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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 64 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Adults with relapsing forms of MS (relapsing remitting \[RRMS\] or secondary progressive \[SPMS\], n = 22) will be randomly assigned to either a TRE group that will eat all food within an 8-hour window each day (treatment group) or a group that will eat over 12 or more hours each day for 12 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether daily meal timing affects nerve health and inflammation in adults with multiple sclerosis (MS). It also looks at genes that control the body clock and cell cleanup. Participants will follow set eating times and record them on a smartphone.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have relapsing-remitting MS (symptoms come and go) or secondary progressive MS (symptoms worsen over time after a relapsing-remitting phase).
  • If taking MS disease-modifying treatment, which helps slow the disease, it must have been stable for 6 months.
  • If not taking MS disease-modifying treatment, have not used it in the past 6 months.
  • Have a body mass index (BMI), a measure based on height and weight, of 18.5–50.
  • Have access to a smartphone.
  • Control your eating schedule or have a say in it.

Who can't join

  • Had an MS relapse, or flare-up, in the past 30 days.
  • Are in a weight loss program or are unwilling to follow the assigned eating schedule.
  • Use a GLP-1 medicine, a type of diabetes or weight loss drug, or used one in the past 3 months.
  • Regularly go more than 12 hours a day without eating.
  • Work night shifts or rotating shifts.
  • Cannot walk 25 feet, even with a walking aid.
  • Use insulin or sulfonylurea medicines to lower blood sugar, or are pregnant or breastfeeding.
  • Are in another study that could affect the results, such as an exercise or diet study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 * Access to a smartphone * Responsible for personal eating schedule or able to have input into schedule Exclusion Criteria: * 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 * Employed in night shift or rotating shift work * Unable to walk 25 feet with or without assistive device (EDSS \> 6.5). * Current use of insulin or sulfonylurea agents * Pregnant or breastfeeding * Currently enrolled in another trial that would confound results (e.g., exercise studies or other diet studies)

Study sites (1)

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