A Study of the MIND Diet for Persons With Multiple Sclerosis
ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 18-70 years, inclusive
MS diagnosis, on any treatment (including no treatment)
MIND diet score of ≤9 at baseline
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet
BehavioralA 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
BehavioralEducation and social support on topics related to multiple sclerosis such as disease-modifying therapies and MRI in MS.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: MIND DietExperimental treatment 2 interventions
Group B: Continue DietPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in plasma neurofilament light chain (NfL)
Plasma NfL quantification will be reported in units of pg/ml.
Time frame
Baseline, 6-months, and at 12-monthsSecondary outcomes
1
Neurological Fatigue Index-MS (NFI-MS)
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.
Time frame
Baseline, 6-months, and at 12-months2
The Expanded Disability Status Scale (EDSS)
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.
Time frame
Baseline, 6-months, and at 12-months3
The Symbol-Digit Modalities Test (SDMT)
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.
Time frame
Baseline, 6-months, and at 12-months4
California Verbal Learning Test (CVLT-II)
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.
Time frame
Baseline, 6-months, and at 12-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov