NCT05007483Active, not recruiting
Efficacy of Diet on Quality of Life in Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
The overarching goal of this project is to critically evaluate the efficacy of incorporating dietary guidance within multiple sclerosis (MS) care for improving long-term quality of life (QoL) compared to usual care. The primary objective of this study is to evaluate the effect of two dietary interventions (time restricted olive oil based (TROO) ketogenic and modified Paleolithic elimination) on MS QoL compared to usual care control (Dietary Guidelines for America), and the secondary objectives and the long-term effects on, motor function, low-contrast vision sensitivity, fatigue, mood, and disease activity assessed by brain imaging.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 162 (actual)
- First submitted
- 9 Aug 2021
- Start date
- 10 Feb 2022
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Terry L. Wahls
- Diseases
- Multiple sclerosis
- NCT number
- NCT05007483
What you commit to
- Study type: Interventional
- Participants enrolled: 162
- From 10 Feb 2022 to the primary completion date, 1 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Moderate or severe mental impairment.
- 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.
- History of diagnosed fat intolerance/malabsorption such as cholecystectomy or uncontrolled exocrine pancreatic insufficiency.
Other
- Measurement of BMI \<20.
- Confirmation of pregnancy or planning to become pregnant in the next 2 years.
- 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.
Who the study is looking for
- 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.
Criteria the registry did not label
- 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:
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Univeristy of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.