NCT07475377

Brief 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. 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. 2.Does meal timing affect expression of circadian clock genes and genes associated with autophagy in adults with MS.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
19mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
May 2026Dec 2027

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

March 11, 2026

Last Update Submit

March 16, 2026

Conditions

Multiple Sclerosis

Keywords

NutritionCircadianMultiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Neurofilament light chain

    Baseline and 12 weeks

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Other Outcomes (1)

  • Neuroinflammation

    Baseline, 12 weeks

Study Arms (2)

Time Restricted Eating

EXPERIMENTAL

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.

Behavioral: Time Restricted Eating

Unrestricted Eating

ACTIVE COMPARATOR

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.

Behavioral: Unrestricted eating

Interventions

Time Restricted EatingBEHAVIORAL

Participants will eat all meals within 8 hours/day and fast for the remaining 16 hours/day.

Time Restricted Eating
Unrestricted eatingBEHAVIORAL

Participants will eat all meals over 12 or more hours/day.

Unrestricted Eating

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Brooks C Wingo, PhD

CONTACT

205-934-5982bcwingo@uab.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)