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

ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniversity of Alabama at Birmingham

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: Time Restricted EatingExperimental treatment 1 intervention
Group B: Unrestricted EatingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Neurofilament light chain

Time frame
Baseline and 12 weeks

Secondary outcomes

1

Brain Derived Neurotrophic Factor

Time frame
Baseline and 12 weeks
2

Interleukin-6

Time frame
Baseline and 12 weeks
3

Interleukin-17

Time frame
Baseline and 12 weeks
4

Tumor necrosis factor-alpha

Time frame
Baseline and 12 weeks

Other outcomes

1

Neuroinflammation

Neuroinflammation will be measured with translocator protein (TSPO)-PET imaging

Time frame
Baseline, 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Paralyzed Veterans of America Research Foundation

Collaborator

Source ClinicalTrials.gov
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