Forståelse af indflydelsen af måltidstidspunkter på neurologisk sundhed hos voksne med multipel sklerose (Meal Time MS)
Forståelse af betydningen af måltidstiming for neurologisk sundhed hos voksne med multipel sklerose
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Brooks C Wingo, PhD
- Telefonnummer: 205-934-5982
- E-mail: bcwingo@uab.edu
Studiesteder
-
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- Rekruttering
- University of Alabama at Birmingham
-
Kontakt:
- Kathryn Green
- E-mail: kathryngreen@uabmc.edu
-
Ledende efterforsker:
- Brooks C Wingo
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Aktiv komparator: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Neurofilament lys kæde
Tidsramme: Baseline og 12 uger
|
Baseline og 12 uger
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hjerneafledt neurotrofisk faktor
Tidsramme: Baseline og 12 uger
|
Baseline og 12 uger
|
|
|
Interleukin-6
Tidsramme: Baseline og 12 uger
|
Baseline og 12 uger
|
|
|
Interleukin-17
Tidsramme: Baseline og 12 uger
|
Baseline og 12 uger
|
|
|
Tumor nekrosefaktor-alfa
Tidsramme: Baseline og 12 uger
|
Baseline og 12 uger
|
|
|
Multiple Sclerosis Funktionskomposit
Tidsramme: Baseline og 12 uger
|
Baseline og 12 uger
|
|
|
Change in circadian gene expression
Tidsramme: 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
Tidsramme: Baseline, 12 weeks
|
Change in expression of the following autophagy-related genes: LC3A, ATG5, ATG7, ATG12, LAMP2 |
Baseline, 12 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Neuroinflammation
Tidsramme: Baseline, 12 weeks
|
Neuroinflammation will be measured with translocator protein (TSPO)-PET imaging |
Baseline, 12 weeks
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB-300016152
- 3212 (Andet bevillings-/finansieringsnummer: Paralyzed Veterans of America)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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