Understanding the Impact of Meal Timing on Neurological Health in Adults With Multiple Sclerosis (Meal Time MS)

March 16, 2026 updated by: Brooks C. Wingo, PhD, University of Alabama at Birmingham

The goal of this clinical trial is to learn if the time an individual eats each day impacts neurological health in people with multiple sclerosis. The main questions the investigators are asking are:

  1. Does meal timing affect biomarkers of neuronal health (neurofilament light chain [NfL] and BDNF) and inflammation (IL-6, IL-17, TNF-ɑ) in adults with MS.
  2. Does meal timing affect expression of circadian clock genes and genes associated with autophagy in adults with MS.

Participants will be instructed to start and stop eating at specific times each day based on their group assignment and their personal schedule. They will respond to prompts sent to them on their smartphone to record the times they start and stop eating each day.

As a secondary goal, the study will also explore the feasibility of including translocator protein (TSPO)-PET imaging of neuroinflammation in future clinical trials of TRE in people with MS. To accomplish this, imaging will be completed in a subset of 8 participants at the beginning and end of the study.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The mechanisms underlying the relationship between diet and MS are not well understood. A leading theory is that diet affects disease progression and symptoms through modulation of neuroinflammation. Previous studies in participants with other conditions suggest that time restricted eating (TRE) may reduce inflammation by improving circadian rhythms. If this holds true in people with MS, it may explain how TRE improves clinical outcomes of cognitive and physical function as seen in a previous trial. It may also explain diurnal fluctuations in pain and fatigue experienced by people within MS.

Although a previous study measured the effect of TRE on physical and cognitive function, as well as pain and fatigue, it was a single arm study and did not measure the hypothesized mechanisms of action. Therefore, the purpose of this pilot study is to examine the effects of TRE on neurological, inflammatory, and circadian markers in adults with MS.

Adults with relapsing forms of MS (relapsing remitting [RRMS] or secondary progressive [SPMS], n = 22) will be randomly assigned to either a TRE group that will eat all food within an 8-hour window each day (treatment group) or a group that will eat over 12 or more hours each day for 12 weeks.

Further, investigators will assess the feasibility of using Positron Emission Tomography (PET) imaging to measure changes in neuroinflammation with TRE. This exploratory aim will be completed in a subset of participants (n=8), and will be used to finalize imaging protocols and determine feasibility of including translocator protein (TSPO)-PET imaging of neuroinflammation in future clinical trials of TRE in people with MS.

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Brooks C Wingo, PhD
  • Phone Number: 205-934-5982
  • Email: bcwingo@uab.edu

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Brooks C Wingo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with relapsing remitting or secondary progressive multiple sclerosis (RRMS or SPMS)
  • If on disease modifying therapy (DMTs), stable for 6 months
  • If not on DMTs, no DMT usage within previous 6 months
  • BMI 18.5-50 kg/m2
  • Access to a smartphone
  • Responsible for personal eating schedule or able to have input into schedule

Exclusion Criteria:

  • Relapse within previous 30 days
  • Actively engaged in a weight loss program or unwilling to follow assigned eating schedule
  • Current use of GLP-1 or use within previous 3 months
  • Regularly fasts > 12 hours/day
  • Employed in night shift or rotating shift work
  • Unable to walk 25 feet with or without assistive device (EDSS > 6.5).
  • Current use of insulin or sulfonylurea agents
  • Pregnant or breastfeeding
  • Currently enrolled in another trial that would confound results (e.g., exercise studies or other diet studies)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Time Restricted Eating
Participants in this arm will eat all meals over the course of 8 hours/day. No instruction on type or amount of food will be given.
Behavioral: Time Restricted Eating
Participants will eat all meals within 8 hours/day and fast for the remaining 16 hours/day.
Active Comparator: Unrestricted Eating
Participants in this arm will eat all meals over the course of 12 or more hours/day. No instruction on type or amount of food will be given.
Behavioral: Unrestricted eating
Participants will eat all meals over 12 or more hours/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neurofilament light chain
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Derived Neurotrophic Factor
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Interleukin-6
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Interleukin-17
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Tumor necrosis factor-alpha
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Multiple Sclerosis Functional Composite
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in circadian gene expression
Time Frame: Baseline, 12 weeks
Change in expression of the following genes: CLOCK, PER2, BMAL1, PER1, PER2, CRY1, CRY2, REV-ERBA/NR1D1
Baseline, 12 weeks
Change in expression of autophagy genes
Time Frame: Baseline, 12 weeks
Change in expression of the following autophagy-related genes: LC3A, ATG5, ATG7, ATG12, LAMP2
Baseline, 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuroinflammation
Time Frame: Baseline, 12 weeks
Neuroinflammation will be measured with translocator protein (TSPO)-PET imaging
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Paralyzed Veterans of America Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300016152
  • 3212 (Other Grant/Funding Number: Paralyzed Veterans of America)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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