Running, not recruitingNot a drug-phase studyRelapsing MSNCT05007483

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Linoleic acid
  • Doconexent
  • Phosphatidylcholine
  • Modified Paleolithic Elimination diet
  • Time Restricted Olive Oil Based (TROO) Ketogenic Diet

Compared with

  • Usual diet with Dietary Guidelines for Americans Diet information

What it measured

Main measures

  • Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)

    baseline to 3 Months

    Quality of life (reported by participants)
  • Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)

    baseline to 6 Months

    Quality of life (reported by participants)
  • Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)

    baseline to 12 Months

    Quality of life (reported by participants)
  • Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)

    baseline to 18 Months

    Quality of life (reported by participants)
  • Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)

    baseline to 24 Months

    Quality of life (reported by participants)
  • Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)

    baseline to 3 Months

    Quality of life (reported by participants)
  • Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)

    baseline to 6 Months

    Quality of life (reported by participants)

Other measures (35)

  • Modified Fatigue Impact Scale (MFIS)

    baseline to 3 months

    Fatigue
  • Modified Fatigue Impact Scale (MFIS)

    baseline to 6 months

    Fatigue
  • Modified Fatigue Impact Scale (MFIS)

    baseline to 12 months

    Fatigue
  • Modified Fatigue Impact Scale (MFIS)

    baseline to 18 months

    Fatigue
  • Modified Fatigue Impact Scale (MFIS)

    baseline to 24 months

    Fatigue
  • Hospital Anxiety Depression Scale (HADS)

    baseline to 3 months

    Mood and sleep
  • Hospital Anxiety Depression Scale (HADS)

    baseline to 6 months

    Mood and sleep
  • Hospital Anxiety Depression Scale (HADS)

    baseline to 12 months

    Mood and sleep
  • Hospital Anxiety Depression Scale (HADS)

    baseline to 18 months

    Mood and sleep
  • Hospital Anxiety Depression Scale (HADS)

    baseline to 24 months

    Mood and sleep

Who could take part

Relapsing MS · 18 to 70

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      Feb 2022

    2. Main results due

      Oct 2026

    3. Finished

      Dec 2026

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