Evaluation of a Modified Paleolithic Dietary Intervention in the Treat
Randomized Control Trial Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis: A Pilot Study
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Modified Paleo diet
Results by group
Change in Fatigue Severity Scale (FSS)-9 Score
End of Study, measured at 3.5 months; Change from Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Modified Paleo Diet Intervention (MPDI) | 4.20 units on a scale | 0.6 (Standard Error) | 8 |
| Usual Care | 3.99 units on a scale | 0.43 (Standard Error) | 9 |
| Modified Paleo Diet Intervention (MPDI) | 2.82 units on a scale | 0.51 (Standard Error) | 8 |
| Usual Care | 4.25 units on a scale | 0.43 (Standard Error) | 9 |
Modified Paleo Diet Intervention (MPDI)
Usual Care
Modified Paleo Diet Intervention (MPDI)
Usual Care
Change in Paced Auditory Serial Addition Test (PASAT) Score
End of Study, measured at 3.5 months; Change from Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Modified Paleo Diet Intervention (MPDI) | 44.88 units on a scale | 1.71 (Standard Error) | 8 |
| Usual Care | 53.22 units on a scale | 1.78 (Standard Error) | 9 |
| Modified Paleo Diet Intervention (MPDI) | 49.75 units on a scale | 2.66 (Standard Error) | 8 |
| Usual Care | 54.89 units on a scale | 1.3 (Standard Error) | 9 |
Modified Paleo Diet Intervention (MPDI)
Usual Care
Modified Paleo Diet Intervention (MPDI)
Usual Care
Change in 6-minute Walk (6-MW) Distance
End of Study, 3.5 months; Change from Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Modified Paleo Diet Intervention (MPDI) | 570.11 meters | 21.15 (Standard Error) | 8 |
| Usual Care | 532.95 meters | 19.85 (Standard Error) | 9 |
| Modified Paleo Diet Intervention (MPDI) | 631.14 meters | 12.3 (Standard Error) | 8 |
| Usual Care | 562.47 meters | 29.53 (Standard Error) | 9 |
Modified Paleo Diet Intervention (MPDI)
Usual Care
Modified Paleo Diet Intervention (MPDI)
Usual Care
Change in (25-FW) 25-ft Walk Time
End of Study, measured at 3.5 months; Change from Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Modified Paleo Diet Intervention (MPDI) | 4.67 Seconds | 0.27 (Standard Error) | 8 |
| Usual Care | 4.65 Seconds | 0.18 (Standard Error) | 9 |
| Modified Paleo Diet Intervention (MPDI) | 4.13 Seconds | 0.2 (Standard Error) | 8 |
| Usual Care | 4.51 Seconds | 0.2 (Standard Error) | 9 |
Modified Paleo Diet Intervention (MPDI)
Usual Care
Modified Paleo Diet Intervention (MPDI)
Usual Care
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Modified Paleo Diet Intervention (MPDI) | 9 | 0 (0.0%) | 0 |
| Usual Care | 8 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change in Fatigue Severity Scale (FSS)-9 Score
End of Study, measured at 3.5 months; Change from Baseline
Smouldering inflammationFatigueChange in Paced Auditory Serial Addition Test (PASAT) Score
End of Study, measured at 3.5 months; Change from Baseline
Thinking and memoryFatigueChange in 6-minute Walk (6-MW) Distance
End of Study, 3.5 months; Change from Baseline
FatigueWalking and mobilityChange in (25-FW) 25-ft Walk Time
End of Study, measured at 3.5 months; Change from Baseline
Disability progressionFatigueWalking and mobility
Other measures (8)
Quality of Life (MSQOL-54)
End of Study, measured at 3.5 months; Change from Baseline
Quality of life (reported by participants)Quality of Life (Vitamin B-1 Blood Serum Measures)
End of Study, measured at 3.5 months; Change from Baseline
Quality of life (reported by participants)Quality of Life (Vitamin B-9 Blood Serum Measures)
End of Study, measured at 3.5 months; Change from Baseline
Quality of life (reported by participants)Quality of Life (Vitamins B-12 and K Blood Serum Measures)
End of Study, measured at 3.5 months; Change from Baseline
Quality of life (reported by participants)Quality of Life (Homocysteine Blood Serum Measures)
End of Study, measured at 3.5 months; Change from Baseline
Quality of life (reported by participants)Quality of Life (C-reactive Protein Blood Serum Measures)
End of Study, measured at 3.5 months; Change from Baseline
Quality of life (reported by participants)Quality of Life (9-HPT)
End of Study, measured at 3.5 months; Change from Baseline
Disability progressionArm and hand functionQuality of life (reported by participants)Quality of Life (VSAQ)
End of Study, measured at 3.5 months; Change from Baseline
Physical functionQuality of life (reported by participants)
Who could take part
Relapsing MS · 18 to 45
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Oct 2012
Main results due
Sept 2014
Finished
Oct 2014
Results posted
Aug 2019