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

CompletedNot a drug-phase studyRelapsing MSNCT02687919

What it found

Results posted, not judged

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

GroupValueIntervalNumber analysed
Modified Paleo Diet Intervention (MPDI)4.20 units on a scale0.6 (Standard Error)8
Usual Care3.99 units on a scale0.43 (Standard Error)9
Modified Paleo Diet Intervention (MPDI)2.82 units on a scale0.51 (Standard Error)8
Usual Care4.25 units on a scale0.43 (Standard Error)9

Modified Paleo Diet Intervention (MPDI)

4.2

Usual Care

3.99

Modified Paleo Diet Intervention (MPDI)

2.82

Usual Care

4.25

Change in Paced Auditory Serial Addition Test (PASAT) Score

End of Study, measured at 3.5 months; Change from Baseline

GroupValueIntervalNumber analysed
Modified Paleo Diet Intervention (MPDI)44.88 units on a scale1.71 (Standard Error)8
Usual Care53.22 units on a scale1.78 (Standard Error)9
Modified Paleo Diet Intervention (MPDI)49.75 units on a scale2.66 (Standard Error)8
Usual Care54.89 units on a scale1.3 (Standard Error)9

Modified Paleo Diet Intervention (MPDI)

44.88

Usual Care

53.22

Modified Paleo Diet Intervention (MPDI)

49.75

Usual Care

54.89

Change in 6-minute Walk (6-MW) Distance

End of Study, 3.5 months; Change from Baseline

GroupValueIntervalNumber analysed
Modified Paleo Diet Intervention (MPDI)570.11 meters21.15 (Standard Error)8
Usual Care532.95 meters19.85 (Standard Error)9
Modified Paleo Diet Intervention (MPDI)631.14 meters12.3 (Standard Error)8
Usual Care562.47 meters29.53 (Standard Error)9

Modified Paleo Diet Intervention (MPDI)

570.11

Usual Care

532.95

Modified Paleo Diet Intervention (MPDI)

631.14

Usual Care

562.47

Change in (25-FW) 25-ft Walk Time

End of Study, measured at 3.5 months; Change from Baseline

GroupValueIntervalNumber analysed
Modified Paleo Diet Intervention (MPDI)4.67 Seconds0.27 (Standard Error)8
Usual Care4.65 Seconds0.18 (Standard Error)9
Modified Paleo Diet Intervention (MPDI)4.13 Seconds0.2 (Standard Error)8
Usual Care4.51 Seconds0.2 (Standard Error)9

Modified Paleo Diet Intervention (MPDI)

4.67

Usual Care

4.65

Modified Paleo Diet Intervention (MPDI)

4.13

Usual Care

4.51

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Modified Paleo Diet Intervention (MPDI)90 (0.0%)0
Usual Care80 (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 inflammationFatigue
  • Change in Paced Auditory Serial Addition Test (PASAT) Score

    End of Study, measured at 3.5 months; Change from Baseline

    Thinking and memoryFatigue
  • Change in 6-minute Walk (6-MW) Distance

    End of Study, 3.5 months; Change from Baseline

    FatigueWalking and mobility
  • Change 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

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    History

      1. Started

        Oct 2012

      2. Main results due

        Sept 2014

      3. Finished

        Oct 2014

      4. Results posted

        Aug 2019

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