Comprensión del impacto del horario de las comidas en la salud neurológica en adultos con esclerosis múltiple (Meal Time MS)
Comprender el impacto del momento de las comidas en la salud neurológica en adultos con esclerosis múltiple
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Brooks C Wingo, PhD
- Número de teléfono: 205-934-5982
- Correo electrónico: bcwingo@uab.edu
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- Reclutamiento
- University of Alabama at Birmingham
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Contacto:
- Kathryn Green
- Correo electrónico: kathryngreen@uabmc.edu
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Investigador principal:
- Brooks C Wingo
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
|
Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Cadena ligera de neurofilamento
Periodo de tiempo: Baseline y 12 semanas
|
Baseline y 12 semanas
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Factor Neurotrófico Derivado del Cerebro
Periodo de tiempo: Línea base y 12 semanas
|
Línea base y 12 semanas
|
|
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Interleucina-6
Periodo de tiempo: Línea base y 12 semanas
|
Línea base y 12 semanas
|
|
|
Interleucina-17
Periodo de tiempo: Baseline y 12 semanas
|
Baseline y 12 semanas
|
|
|
Factor de necrosis tumoral alfa
Periodo de tiempo: Línea de base y 12 semanas
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Línea de base y 12 semanas
|
|
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Compuesto Funcional de la Esclerosis Múltiple
Periodo de tiempo: Baseline y 12 semanas
|
Baseline y 12 semanas
|
|
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Change in circadian gene expression
Periodo de tiempo: 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
Periodo de tiempo: Baseline, 12 weeks
|
Change in expression of the following autophagy-related genes: LC3A, ATG5, ATG7, ATG12, LAMP2 |
Baseline, 12 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Neuroinflammation
Periodo de tiempo: Baseline, 12 weeks
|
Neuroinflammation will be measured with translocator protein (TSPO)-PET imaging |
Baseline, 12 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB-300016152
- 3212 (Otro número de subvención/financiamiento: Paralyzed Veterans of America)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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