A Study of the MIND Diet for Persons With Multiple Sclerosis

NCT06992115 | Recruiting

• 2 other identifiers: GCO 23-0300RG-2407-43743
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Diet

Outcome Measures

Primary Outcomes (1)

• Changes in plasma neurofilament light chain (NfL)

  Plasma NfL quantification will be reported in units of pg/ml.

  Baseline, 6-months, and at 12-months

Secondary Outcomes (21)

• Neurological Fatigue Index-MS (NFI-MS)

  Baseline, 6-months, and at 12-months

• The Expanded Disability Status Scale (EDSS)

  Baseline, 6-months, and at 12-months

• The Symbol-Digit Modalities Test (SDMT)

  Baseline, 6-months, and at 12-months

• California Verbal Learning Test (CVLT-II)

  Baseline, 6-months, and at 12-months

• Brief Visuospatial Memory Test (BVMT-R)

  Baseline, 6-months, and at 12-months

Study Arms (2)

MIND Diet

EXPERIMENTAL

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

Behavioral: Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet; Behavioral: Small Group

Continue Diet

PLACEBO COMPARATOR

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.

Behavioral: Small Group

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.

MIND Diet

Small Group BEHAVIORAL

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

Continue Diet; MIND Diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Diet

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Ilana B Katz Sand, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire E Wigley, Bsc, BSPH

CONTACT

(212) 241-3759; claire.wigley@mssm.edu

Susan Filomena

CONTACT

212-241-3841; susan.filomena@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Neurological exams and functional \& cognitive assessments will be conducted by trained staff who are masked from the participant's diet assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Neurology; Associate Director, CGD Center for MS

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 28, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)