Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 10/14/2017 |
| Start Date: | October 2012 |
| End Date: | October 2014 |
Randomized Control Trial Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis: A Pilot Study
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.
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.
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.
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