A Study of the MIND Diet for Persons With Multiple Sclerosis

Mount Sinai Health System

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Behavioral: Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet; Behavioral: Small Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06992115

RG-2407-43743 (Other Grant/Funding Number)

GCO 23-0300

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups, including a placebo group

MIND Diet

Experimental group

Description:

Participants randomized to the intervention arm will change their dietary patterns to adhere to the MIND diet for one year after randomization.

Treatment:

Behavioral: Small Group

Behavioral: Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet

Continue Diet

Placebo Comparator group

Description:

Participants randomized to the control arm will continue their current dietary habits, without major changes, for one year after randomization. Participants will not receive diet education in small group.

Treatment:

Behavioral: Small Group