Understanding the Impact of Meal Timing on Neurological Health in Adults With Multiple Sclerosis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07475377
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Time Restricted Eating — BEHAVIORAL
    Participants will eat all meals within 8 hours/day and fast for the remaining 16 hours/day.
  • Unrestricted eating — BEHAVIORAL
    Participants will eat all meals over 12 or more hours/day.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Aug 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
22 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Time Restricted Eating
    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.
  • Active Comparator: Unrestricted 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.

Primary Outcome Measure

Neurofilament light chain [ Time Frame: Baseline and 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Kathryn Green
[email protected]
Brooks C Wingo (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
University of Alabama at Birmingham· Birmingham, AL

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