NCT06992115 A Study of the MIND Diet for Persons With Multiple Sclerosis
| NCT ID | NCT06992115 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-05-12 |
| Primary Completion | 2029-04-30 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Ages 18-70 years, inclusive * MS diagnosis, on any treatment (including no treatment) * MIND diet score of ≤8 at baseline * NfL parameters determined by age 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
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