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

Completed · Not applicable

Conditions studied: Multiple Sclerosis, Relapsing-remitting

In brief

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.

Key facts

Study ID: NCT02687919
Run by: Amanda Irish
People needed: 31
Starts: 2012-10-01
Expected to finish: 2014-10-01
Last updated by the study team: 2019-08-12

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Iowa — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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