Creatine for Recovery and Thinking in Mothers (CREATE-MOM)
26 de agosto de 2026 actualizado por: University of North Carolina, Chapel Hill
Creatine for Recovery, Executive Function, Activity, Thinking & Energy in Mothers (CREATE-MOM)
The purpose of this randomized, double-blind, parallel-group trial is to compare the effects of two doses of creatine monohydrate (5 g/day versus 10 g/day) administered for four weeks in postpartum women.
The study will evaluate exercise performance, post-exercise recovery, cognitive function, and brain creatine concentrations in a sub-sample.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
Postpartum women frequently experience changes in physical performance, recovery, cognition, sleep quality, and mood.
Creatine supplementation may enhance energy availability in skeletal muscle and brain tissue, potentially improving exercise performance, recovery, and cognitive function.
This study will enroll 40 postpartum women and randomly assign participants in a 1:1 ratio to receive either 5 g/day or 10 g/day of creatine monohydrate for four weeks in a double-blind fashion.
Assessments will be conducted before and after supplementation and will include repeated sprint ability testing, skeletal muscle oxygen recovery, and cognitive testing.
A subsample of 20 participants will undergo magnetic resonance spectroscopy to assess brain creatine stores.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Abbie Smith-Ryan, PhD
- Número de teléfono: 919-962-2574
- Correo electrónico: abbiesmith@unc.edu
Copia de seguridad de contactos de estudio
- Nombre: Research Coordinator
- Número de teléfono: 919-962-1663
- Correo electrónico: aplresearch@unc.edu
Ubicaciones de estudio
-
-
North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- Applied Physiology Laboratory
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Contacto:
- Study Coordinator
- Número de teléfono: 919-962-1663
- Correo electrónico: aplresearch@unc.edu
-
Investigador principal:
- Abbie Smith-Ryan, PhD
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 6 weeks -12 months postpartum
- Body mass index of 18.5-34.9 kg/m2
- Cleared to resume physical activity
Exclusion Criteria:
- Experienced a musculoskeletal injury, excluding a Cesarean delivery,within the past three months that inhibits participation in the study.
- Has chronic kidney disease, liver disease, chronic obstructive pulmonary disease, or cancer
- Currently using medications that may directly impact the primary outcomes including: diuretics and corticosteroids).
- Has uncontrolled hypertension or diabetes, or has recently started medication, without a stable dose for 3 consecutive months.
- Currently using creatine monohydrate or other performance-enhancing supplements
- Has a self-identified or clinically diagnosed eating disorder
- Taking or having supplemented with creatine monohydrate in the last 28-days
- Medical contradictions for physical exercise
- Has participated in another clinical trial within 4-weeks prior to enrollment that in the opinion of the PI would influence the results.
- Has severely impaired hearing or speech or inability to speak English.
- Unwilling or unable to comply with the study protocol, including abstaining from caffeine, tobacco, alcohol, and physical activity before testing days.
- Is currently pregnant.
- Has a known allergy to the transducer gel used for the ultrasound
- Has a known allergy to creatine monohydrate
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Low-Dose Creatine Monohydrate
Participants consume 5 grams per day of creatine monohydrate for 28 consecutive days.
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Creatine monohydrate taken daily mixed with 6-8 oz of water.
|
|
Experimental: High-dose Creatine Monohydrate
Participants consume 10 grams per day of creatine monohydrate for 28 consecutive days.
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Creatine monohydrate taken daily mixed with 6-8 oz of water.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Repeated Sprint Ability Peak Power
Periodo de tiempo: Change from baseline to 4 weeks post-supplementation.
|
Peak power (Watts) measured during a repeated sprint ability cycling test.
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Change from baseline to 4 weeks post-supplementation.
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Fatigue Index
Periodo de tiempo: Change from baseline to 4 weeks post-supplementation.
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Fatigue index (%) calculated from repeated sprint ability testing.
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Change from baseline to 4 weeks post-supplementation.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Skeletal Muscle Oxygen Recovery
Periodo de tiempo: Change from baseline to 4 weeks post-supplementation
|
Recovery rate constant of skeletal muscle oxygen consumption following exercise measured by near-infrared spectroscopy and arterial occlusion procedures.
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Change from baseline to 4 weeks post-supplementation
|
|
Executive Function
Periodo de tiempo: Change from baseline to 4 weeks post-supplementation
|
Executive function measured using the NIH Toolbox Flanker Inhibitory Control and Attention Test.
|
Change from baseline to 4 weeks post-supplementation
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Working Memory
Periodo de tiempo: Change in baseline to 4 weeks post-supplementation.
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Working memory measured using the NIH Toolbox List Sorting Working Memory Test.
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Change in baseline to 4 weeks post-supplementation.
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Brain Creatine Concentration
Periodo de tiempo: Change from baseline to 4 weeks post-supplementation
|
Brain phosphocreatine and related bioenergetic metabolites assessed using phosphorus magnetic resonance spectroscopy (³¹P-MRS) in the imaging subsample
|
Change from baseline to 4 weeks post-supplementation
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Abbie Smith-Ryan, PhD, University of North Carolina, Chapel Hill
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
8 de septiembre de 2026
Finalización primaria (Estimado)
10 de mayo de 2027
Finalización del estudio (Estimado)
10 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
26 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de agosto de 2026
Publicado por primera vez (Actual)
31 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-1724
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Deidentified individual participant data that support the results reported in publications arising from this study will be shared beginning 9 to 36 months following publication, provided that the investigator requesting the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC) at Chapel Hill.
When data sharing is permitted, a Data Use Agreement specifying the permitted uses of the shared data must be fully executed before any data are released.
Marco de tiempo para compartir IPD
Data will be available beginning 9 to 36 months following publication of the primary study results and will remain available for a period determined by UNC data-sharing policies and the terms of the applicable Data Use Agreement.
Criterios de acceso compartido de IPD
Investigators seeking access to the data must provide documentation of IRB, IEC, or REB approval, where applicable, and enter into a fully executed Data Use Agreement with the University of North Carolina at Chapel Hill prior to receipt of data.
Requests will be reviewed by the study investigator and the University in accordance with institutional policies.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .