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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Control Trial Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis: A Pilot Study

Brief 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 Summary:

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
Sponsor: University of Iowa

Current Primary Outcome:

  • Fatigue reduction (a) Daily life [ Time Frame: End of Study, measured at 3.5 months (6.5 months for cross-over subjects); Change from Baseline ]
    Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (a) daily life as measured by the Fatigue Severity Scale (FSS) score.
  • Fatigue reduction (b) Cognition [ Time Frame: End of Study, measured at 3.5 months (6.5 months for cross-over subjects); Change from Baseline ]
    Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (b) cognitive fatigue as measured by the Paced Auditory Serial Addition Test (PASAT) score.
  • Fatigue reduction (c) Physical (6-MW) [ Time Frame: End of Study, 3.5 months (6.5 months for cross-over subjects); Change from Baseline ]
    Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (c) physical fatigue as measured by the 6-minute (m) walk (6-MW).
  • Fatigue reduction (d) Physical (25-FW) [ Time Frame: End of Study, measured at 3.5 months (6.5 months for cross-over subjects); Change from Baseline ]
    Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to contro

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Quality of Life (MSQOL-54) [ Time Frame: End of Study, measured at 3.5 months (6.5 months for cross-over subjects); Change from Baseline ]
      Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by: Multiple Sclerosis Quality of Life-54 (MSQOL-54) scores.
    • Quality of Life (blood serum measures) [ Time Frame: End of Study, measured at 3.5 months (6.5 months for cross-over subjects); Change from Baseline ]
      Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by blood serum measures: vitamin B-1 (thiamine), vitamin B-9 (folate), vitamin B-12 (cobalamin), vitamin K, homocysteine, and C-reactive protein.
    • Quality of Life (9-HPT) [ Time Frame: End of Study, measured at 3.5 months (6.5 months for cross-over subjects); Change from Baseline ]
      Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by the 9-Hole Peg Test (9-HPT).
    • Quality of Life (VSAQ) [ Time Frame: End of Study, measured at 3.5 months (6.5 months for cross-over subjects); Change from Baseline ]
      Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by the Veterans Specific Activity Questionnaire (VSAQ).


    Original Secondary Outcome: Same as current

    Information By: University of Iowa

    Dates:
    Date Received: January 22, 2016
    Date Started: October 2012
    Date Completion:
    Last Updated: February 16, 2016
    Last Verified: February 2016