Randomized Controlled Trial of MIND Diet for Neuroprotection and Symptom Management in MS

RecruitingNot a drug-phase studyMS (type not specified)NCT06992115

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet

Given to everyone in the trial

  • Small Group

What it measured

Main measures

  • Changes in plasma neurofilament light chain (NfL)

    Baseline, 6-months, and at 12-months

    Blood or spinal fluid markers

Other measures (21)

  • Neurological Fatigue Index-MS (NFI-MS)

    Baseline, 6-months, and at 12-months

    Thinking and memoryFatigueMood and sleep
  • The Expanded Disability Status Scale (EDSS)

    Baseline, 6-months, and at 12-months

    Disability progression
  • The Symbol-Digit Modalities Test (SDMT)

    Baseline, 6-months, and at 12-months

    Thinking and memory
  • California Verbal Learning Test (CVLT-II)

    Baseline, 6-months, and at 12-months

    Thinking and memory
  • Brief Visuospatial Memory Test (BVMT-R)

    Baseline, 6-months, and at 12-months

    Thinking and memory
  • The 9-Hole Peg Test (9HPT)

    Baseline, 6-months, and at 12-months

    Disability progressionArm and hand function
  • Timed 25-Foot Walk (T25FW)

    Baseline, 6-months, and at 12-months

    Disability progressionWalking and mobility
  • The 2-Minute Walk Test

    Baseline, 6-months, and at 12-months

    Walking and mobility
  • Multiple Sclerosis Impact Scale (MSIS-29)

    Baseline, 6-months, and at 12-months

    Quality of life (reported by participants)
  • Multiple Sclerosis Cognitive Scale (MSCS)

    Baseline, 6-months, and at 12-months

    Thinking and memoryQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 70

Show the full criteria

Inclusion criteria

* Ages 18-70 years, inclusive * MS diagnosis, on any treatment (including no treatment) * MIND diet score of ≤9 at baseline

Exclusion criteria

* Diagnosis of an additional neurodegenerative disease (e.g. Alzheimer's) or other serious neurological condition (e.g. stroke) * Current serious medical condition that could impact the ability to participate or influence study results (e.g. cancer, HIV) * Pregnancy/planning during study period

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

Contact details on the registry

About this trial

In the sponsor's words

This study will assess the impact of a MIND (Mediterranean-DASH Intervention for Neurodegenerative Delay) diet on brain health and MS symptoms. Participants will be randomly assigned to one of two arms: the diet intervention arm or the "continue current diet"/control arm. Participants randomized to the dietary intervention arm will change their diet to follow a MIND dietary pattern for one year; diet-related education and programming is provided to support this change. Participants randomized to the continue/control arm will be asked to continue their current dietary habits, without major change for one year; multiple sclerosis (MS) MS-related related education and programming (unrelated to diet) is provided. All participants will be asked to provide blood \& stool samples and to complete online questionnaires \& three in-person assessments.

Papers

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    History

      1. Started

        Jul 2025

      2. Main results due

        Apr 2029

      3. Finished

        Apr 2029

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