Can diet ease the crushing fatigue of multiple sclerosis?
NCT ID NCT02914964
First seen Sep 18, 2026 ยท Last updated Sep 18, 2026
Summary
Researchers are comparing two diets to see whether either one reduces fatigue in people with relapsing-remitting multiple sclerosis. Participants follow their usual diet for 12 weeks, then are randomly assigned to the Swank low-saturated-fat diet or the Wahls Elimination modified paleo diet for 24 weeks. A dietitian counsels participants by phone and in person to help them stick with their assigned diet. The study measures changes in fatigue severity and how much fatigue interferes with daily life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dietary counseling for the Swank low-saturated-fat diet or the Wahls Elimination modified paleo diet
- What this could lead to
- If one diet helps, it could give people with multiple sclerosis a low-cost, drug-free way to manage fatigue. It could also point researchers toward which foods matter most for energy levels.
- What could go wrong
- Diet studies are hard to run because people know which diet they follow and may not stick with it. Any improvement could come from eating better overall rather than from one specific diet, and the results may not apply to everyone with MS.
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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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95 people
The number who actually took part.
- Started
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Aug 2016
- Finished
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Feb 2025
- 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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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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.
Inclusion Criteria: * Willing to allow your neurologist to sign a letter confirming multiple sclerosis diagnosis and criteria used in diagnosis * Relapsing-Remitting Multiple Sclerosis as documented by the McDonald Criteria confirmed by their treating neurologist * Fatigue as documented by a Fatigue Severity Scale score of greater than or equal to 4 * Between the ages of 18 and 70 * Body Mass Index greater than or equal to 19 * Ability to shop for and prepare or have someone in the family shop for and prepare home cooked meals according to study diet guidelines * Willingness to keep detailed food records * Willing to eat a diet that includes more vegetables and excludes many comfort foods such as those made with white flour, * Willing to eat a diet that eliminates red meat (beef, pork, lamb, veal) and saturated fats (butter, coconut oil, margarine, hydrogenated oils found in processed foods) to 1 tablespoon per day * Must not be pregnant or planning to become pregnant in the next year * Willing to eat meat (eg, chicken, turkey, fish) * Willingness to follow either the Wahls Elimination diet or the Swank diet * Individuals who have had gastric bypass surgery have obtained a signed statement from their physician indicating they are weight stable and a suitable candidate for this study * Normal or mild cognitive impairment as measured by the Short Portable Mental Status Questionnaire * Willing to have blood drawn * Be able to walk 25 feet without support, or with only unilateral support (i.e. cane in one hand) Exclusion Criteria: * Taking insulin or Coumadin * Relapse within past 12 weeks * Treatment for a cancer (other than skin cancer) currently or in the prior 12 months * Diagnosis of heart failure, liver cirrhosis, angina, history of kidney stones, psychiatric disease likely to make adherence to the study interventions more difficult including eating disorders, but excluding depression and anxiety * Body Mass Index less than 19 * Moderate to severe mental impairment as measured by the Short Portable Mental Status questionnaire * Inability to shop for and prepare home cooked meals by the subject or a companion * Unwillingness to eat meat * Participation in another research study that involves multiple sclerosis or other medications, diet, supplement, exercise or other treatments * Inability to keep food records with sufficient detail to asses dietary intake or complete study questionnaires * Unwilling to have blood drawn * Pregnant or planning to become pregnant in the next year
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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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University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
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