Clinical trial NCT06992115: A Study of the MIND Diet for Persons With Multiple Sclerosis
Official title: Randomized Controlled Trial of MIND Diet for Neuroprotection and Symptom Management in MS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Diet
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in plasma neurofilament light chain (NfL)
timeFrame: Baseline, 6-months, and at 12-months
Secondary outcomes:
measure: Neurological Fatigue Index-MS (NFI-MS)
timeFrame: Baseline, 6-months, and at 12-months
measure: The Expanded Disability Status Scale (EDSS)
timeFrame: Baseline, 6-months, and at 12-months
measure: The Symbol-Digit Modalities Test (SDMT)
timeFrame: Baseline, 6-months, and at 12-months
measure: California Verbal Learning Test (CVLT-II)
timeFrame: Baseline, 6-months, and at 12-months
measure: Brief Visuospatial Memory Test (BVMT-R)
timeFrame: Baseline, 6-months, and at 12-months
measure: The 9-Hole Peg Test (9HPT)
timeFrame: Baseline, 6-months, and at 12-months
measure: Timed 25-Foot Walk (T25FW)
timeFrame: Baseline, 6-months, and at 12-months
measure: The 2-Minute Walk Test
timeFrame: Baseline, 6-months, and at 12-months
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: Baseline, 6-months, and at 12-months
measure: Multiple Sclerosis Cognitive Scale (MSCS)
timeFrame: Baseline, 6-months, and at 12-months
measure: MIND Diet Score
timeFrame: Baseline, 6-months, and at 12-months
measure: MIND Diet Adherence Score
timeFrame: Baseline, 6-months, and at 12-months
measure: The Diet History Questionnaire (DHQ)
timeFrame: Baseline, 6-months, and at 12-months
measure: The Insomnia Severity Index (ISI)
timeFrame: Baseline, 6-months, and at 12-months
measure: The Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: Baseline, 6-months, and at 12-months
measure: Glial fibrillary acidic protein (GFAP) level
timeFrame: Baseline, 6-months, and at 12-months
measure: Lipid panel
timeFrame: Baseline, 6-months, and at 12-months
measure: Apolipoproteins level
timeFrame: Baseline, 6-months, and at 12-months
measure: Hemoglobin A1C Test
timeFrame: Baseline, 6-months, and at 12-months
measure: The NHANES biological aging index (BAI)
timeFrame: Baseline, 6-months, and at 12-months
measure: Leukocyte telomere length (LTL)
timeFrame: Baseline, 6-months, and at 12-months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ilana B Katz Sand, MD
role: PRINCIPAL_INVESTIGATOR
References: