Recruiting

MIND Diet

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06992115

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet

Small Group

Study Details

Brief 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.

Conditions

Multiple Sclerosis

Study ID

NCT06992115

Start date

May 12, 2025

Status verified date

Oct, 2025

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MIND Diet

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

placebo comparator: Continue Diet

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.

Interventions

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.

Small Group

Education and social support on topics related to multiple sclerosis such as disease-modifying therapies and MRI in MS.

Primary outcome measure

  • Changes in plasma neurofilament light chain (NfL) [ Time Frame: Baseline, 6-months, and at 12-months ]

Central Contacts and Locations

Central contacts

Claire E Wigley, Bsc, BSPH

(212) 241-3759claire.wigley@mssm.edu

Susan Filomena

212-241-3841susan.filomena@mssm.edu

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Ilana B Katz Sand, MD

212-241-6854ilana.katzsand@mssm.edu

Principal Investigator:

Ilana B Katz Sand

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Keywords

  • Multiple Sclerosis
  • Diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-10-14.