A Study of the MIND Diet for Persons With Multiple Sclerosis
NCT ID: NCT06992115
Last Updated: 2025-10-14
Study Results
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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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-05-12
2029-04-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
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.
Small Group
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.
Small Group
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.
Small Group
Education and social support on topics related to multiple sclerosis such as disease-modifying therapies and MRI in MS.
Eligibility Criteria
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Inclusion Criteria
* MS diagnosis, on any treatment (including no treatment)
* MIND diet score of ≤8 at baseline
* NfL parameters determined by age
Exclusion Criteria
* Current serious medical condition that could impact the ability to participate or influence study results (e.g. cancer, HIV)
* Pregnancy/planning during study period
18 Years
70 Years
ALL
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Ilana Katz Sand
Associate Professor, Neurology; Associate Director, CGD Center for MS
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
Countries
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Central Contacts
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Facility Contacts
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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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