Understanding the Impact of Meal Timing on Neurological Health in Adults With Multiple Sclerosis
Official 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. 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 Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 22 participants
Interventions
- BEHAVIORAL: Time Restricted Eating — Participants will eat all meals within 8 hours/day and fast for the remaining 16 hours/day.
- BEHAVIORAL: Unrestricted eating — Participants will eat all meals over 12 or more hours/day.
Primary Outcomes
- Neurofilament light chain (Baseline and 12 weeks)
Secondary Outcomes
- Brain Derived Neurotrophic Factor (Baseline and 12 weeks)
- Interleukin-6 (Baseline and 12 weeks)
- Interleukin-17 (Baseline and 12 weeks)
- Tumor necrosis factor-alpha (Baseline and 12 weeks)
- Change in circadian gene expression (Baseline, 12 weeks)
Trial Locations
- University of Alabama at Birmingham, Birmingham, Alabama, United States
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.