NCT06992115

A Study of the MIND Diet for Persons With Multiple Sclerosis

Randomized Controlled Trial of MIND Diet for Neuroprotection and Symptom Management in MS

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-12
• Primary completion: 2029-04-30
• Completion: 2029-04-30
• First posted: 2025-05-28
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States