Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis
Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis
This is a research study. The investigators are inviting participants to participate in this
 research study between the ages of 18-45, who have stable Relapsing-Remitting Multiple
 Sclerosis (RRMS), are able to walk 25 ft with/without an assistive device, and have none of
 the following: liver disease, kidney disease, diabetes, active heart disease, heart block or
 arrhythmias, bleeding disorders, concurrent diuretic use, anti-coagulation or anti-platelet
 use, psychosis or other psychiatric disorder likely to impact ability to comply with study
 procedures, any change in prescription medication for a mental health problem such as
 depression or anxiety in the last three months.

 The purpose of this research study is to determine whether or not a modified Paleolithic diet
 results in any change in health in persons with RRMS compared to usual care. The
 investigators define usual care as the typical or usual physician recommendations for the
 treatment of RRMS.

 The Paleolithic diet (or Paleo diet), also referred to as the caveman diet, Stone Age diet,
 and hunter-gatherer diet, is a modern nutritional plan based on the presumed ancient diet of
 wild plants and animals of ancestral humans during the Paleolithic era (a period of about 2.5
 million years duration that ended around 10,000 years ago with the development of
 agriculture). The diet consists mainly of fish, grass-fed pasture raised meats, vegetables,
 fruit, fungi, roots, and nuts, and excludes grains, legumes, dairy products, salt, refined
 sugar, and processed oils.

 To the investigators' knowledge, most neurologists prescribe medications that may reduce or
 prevent future disability, but few prescribe dietary modifications unless needed for other
 concomitant disease.
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.
Inclusion Criteria:

 1. Verified diagnosis of relapsing-remitting multiple sclerosis (RRMS) with no change in
 medications in the prior three months.

 2. Able to ambulate a minimum of 25 feet with/without use of an assistive device.

 Exclusion Criteria:

 1. Under the age of 18 or over the age of 45 at the beginning of the study.

 2. Unstable MS, requiring a change in medication in the prior 3 months.

 3. Unwillingness to contact, or allow research to contact, neurologist for verification
 of RRMS diagnosis.

 4. Psychosis or other psychiatric disorder likely to impact ability to comply with study
 procedures.

 5. Change in prescriptions medication in the prior three months for a mental health
 problem such as depression or anxiety.

 6. Active malignancy undergoing treatment (not including non melanoma skin cancers).

 7. Subjects with liver disease, kidney disease, diabetes, active heart disease, heart
 block or arrhythmias, bleeding disorders, concurrent diuretic use, anti-coagulation or
 anti-platelet use.

 8. Abnormal bleeding disorder.

 9. On any "diet" recommended to treat MS (ex: Best Bet, Swank, McDougall, MS Recovery
 diet, Wahls', other Paleolithic, gluten-free, vegetarian, and/or vegan

 10. Inability to maintain food log for for seven consecutive days during the run-in phase
 of the study.

 11. Not comfortable using a computer.

 12. Other failure to demonstrate compliance.