About 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Time Restricted Eating
- Unrestricted eating
Treatment groups
Sponsors and collaborators
University of Alabama at Birmingham
Lead sponsor
Paralyzed Veterans of America Research Foundation
Collaborator