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Diet showdown: could paleo or keto diets ease MS symptoms?

NCT ID NCT05007483

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

162 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Univeristy of Iowa

    Iowa City, Iowa, 52246, United States

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Other studies related to the condition(s) this trial covers.