Inzicht in de impact van maaltijdtiming op neurologische gezondheid bij volwassenen met multiple sclerose (Meal Time MS)
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:
- 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.
- 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The mechanisms underlying the relationship between diet and MS are not well understood. A leading theory is that diet affects disease progression and symptoms through modulation of neuroinflammation. Previous studies in participants with other conditions suggest that time restricted eating (TRE) may reduce inflammation by improving circadian rhythms. If this holds true in people with MS, it may explain how TRE improves clinical outcomes of cognitive and physical function as seen in a previous trial. It may also explain diurnal fluctuations in pain and fatigue experienced by people within MS.
Although a previous study measured the effect of TRE on physical and cognitive function, as well as pain and fatigue, it was a single arm study and did not measure the hypothesized mechanisms of action. Therefore, the purpose of this pilot study is to examine the effects of TRE on neurological, inflammatory, and circadian markers in adults with MS.
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.
Further, investigators will assess the feasibility of using Positron Emission Tomography (PET) imaging to measure changes in neuroinflammation with TRE. This exploratory aim will be completed in a subset of participants (n=8), and will be used to finalize imaging protocols and determine feasibility of including translocator protein (TSPO)-PET imaging of neuroinflammation in future clinical trials of TRE in people with MS.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Brooks C Wingo, PhD
- Telefoonnummer: 205-934-5982
- E-mail: bcwingo@uab.edu
Studie Locaties
-
-
Alabama
-
Birmingham, Alabama, Verenigde Staten, 35294
- Werving
- University of Alabama at Birmingham
-
Contact:
- Kathryn Green
- E-mail: kathryngreen@uabmc.edu
-
Hoofdonderzoeker:
- Brooks C Wingo
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
Participants will eat all meals within 8 hours/day and fast for the remaining 16 hours/day. |
|
Actieve vergelijker: 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. |
Participants will eat all meals over 12 or more hours/day. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Neurofilament lichtketen
Tijdsspanne: Baseline en 12 weken
|
Baseline en 12 weken
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Hersenaangroeiende factor
Tijdsspanne: Baseline en 12 weken
|
Baseline en 12 weken
|
|
|
Interleukine-6
Tijdsspanne: Baseline en 12 weken
|
Baseline en 12 weken
|
|
|
Interleukine-17
Tijdsspanne: Baseline en 12 weken
|
Baseline en 12 weken
|
|
|
Tumor necrosis factor-alfa
Tijdsspanne: Baseline en 12 weken
|
Baseline en 12 weken
|
|
|
Multiple Sclerose Functioneel Samengesteld
Tijdsspanne: Baseline en 12 weken
|
Baseline en 12 weken
|
|
|
Change in circadian gene expression
Tijdsspanne: Baseline, 12 weeks
|
Change in expression of the following genes: CLOCK, PER2, BMAL1, PER1, PER2, CRY1, CRY2, REV-ERBA/NR1D1 |
Baseline, 12 weeks
|
|
Change in expression of autophagy genes
Tijdsspanne: Baseline, 12 weeks
|
Change in expression of the following autophagy-related genes: LC3A, ATG5, ATG7, ATG12, LAMP2 |
Baseline, 12 weeks
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Neuroinflammation
Tijdsspanne: Baseline, 12 weeks
|
Neuroinflammation will be measured with translocator protein (TSPO)-PET imaging |
Baseline, 12 weeks
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB-300016152
- 3212 (Ander subsidie-/financieringsnummer: Paralyzed Veterans of America)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .