Clinical trial NCT02687919: Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis
Official title: Randomized Control Trial Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-remitting
Keywords: diet (gluten-free)
diet therapy
quality of life
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Fatigue Severity Scale (FSS)-9 Score
timeFrame: End of Study, measured at 3.5 months; Change from Baseline
measure: Change in Paced Auditory Serial Addition Test (PASAT) Score
timeFrame: End of Study, measured at 3.5 months; Change from Baseline
measure: Change in 6-minute Walk (6-MW) Distance
timeFrame: End of Study, 3.5 months; Change from Baseline
measure: Change in (25-FW) 25-ft Walk Time
timeFrame: End of Study, measured at 3.5 months; Change from Baseline
Secondary outcomes:
measure: Quality of Life (MSQOL-54)
timeFrame: End of Study, measured at 3.5 months; Change from Baseline
measure: Quality of Life (Vitamin B-1 Blood Serum Measures)
timeFrame: End of Study, measured at 3.5 months; Change from Baseline
measure: Quality of Life (Vitamin B-9 Blood Serum Measures)
timeFrame: End of Study, measured at 3.5 months; Change from Baseline
measure: Quality of Life (Vitamins B-12 and K Blood Serum Measures)
timeFrame: End of Study, measured at 3.5 months; Change from Baseline
measure: Quality of Life (Homocysteine Blood Serum Measures)
timeFrame: End of Study, measured at 3.5 months; Change from Baseline
measure: Quality of Life (C-reactive Protein Blood Serum Measures)
timeFrame: End of Study, measured at 3.5 months; Change from Baseline
measure: Quality of Life (9-HPT)
timeFrame: End of Study, measured at 3.5 months; Change from Baseline
measure: Quality of Life (VSAQ)
timeFrame: End of Study, measured at 3.5 months; Change from Baseline
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Amanda K Irish
role: PRINCIPAL_INVESTIGATOR
References: