Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis

Initial visit/baseline measures for intervention and control groups (1-2 hrs): Subject Info and Demographics, Fatigue Severity Scale (FSS), Blood draw (vitamin B-1 (thiamine), vitamin B-9 (folate), vitamin B-12 (cobalamin), vitamin K, homocysteine, C-reactive protein), MS Functional Composite (MSFC) \[Timed 25-Foot Walk (T25-FW), 9-Hole Peg Test (9-HPT), Paced Auditory Serial Addition Test (PASAT)\], 6-minute walk, and Paced Visual Serial Addition Test (PVSAT). Complete at home/office/other: Automated Self-Administered 24-hour recall application (ASA24). Two-week run-in for intervention and control groups: Return survey instruments: \[Multiple Sclerosis Quality of Life-54 (MSQOL-54), Veterans Specific Activity Questionnaire (VSAQ), Medication, Vitamin, and Supplement Log, and Food Diary\]. Randomization; training for intervention and control groups (1-2 hrs). Training for the intervention group will involve orientation of subjects to the modified paleo diet and food logging; control group training will consist of study expectations (maintenance of normal diet) and food logging. Both will be conducted by a research team member, with subjects, on an individual basis. Begin 3-month study: 1 short follow-up call per week, for first three weeks, then every other week thereafter asking intervention and control group subjects if they need assistance with study procedures and providing assistance when needed/possible and ensuring subjects are accurately maintaining daily food log/diary (5 mins; could be longer/shorter depending on subject needs). If a subject (intervention or control arm) is having difficulty filling out the Food Log/Food Diary, he/she will have the opportunity to meet with research team members at a location of the subject's choosing (to include web-conferencing) for supplemental instruction. At 1 month and few days before returning for the final visit, complete at home/office/other: Automated Self-Administered 24-hour recall application (ASA24). Final visit\* for intervention and control groups (1-2 hrs): Multiple Sclerosis Quality of Life-54 (MSQOL-54), Fatigue Severity Scale (FSS), Veterans Specific Activity Questionnaire (VSAQ), Medication, Vitamin, and Supplement Log, Food Log, Blood draw (vitamin B-1 (thiamine), vitamin B-9 (folate), vitamin B-12 (cobalamin), vitamin K, homocysteine, C-reactive protein), MS Functional Composite (MSFC) \[Timed 25-Foot Walk (T25-FW), 9-Hole Peg Test (9-HPT), Paced Auditory Serial Addition Test (PASAT)\], 6-minute walk, and Paced Visual Serial Addition Test (PVSAT). \*End of participation for intervention group or cross-over (from control to 3-month intervention) for interested control group subjects. If regular in-person meetings are not possible (for two-week recall and/or supplemental instruction), a subject may choose to communicate with research staff via a web conferencing application (Google Hangout). The privacy policy may be found here: http://www.google.com/policies/privacy/ and will be provided to subjects upon request.