A Study of the MIND Diet for Persons With Multiple Sclerosis

Not Applicable

Not yet recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT06992115
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

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 Timeline

• Status Verified: 2025-05
• Study Start: 2025-05
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28
• Primary Completion: 2029-04-30
• Study Completion: 2029-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in plasma neurofilament light chain (NfL)	Baseline, 6-months, and at 12-months	Plasma NfL quantification will be reported in units of pg/ml.

Secondary Outcome Measures

Name	Time	Method
Neurological Fatigue Index-MS (NFI-MS)	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.
The Expanded Disability Status Scale (EDSS)	Baseline, 6-months, and at 12-months	The Expanded Disability Status Scale (EDSS) provides a score from 1-10 based on a neurological and physical exam. This score helps to describe the extent to which one's MS affects their everyday functionality, with a higher score indicating greater levels of disability due to MS.
The Symbol-Digit Modalities Test (SDMT)	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.
California Verbal Learning Test (CVLT-II)	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.
Brief Visuospatial Memory Test (BVMT-R)	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
The 9-Hole Peg Test (9HPT)	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.
Timed 25-Foot Walk (T25FW)	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.
The 2-Minute Walk Test	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.
Multiple Sclerosis Impact Scale (MSIS-29)	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.
Multiple Sclerosis Cognitive Scale (MSCS)	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.
MIND Diet Score	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.
MIND Diet Adherence Score	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).
The Diet History Questionnaire (DHQ)	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.
The Insomnia Severity Index (ISI)	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).
The Godin Leisure-Time Exercise Questionnaire (GLTEQ)	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).
Glial fibrillary acidic protein (GFAP) level	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
Lipid panel	Baseline, 6-months, and at 12-months	blood tests that measure the amount of fats in the blood
Apolipoproteins level	Baseline, 6-months, and at 12-months	blood tests that measure the amount of fats in the blood
Hemoglobin A1C Test	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.
The NHANES biological aging index (BAI)	Baseline, 6-months, and at 12-months	The NHANES biological aging index (BAI) multimarker index is calculated based on resting blood pressure, forced expiratory volume (FEV1), and lab values (serum creatinine, C-reactive protein, blood-urea nitrogen, albumin, alkaline phosphatase, cholesterol, cytomegalovirus (CMV) antibodies, and hemoglobin A1c).
Leukocyte telomere length (LTL)	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.

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States