A Study of the MIND Diet for Persons With Multiple Sclerosis

October 9, 2025 updated by: Ilana Katz Sand, Icahn School of Medicine at Mount Sinai

Randomized Controlled Trial of MIND Diet for Neuroprotection and Symptom Management in MS

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
        • Principal Investigator:
          • Ilana B Katz Sand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
Behavioral: Small Group
Education and social support on topics related to multiple sclerosis such as disease-modifying therapies and MRI in MS.
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.
Behavioral: Small Group
Education and social support on topics related to multiple sclerosis such as disease-modifying therapies and MRI in MS.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in plasma neurofilament light chain (NfL)
Time Frame: Baseline, 6-months, and at 12-months
Plasma NfL quantification will be reported in units of pg/ml.
Baseline, 6-months, and at 12-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neurological Fatigue Index-MS (NFI-MS)
Time Frame: Baseline, 6-months, and at 12-months
The NFI-MS is a brief (5-10-minute completion time), 23-item survey that measures fatigue in MS. Each question corresponds to a subscale that describes different facets of MS fatigue: physical (range 0-8), cognitive (range 0-4), relief by diurnal sleep or rest (range 0-6), and abnormal nocturnal sleep & sleepiness (range 0-5). A summary score (range 0-30) can be calculated based on the responses from 10 of the items on the questionnaire. Scores are based on the respondent's level of agreement with each statement (0, Strongly Disagree; 1, Disagree; 2, Agree; 3, Strongly Agree); higher scores indicate higher levels of fatigue.
Baseline, 6-months, and at 12-months
The Symbol-Digit Modalities Test (SDMT)
Time Frame: Baseline, 6-months, and at 12-months
The Symbol Digit Modalities Test (SDMT) presents a series of nine symbols, each paired with a single digit in a key at the top of a stimulus page. Subjects voice the number associated with each symbol as rapidly as possible. The examiner records the total amount of responses completed. The task continues for 90 seconds with the research staff recording responses. The SDMT score ranges from 0 to 110, with higher values representing a better outcome in cognitive processing speed.
Baseline, 6-months, and at 12-months
California Verbal Learning Test (CVLT-II)
Time Frame: Baseline, 6-months, and at 12-months

The California Verbal Learning Test-Second Edition (CVLT-II) is a widely used neuropsychological assessment designed to evaluate verbal learning and memory. It requires individuals to recall words across multiple trials, measuring encoding, recall strategies, and recognition accuracy.

Scores are based on the number of correctly recalled words across different conditions, including immediate free recall, short-delay free & cued recall, long-delay free & cued recall. Each trial is scored separately, with higher scores (range 0-16) indicating the successful recall of a word; raw scores are converted to a T-score based on age-and-sex-matched normative data.
Baseline, 6-months, and at 12-months
Brief Visuospatial Memory Test (BVMT-R)
Time Frame: Baseline, 6-months, and at 12-months

The Brief Visuospatial Memory Test-Revised (BVMT-R) is a neuropsychological assessment designed to measure visuospatial learning and memory. It consists of multiple trials where individuals are asked to recall and recognize geometric figures after a brief exposure.

Scores are based on the number and accuracy of correctly recalled figures across trials. Each trial is scored separately, with higher scores (range 0-12) indicating the successful recall of a word; raw scores are converted to a T-score and percentile based on age-matched normative data.

Higher scores (range 0-9) indicating better visuospatial memory performance
Baseline, 6-months, and at 12-months
The 9-Hole Peg Test (9HPT)
Time Frame: Baseline, 6-months, and at 12-months
The 9-Hole Peg Test (9HPT) assesses finger dexterity and fine motor coordination. Participants place and remove pegs from a board as quickly as possible, with completion time serving as the primary measure, where faster times indicate better performance.
Baseline, 6-months, and at 12-months
Timed 25-Foot Walk (T25FW)
Time Frame: Baseline, 6-months, and at 12-months
Timed 25-Foot Walk (T25FW) evaluates walking speed and ability; a faster completion time on these tests indicates a better performance.
Baseline, 6-months, and at 12-months
The 2-Minute Walk Test
Time Frame: Baseline, 6-months, and at 12-months
The 2-Minute Walk Test measures endurance, indicated by a greater distance walked over a two-minute interval.
Baseline, 6-months, and at 12-months
Multiple Sclerosis Impact Scale (MSIS-29)
Time Frame: Baseline, 6-months, and at 12-months
The MSIS-29 is a 29-item questionnaire designed to assess the extent to which individuals feel their MS impacts their daily life. Respondents rate the effect of MS on different aspects of their life using a 5-point scale (1 = Not At All, 2 = A Little, 3 = Moderately, 4 = Quite A Bit, 5 = Extremely). The questionnaire includes two subscales: a physical subscale with 20 items and a psychological subscale with 9 items. The total range for each subscale is transformed to a 0-100 scale, with higher scores indicating a greater perceived negative impact of MS.
Baseline, 6-months, and at 12-months
Multiple Sclerosis Cognitive Scale (MSCS)
Time Frame: Baseline, 6-months, and at 12-months
The MSCS is an 8-item questionnaire designed to assess patient-reported cognitive deficits in individuals with MS. Each item is scored based on the frequency of cognitive difficulties experienced over the past month (0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often). The scale includes four 2-item subscales-Executive/Speed, Working Memory, Expressive Language, and Episodic Memory-each with a total range of 0-8. A total score (range 0-32) is calculated by summing all item scores, with higher scores indicating greater cognitive impairment due to MS.
Baseline, 6-months, and at 12-months
MIND Diet Score
Time Frame: Baseline, 6-months, and at 12-months
Adherence to MIND Diet will be measured using MIND Diet score, where scores range 0-14. Higher scores indicate better adherence to a Mediterranean-style (MIND) diet and points are assigned based on how often an individual consumes the food group in question.
Baseline, 6-months, and at 12-months
MIND Diet Adherence Score
Time Frame: Baseline, 6-months, and at 12-months
Those assigned to the diet intervention arm will complete a self-assessment of their adherence to the MIND diet, indicating how closely an individual believes they are following the MIND diet. Scores range 0-100, where higher scores indicate greater diet adherence (100%=perfect adherence).
Baseline, 6-months, and at 12-months
The Diet History Questionnaire (DHQ)
Time Frame: Baseline, 6-months, and at 12-months
The Diet History Questionnaire (DHQ) is a 161-item survey measuring the frequency of specific food, beverage, and supplement intake. The DHQ is not scored; rather, it offers a detailed look into one's dietary patterns and nutrition by quantifying the nutrients, dietary constituents, and food groups that an individual has consumed over the past month.
Baseline, 6-months, and at 12-months
The Insomnia Severity Index (ISI)
Time Frame: Baseline, 6-months, and at 12-months
The Insomnia Severity Index (ISI) is a 7-item questionnaire designed to assess the severity of insomnia symptoms. Each item is scored from 0 to 4, with higher scores indicating more acute symptoms. The total score is calculated by summing the individual item scores, resulting in a total range of 0-28. Scores are categorized as follows: 0-7 (No clinically significant insomnia), 8-14 (Subthreshold insomnia), 15-21 (Clinical insomnia - moderate), and 22-28 (Clinical insomnia - severe).
Baseline, 6-months, and at 12-months
The Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time Frame: Baseline, 6-months, and at 12-months
The Godin Leisure-Time Exercise Questionnaire (GLTEQ) is a tool used to assess weekly exercise habits, measuring both frequency (number of 15-minute sessions) and intensity (Light, Moderate, and Strenuous). A weekly leisure activity score is calculated using the formula: (9 × Strenuous) + (5 × Moderate) + (3 × Light). Higher scores indicate greater physical activity levels, with classifications as follows: ≥24 (Active), 14-23 (Moderately Active), and ≤14 (Insufficiently Active/Sedentary).
Baseline, 6-months, and at 12-months
Glial fibrillary acidic protein (GFAP) level
Time Frame: Baseline, 6-months, and at 12-months
GFAP is a protein expressed by astrocytes (supporting cells in the brain) that can be elevated in certain disorders like multiple sclerosis
Baseline, 6-months, and at 12-months
Lipid panel
Time Frame: Baseline, 6-months, and at 12-months
blood tests that measure the amount of fats in the blood
Baseline, 6-months, and at 12-months
Apolipoproteins level
Time Frame: Baseline, 6-months, and at 12-months
blood tests that measure the amount of fats in the blood
Baseline, 6-months, and at 12-months
Hemoglobin A1C Test
Time Frame: Baseline, 6-months, and at 12-months
A1C is a lab test that shows the average level of blood sugar (glucose) over the previous 3 months. It shows how well patients are controlling their blood sugar to help prevent complications from diabetes.
Baseline, 6-months, and at 12-months
Leukocyte telomere length (LTL)
Time Frame: Baseline, 6-months, and at 12-months
Leukocyte telomere length (LTL) measures biological aging (longer length associated with younger biological age). Biological age (BA) describes the extent of aging, based on the age of one's cells and tissues.
Baseline, 6-months, and at 12-months
The Expanded Disability Status Scale (EDSS)
Time Frame: Baseline, 6-months, and at 12-months
The Expanded Disability Status Scale (EDSS) helps to describe the extent to which one's MS affects their everyday functionality based on a neurological and physical exam. Total scale is scored from 1-10, with a higher score indicating greater levels of disability due to MS.
Baseline, 6-months, and at 12-months
The NHANES biological aging index (BAI)
Time Frame: Baseline, 6-months, and at 12-months
The NHANES Biological Aging Index (BAI) is a multi-marker index designed to estimate biological age relative to chronological age. It is derived from a mathematical equation that incorporates various biomarkers known to change with age. These biomarkers include resting blood pressure, forced expiratory volume (FEV1), and lab values such as serum creatinine, C-reactive protein, blood-urea nitrogen, albumin, alkaline phosphatase, cholesterol, cytomegalovirus (CMV) antibodies, and hemoglobin A1c. The index compares these values to a reference population of healthy individuals to estimate the rate of aging. A higher BAI score indicates faster aging of cells and tissues, while a lower score suggests slower aging. There is no defined minimum or maximum score for the BAI.
Baseline, 6-months, and at 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Icahn School of Medicine at Mount Sinai

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ilana B Katz Sand, MD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GCO 23-0300
  • RG-2407-43743 (Other Grant/Funding Number: National Multiple Sclerosis Society (NMSS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shared with qualified investigators upon request and review, in accordance with institutional policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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