. Spain has nothing to disclose. Dr. Cameron has received personal compensation for activities with Acorda Therapeutics, and the MS Association of America. Dr. Cameron has received research support from Acorda Therapeutics, and the VA Rehabilitation Research Development Service. Dr. Overs has received personal compensation for activities with Biogen Idec. Dr. McDougall has received personal compensation for activities with the McDougall Health & Medical Center. Dr. McDougall holds stock and/or stock options in the McDougall Health & Medical Center. Dr. Lovera has received personal compensation for activities with EMD Serono, Teva Neuroscience, and Biogen Idec as a consultant. Dr. Bourdette has received personal compensation for activities with Biogen Idec, Serono Inc., and Teva Neuroscience.