Mode
Text Size
Log in / Sign up
N/A N=31 Randomized Treatment

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

Multiple Sclerosis, Relapsing-remitting

Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Change in Fatigue Severity Scale (FSS)-9 Score — 4.20; 3.99; 2.82; 4.25 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Modified Paleo diet (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Amanda Irish
Primary completion
Sep 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Fatigue Severity Scale (FSS)-9 Score
4.20; 3.99; 2.82; 4.25
PRIMARY
Change in Paced Auditory Serial Addition Test (PASAT) Score
44.88; 53.22; 49.75; 54.89
PRIMARY
Change in 6-minute Walk (6-MW) Distance
570.11; 532.95; 631.14; 562.47
PRIMARY
Change in (25-FW) 25-ft Walk Time
4.67; 4.65; 4.13; 4.51
SECONDARY
Quality of Life (MSQOL-54)
67.26; 68.08; 74.47; 65.46; 81.77; 65.62
SECONDARY
Quality of Life (Vitamin B-1 Blood Serum Measures)
150.75; 129.50; 146.13; 127.11
SECONDARY
Quality of Life (Vitamin B-9 Blood Serum Measures)
15.68; 17.51; 15.61; 17.43
SECONDARY
Quality of Life (Vitamins B-12 and K Blood Serum Measures)
663.14; 497.96; 1643.38; 1758.25; 638.93; 500.21
SECONDARY
Quality of Life (Homocysteine Blood Serum Measures)
9.37; 9.27; 9.66; 10.01
SECONDARY
Quality of Life (C-reactive Protein Blood Serum Measures)
4.35; 1.40; 3.26; 1.93
SECONDARY
Quality of Life (9-HPT)
20.98; 19.61; 24.36; 20.41; 17.81; 19.02
SECONDARY
Quality of Life (VSAQ)
6.13; 5.78; 7.75; 5.78

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.

Eligibility Criteria

Inclusion Criteria

  • Verified diagnosis of relapsing-remitting multiple sclerosis (RRMS) with no change in medications in the prior three months.
  • Able to ambulate a minimum of 25 feet with/without use of an assistive device.

Exclusion Criteria

  • Under the age of 18 or over the age of 45 at the beginning of the study.
  • Unstable MS, requiring a change in medication in the prior 3 months.
  • Unwillingness to contact, or allow research to contact, neurologist for verification of RRMS diagnosis.
  • Psychosis or other psychiatric disorder likely to impact ability to comply with study procedures.
  • Change in prescriptions medication in the prior three months for a mental health problem such as depression or anxiety.
  • Active malignancy undergoing treatment (not including non melanoma skin cancers).
  • 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.
  • Abnormal bleeding disorder.
  • On any "diet" recommended to treat MS (ex: Best Bet, Swank, McDougall, MS Recovery diet, Wahls', other Paleolithic, gluten-free, vegetarian, and/or vegan
  • Inability to maintain food log for for seven consecutive days during the run-in phase of the study.
  • Not comfortable using a computer.
  • Other failure to demonstrate compliance.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02687919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search