MIND Diet for Multiple Sclerosis

Overseen By Claire E Wigley, Bsc, BSPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Alzheimer's, Stroke, Cancer, others

Compensation: Varies

Number of Visits: 3

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ilana B Katz Sand, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for individuals with Multiple Sclerosis who are interested in exploring how a specific diet, called the MIND diet, might affect their brain health and MS symptoms. Participants should be willing to either change their eating habits or continue their current diet for one year and provide blood & stool samples along with completing assessments.

Inclusion Criteria

I have been diagnosed with multiple sclerosis, regardless of my treatment status.

MIND diet score of ≤8 at baseline

I am between 18 and 70 years old.

Exclusion Criteria

I do not have a serious illness that could affect my participation or the study results.

Pregnancy/planning during study period

I have been diagnosed with another serious brain condition, like Alzheimer's or had a stroke.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments including blood and stool samples, online questionnaires, and functional & cognitive assessments

1 visit

1 visit (in-person)

Dietary Intervention

Participants in the intervention arm follow the MIND diet for one year with diet-related education and support, while control arm participants continue their current diet

12 months

Weekly virtual meetings for the first month, then monthly

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 and 12 months

6 months

2 visits (in-person) at 6 and 12 months

Treatment Details

Interventions

• MIND Diet

Trial Overview The study tests the effects of the MIND Diet on people with MS by comparing two groups: one follows the MIND Diet with support programs, while the other continues their usual diet but receives unrelated MS education. The trial lasts one year and includes online questionnaires and three in-person evaluations.

Participant Groups

Group I: MIND Diet Experimental Treatment 2 Interventions

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

Group II: Continue Diet Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+