Multiple SclerosisMeal Time MSNCT07475377
Understanding the Impact of Meal Timing on Neurological Health in Adults With Multiple Sclerosis
A study testing Time Restricted Eating and Unrestricted eating in people with Multiple Sclerosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Time Restricted Eating and Unrestricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Kathryn Green, kathryngreen@uabmc.edu
Brooks C Wingo
About this study
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:
- 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.
- Does meal timing affect expression of circadian clock genes and genes associated with autophagy in adults with MS.
Read more
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Time Restricted Eating, Unrestricted eating
- Keywords
- Nutrition, Circadian, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted EatingBehavioural
Participants will eat all meals within 8 hours/day and fast for the remaining 16 hours/day.
Unrestricted eatingBehavioural
Participants will eat all meals over 12 or more hours/day.
| Study group | Role | What they receive |
|---|---|---|
| Time Restricted Eating | Experimental | 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. Receives: Behavioral: Time Restricted Eating |
| Unrestricted Eating | Active comparator | 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. Receives: Behavioral: Unrestricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurofilament light chain
Measured: Baseline and 12 weeks
Secondary outcomes (7)
Brain Derived Neurotrophic Factor
Measured: Baseline and 12 weeks
Interleukin-6
Measured: Baseline and 12 weeks
Interleukin-17
Measured: Baseline and 12 weeks
Tumor necrosis factor-alpha
Measured: Baseline and 12 weeks
Change in circadian gene expression
Change in expression of the following genes: CLOCK, PER2, BMAL1, PER1, PER2, CRY1, CRY2, REV-ERBA/NR1D1
Measured: Baseline, 12 weeks
Change in expression of autophagy genes
Change in expression of the following autophagy-related genes: LC3A, ATG5, ATG7, ATG12, LAMP2
Measured: Baseline, 12 weeks
Multiple Sclerosis Functional Composite
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Aug 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Paralyzed Veterans of America Research Foundation
- Responsible party
- Principal investigator, Brooks C. Wingo, PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475377
- Sponsor's protocol ID
- IRB-300016152
- Other IDs
- 3212
- Acronym
- Meal Time MS
- Status last verified
- Sep 2026
- First submitted
- 11 Mar 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Impact of Meal Timing on Neurological Health in Adults With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07475377
- Acronym / sponsor ID
- Meal Time MS / IRB-300016152
- Conditions
- Multiple Sclerosis
- Keywords
- Nutrition, Circadian, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Paralyzed Veterans of America Research Foundation
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Eating | Experimental | Behavioral: Time Restricted EatingParticipants 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. |
| Unrestricted Eating | Active comparator | Behavioral: Unrestricted eatingParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Restricted EatingParticipants will eat all meals within 8 hours/day and fast for the remaining 16 hours/day. | Behavioural | Time Restricted Eating |
| Unrestricted eatingParticipants will eat all meals over 12 or more hours/day. | Behavioural | Unrestricted Eating |
Primary outcome
Neurofilament light chain
Time frame: Baseline and 12 weeks
7 secondary outcomes
Brain Derived Neurotrophic Factor
Time frame: Baseline and 12 weeks
Interleukin-6
Time frame: Baseline and 12 weeks
Interleukin-17
Time frame: Baseline and 12 weeks
Tumor necrosis factor-alpha
Time frame: Baseline and 12 weeks
Change in circadian gene expression
Time frame: Baseline, 12 weeks
Change in expression of autophagy genes
Time frame: Baseline, 12 weeks
Multiple Sclerosis Functional Composite
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Eating and Unrestricted eating in people with Multiple Sclerosis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brooks C Wingo, PhD (205-934-5982, bcwingo@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurofilament light chain (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.