Randomized Controlled Trial of MIND Diet for Neuroprotection and Symptom Management in MS
Icahn School of Medicine at Mount Sinai
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.
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 w…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- BehavioralMediterranean-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.
- BehavioralSmall Group
Education and social support on topics related to multiple sclerosis such as disease-modifying therapies and MRI in MS.
Location
- Mount Sinai HospitalNew York, New York