Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Modified Paleo diet
Intervention type(s): Other
Intervention description(s): Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)
Other intervention name(s): Modified Paleolithic Diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diet (gluten-free); diet therapy; quality of life