Time Restricted Eating for Multiple Sclerosis
(Meal Time MS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are assigned to either a Time Restricted Eating group or an Unrestricted Eating group for 12 weeks
Imaging Sub-study
A subset of participants undergoes TSPO-PET imaging to assess neuroinflammation
Follow-up
Participants are monitored for changes in circadian gene expression and autophagy gene expression
What Are the Treatments Tested in This Trial?
Interventions
- Time Restricted Eating
- Unrestricted eating
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Paralyzed Veterans of America Research Foundation
Collaborator
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