An interventional study of Time Restricted Eating and Unrestricted eating in Multiple Sclerosis, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
Among 21 studies in Multiple Sclerosis by University of Alabama at Birmingham — 2 open to participants now, 3 under way, none of them phase 3. Multiple Sclerosis · University of Alabama at Birmingham.
Among the 21 studies in Multiple Sclerosis by University of Alabama at Birmingham, this one is the 13th largest by planned enrollment of the 20 interventional ones, is the only one that started in 2026, is one of 18 with no phase, and was the 21st registered.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 22 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →2 of the 21 studies in Multiple Sclerosis by University of Alabama at Birmingham are open now, in 1 country. Each count lists the studies.
Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years to 64 Years · all sexes · no healthy volunteers.
The full table on the hub →21 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 1 started in 2026.
Median enrollment 27 across the 20 interventional studies, 95 across the 1 observational. Of the 16 that completed or were terminated, 4 (25%) have results posted.
University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
1 of the studies in Multiple Sclerosis by University of Alabama at Birmingham that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07475377University of Alabama at BirminghamUnderstanding the Impact of Meal Timing on Neurological Health in Adults With Multiple Sclerosis | 2027-09-01 |
Among the 21 studies in Multiple Sclerosis by University of Alabama at Birmingham, from their registry updates:
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:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 within 8 hours/day and fast for the remaining 16 hours/day.
Participants will eat all meals over 12 or more hours/day.
Neurofilament light chain
Time frame: Baseline and 12 weeks
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
Change in expression of the following genes: CLOCK, PER2, BMAL1, PER1, PER2, CRY1, CRY2, REV-ERBA/NR1D1
Time frame: Baseline, 12 weeks
Change in expression of autophagy genes
Change in expression of the following autophagy-related genes: LC3A, ATG5, ATG7, ATG12, LAMP2
Time frame: Baseline, 12 weeks
Multiple Sclerosis Functional Composite
Time frame: Baseline and 12 weeks
Neuroinflammation
Neuroinflammation will be measured with translocator protein (TSPO)-PET imaging
Time frame: Baseline, 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Sep 2027, 13 months after the start.
Of 847 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 13 months is below that.
Counting every sponsor, half of 869 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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