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 — BEHAVIORAL
    A 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 — BEHAVIORAL
    Education 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 Diet
    Participants randomized to the intervention arm will change their dietary patterns to adhere to the MIND diet for one year after randomization.
  • Placebo Comparator: Continue Diet
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalNew YorkNew York10029
Ilana B Katz Sand, MD
212-241-6854
Ilana B Katz Sand (PRINCIPAL_INVESTIGATOR)

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