Diet showdown: could paleo or keto diets ease MS symptoms?
NCT ID NCT05007483
First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This study tests whether two special diets—a modified Paleolithic elimination diet and a time-restricted ketogenic diet—can improve quality of life, fatigue, and mood in 162 people with relapsing-remitting multiple sclerosis. Participants are assigned to one of the diets or standard dietary guidelines, and also take supplements like fish oil. The goal is to see if changing what you eat can make a real difference in how you feel day-to-day.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Modified Paleolithic Elimination diet and Time Restricted Olive Oil based Ketogenic diet, plus dietary supplements (fish oil, linoleic acid, phosphatidylcholine)
- What this could lead to
- If successful, this could show that dietary changes help manage MS symptoms like fatigue and mental health, offering a non-drug option to improve daily life.
- What could go wrong
- This is a mid-sized trial without a placebo control, and diet studies are hard to blind. Results may not apply to all MS patients, and benefits could be modest.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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162 people
The number who actually took part.
- Started
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Feb 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Eligibility for the run-in phase of the study: Participants will be eligible to enroll in the fourteen-day run-in phase of the study if they meet the following inclusion and exclusion criteria: INCLUSION CRITERIA: * A definitive diagnosis of RRMS based on the 2017 revised McDonald Criteria. * The ability to prepare, or availability of someone to prepare, home-cooked meals. * Must own a computer, smartphone, or tablet device that has internet access to complete online surveys and capable of running study related applications. * Must be willing to follow study procedures outlined and explained to them. * Be between the ages of 18 to 70 at the time of consent. * Must be able to walk 25 feet without support. * Willingness to be randomized and follow any of the study diets. * Must consent to sharing the clinical notes from their primary care and neurology providers during the study period. EXCLUSION CRITERIA: * Moderate or severe mental impairment. * Use of insulin, Coumadin, weight loss medications such as orlistat that causes fat malabsorption. * Worsening of symptoms resulting in the initiation or change of treatment including steroids (solumedrol, prednisone, etc.) or disease-modifying medications in 4 weeks prior to consent. * Treatment for cancer by radiation or chemotherapy in 12 months prior to consent, other than skin cancer. * Diagnosis of clinically significant heart disease, liver disease, kidney disease, or history of oxalate kidney stones. * Diagnosis of type II diabetes that does not have approval from treating physicians to adopt any of the 3 study diets. * Clinical diagnosis of moderate to severe psychiatric disease that makes study adherence more difficult (e.g., schizophrenia, bi-polar disease, severe depression and/or anxiety). * An active eating disorder such as anorexia, bulimia, binge eating, or orthorexia. * Measurement of BMI \<20. * Confirmation of pregnancy or planning to become pregnant in the next 2 years. * History of diagnosed fat intolerance/malabsorption such as cholecystectomy or uncontrolled exocrine pancreatic insufficiency. * Participation in another research study investigating MS treatments, diet, or exercise. * Presence of a contraindication to completing a brain MRI or having claustrophobia which interferes with completion of MRI studies without the use of sedation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Univeristy of Iowa
Iowa City, Iowa, 52246, United States
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