A Study of the MIND Diet for Persons With Multiple Sclerosis

NCT ID: NCT06992115

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2029-04-30

Brief Summary

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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.

Detailed Description

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The goal of this study is to evaluate the effects of a Mediterranean-style dietary intervention on neuroprotection and symptom management in MS with an early phase II, randomized, controlled clinical trial. Participants will be randomized-stratified by MS phenotype and treatment type-to the diet intervention arm (change current diet to a MIND diet) or the continue/control arm (no major change in current dietary habits).

All patients will participate in a baseline visit, and 6 month visit, a 12 month (end of study visit), and meet with small support groups between study visits.

Participants will also complete online questionnaires, undergo functional \& cognitive assessments, and contribute blood \& stool samples while on protocol.

The diet intervention arm will receive MIND diet-related education and support from the study dietitian and the principal investigator; virtual small group environments will facilitate discussion about participants' experience and potential challenges with MIND diet adherence and ways to overcome them. Virtual groups will meet weekly for the first month, then monthly through month 12.

The continue current dietary habits /control arm will receive MS-related education and support unrelated to diet from members of the study team and the principal investigator. Group meeting topics and schedules will be provided in advance to offer flexibility; participants are required to attend 6 virtual small group meetings but are invited to join as many as desired.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Neurological exams and functional \& cognitive assessments will be conducted by trained staff who are masked from the participant's diet assignment.

Study Groups

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MIND Diet

Participants randomized to the intervention arm will change their dietary patterns to adhere to the MIND diet for one year after randomization.

Group Type EXPERIMENTAL

Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet

Intervention Type 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

Intervention Type BEHAVIORAL

Education and social support on topics related to multiple sclerosis such as disease-modifying therapies and MRI in MS.

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.

Group Type PLACEBO_COMPARATOR

Small Group

Intervention Type BEHAVIORAL

Education and social support on topics related to multiple sclerosis such as disease-modifying therapies and MRI in MS.

Interventions

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Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet

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.

Intervention Type BEHAVIORAL

Small Group

Education and social support on topics related to multiple sclerosis such as disease-modifying therapies and MRI in MS.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Ilana Katz Sand

Associate Professor, Neurology; Associate Director, CGD Center for MS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ilana B Katz Sand, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai Hospital

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Claire E Wigley, Bsc, BSPH

Role: CONTACT

(212) 241-3759

Susan Filomena

Role: CONTACT

212-241-3841 ext. 43841

Facility Contacts

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Ilana B Katz Sand, MD

Role: primary

212-241-6854

Other Identifiers

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RG-2407-43743

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GCO 23-0300

Identifier Type: -

Identifier Source: org_study_id

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