Comprendre l'impact de l'horaire des repas sur la santé neurologique chez les adultes atteints de sclérose en plaques (Meal Time MS)
Comprendre l'impact du moment des repas sur la santé neurologique chez les adultes atteints de sclérose en plaques
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Brooks C Wingo, PhD
- Numéro de téléphone: 205-934-5982
- E-mail: bcwingo@uab.edu
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35294
- Recrutement
- University of Alabama at Birmingham
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Contact:
- Kathryn Green
- E-mail: kathryngreen@uabmc.edu
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Chercheur principal:
- Brooks C Wingo
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Chaîne légère des neurofilaments
Délai: Ligne de base et 12 semaines
|
Ligne de base et 12 semaines
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Facteur neurotrophique dérivé du cerveau
Délai: Baseline et 12 semaines
|
Baseline et 12 semaines
|
|
|
Interleukine-6
Délai: Ligne de base et 12 semaines
|
Ligne de base et 12 semaines
|
|
|
Interleukine-17
Délai: Ligne de base et 12 semaines
|
Ligne de base et 12 semaines
|
|
|
Facteur de nécrose tumorale alpha
Délai: Ligne de base et 12 semaines
|
Ligne de base et 12 semaines
|
|
|
Composé Fonctionnel de la Sclérose en Plaques
Délai: Ligne de base et 12 semaines
|
Ligne de base et 12 semaines
|
|
|
Change in circadian gene expression
Délai: 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
Délai: Baseline, 12 weeks
|
Change in expression of the following autophagy-related genes: LC3A, ATG5, ATG7, ATG12, LAMP2 |
Baseline, 12 weeks
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Neuroinflammation
Délai: Baseline, 12 weeks
|
Neuroinflammation will be measured with translocator protein (TSPO)-PET imaging |
Baseline, 12 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB-300016152
- 3212 (Autre subvention/numéro de financement: Paralyzed Veterans of America)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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