A Study of the MIND Diet for Persons With Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet, Small Group.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Controlled Trial of MIND Diet for Neuroprotection and Symptom Management in MS
Overview
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.
Interventions
- 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.
Primary outcome measures
- Changes in plasma neurofilament light chain (NfL) [Time frame: Baseline, 6-months, and at 12-months]
Secondary outcome measures (12)
- Neurological Fatigue Index-MS (NFI-MS) [Time frame: Baseline, 6-months, and at 12-months]
- The Expanded Disability Status Scale (EDSS) [Time frame: Baseline, 6-months, and at 12-months]
- The Symbol-Digit Modalities Test (SDMT) [Time frame: Baseline, 6-months, and at 12-months]
- California Verbal Learning Test (CVLT-II) [Time frame: Baseline, 6-months, and at 12-months]
- Brief Visuospatial Memory Test (BVMT-R) [Time frame: Baseline, 6-months, and at 12-months]
- The 9-Hole Peg Test (9HPT) [Time frame: Baseline, 6-months, and at 12-months]
- Timed 25-Foot Walk (T25FW) [Time frame: Baseline, 6-months, and at 12-months]
- The 2-Minute Walk Test [Time frame: Baseline, 6-months, and at 12-months]
- Multiple Sclerosis Impact Scale (MSIS-29) [Time frame: Baseline, 6-months, and at 12-months]
- Multiple Sclerosis Cognitive Scale (MSCS) [Time frame: Baseline, 6-months, and at 12-months]
- MIND Diet Score [Time frame: Baseline, 6-months, and at 12-months]
- MIND Diet Adherence Score [Time frame: Baseline, 6-months, and at 12-months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mount Sinai Hospital — New York
Identifiers
NCT: NCT06992115 · GCO 23-0300 · RG-2407-43743