A Study of the MIND Diet for Persons With Multiple Sclerosis
Part of paid clinical trials in New York, New York.
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Study ID
- NCT06992115
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet — BEHAVIORALA dietary pattern which promotes the intake of olive oil, fish, leafy greens \& other vegetables, fruits, whole grains, and legumes, and discourages processed foods, red meat, and sugar.
- Small Group — BEHAVIORALEducation and social support on topics related to multiple sclerosis such as disease-modifying therapies and MRI in MS.
Study Details
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.
Key Dates
- Start date
- May 12, 2025
- Status verified
- Oct 2025
- Primary completion
- Apr 30, 2029
- Completion
- Apr 30, 2029
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: MIND DietParticipants randomized to the intervention arm will change their dietary patterns to adhere to the MIND diet for one year after randomization.
- Placebo Comparator: Continue DietParticipants randomized to the control arm will continue their current dietary habits, without major changes, for one year after randomization. Participants will not receive diet education in small group.
Primary Outcome Measure
Changes in plasma neurofilament light chain (NfL) [ Time Frame: Baseline, 6-months, and at 12-months ]
Central Contacts
- Claire E Wigley, Bsc, BSPH(212) 241-3759
- Susan Filomena212-241-3841
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | Ilana B Katz Sand (PRINCIPAL_INVESTIGATOR) |
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