- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02876770
Melatonin Supplementation and Performance (MSP)
18 de agosto de 2016 actualizado por: kais
Nocturnal Melatonin Ingestion Ameliorates Short Term Maximal Performances on the Following Day
The present study aimed to evaluate the possible effect of nocturnal melatonin ingestion upon short-term performances, on the following morning.
Twelve soccer players from a Tunisian squad (22.9 ±1.3 years, 1.80±0.05
m, and 72.0±8.8 kg) were volunteered to perform three testing sessions, with one test session per day.
During each session, MEL (5mg) , MEL (8mg) or placebo were ingested, in a randomized order, before nocturnal sleep.
The next morning (08:00h), participants performed the following psycho-cognitive and physical tests: Hooper's index, reaction time, vigilance, handgrip strength , squat jump , modified agility test , Wingate anaerobic test (peak power , mean power and fatigue index ).
Rating of perceived exertion was recorded immediately after the WanT, and blood lactate measures were taken after 3min of recovery.
Blood glucose was measured before and 3 min after the Wingate test.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
12
Fase
- Fase temprana 1
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
20 años a 23 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
The participants were recruited based on the following criteria: (i) paticipants must be trained at 4-6 days per week for an average of 2 h daily and (ii) they must have at least 8 years of training experience
Exclusion Criteria:
- Subjects were excluded from the study if they present one of the following criteria : heart failure, antioxidant supplementation within 3 months before the study, lower-limb injuries
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: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Placebo
|
In a double-blind randomized design, participants have taken placebo supplementation in one of the three experimental sessions
|
Experimental: Melatonina
|
Our protocol was composed of three experimental sessions.
During each testing session, participants were requested to attend the laboratory at 20:00h where they ingested a standardized light meal.
Melatonin (5 mg or 8 mg) or placebo were ingested in capsule in the evening at 21:00h in a double-blind randomized design
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Hooper's index score
Periodo de tiempo: At 07:30 am in the following day of the supplementation
|
Hooper's index score was measured using a specific questionnaire
|
At 07:30 am in the following day of the supplementation
|
handgrip strength (in Kg)
Periodo de tiempo: At 07:30 am in the following day of the supplementation
|
handgrip strength was measured using a calibrated hand dynamometer.
|
At 07:30 am in the following day of the supplementation
|
Blood lactate (µmol/l)
Periodo de tiempo: Blood lactate was measured only 3 minutes after physical testing in the following day of the supplementation
|
Lactate level was measured using Lactate Pro instrument.
|
Blood lactate was measured only 3 minutes after physical testing in the following day of the supplementation
|
reaction time (in secondes)
Periodo de tiempo: At 07:30 am in the following day of the supplementation
|
Reaction time was measured using an electronic timing device.
|
At 07:30 am in the following day of the supplementation
|
vigilance score
Periodo de tiempo: At 07:30 am in the following day of the supplementation
|
Vigilance score was measured using a specific questionnaire
|
At 07:30 am in the following day of the supplementation
|
squat jump (in centimeters)
Periodo de tiempo: At 07:30 am in the following day of the supplementation
|
Squat jump was assessed using a infrared jump system
|
At 07:30 am in the following day of the supplementation
|
agility (in secondes)
Periodo de tiempo: At 07:30 am in the following day of the supplementation
|
Agility was assessed using an electronic timing system.
|
At 07:30 am in the following day of the supplementation
|
anaerobic capacity (In watts)
Periodo de tiempo: At 07:30 am in the following day of the supplementation
|
Anaerobic capacity was assessed using a calibrated friction-loaded cycle ergometer
|
At 07:30 am in the following day of the supplementation
|
glucose level (µmol/l)
Periodo de tiempo: At 07:30 am in the following day of the supplementation (rest condition) and 3 minutes after physical testing in each experimental session
|
Glucose level was assessed using a glucometer
|
At 07:30 am in the following day of the supplementation (rest condition) and 3 minutes after physical testing in each experimental session
|
Rating of perceived exertion score
Periodo de tiempo: Rating of perceived exertion score was measured 3 minutes after physical testing in the following day of the supplementation
|
Rating of perceived exertion score was measured using a specific questionnaire
|
Rating of perceived exertion score was measured 3 minutes after physical testing in the following day of the supplementation
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
1 de diciembre de 2012
Finalización primaria (Actual)
1 de enero de 2013
Finalización del estudio (Actual)
1 de enero de 2013
Fechas de registro del estudio
Enviado por primera vez
2 de agosto de 2016
Primero enviado que cumplió con los criterios de control de calidad
18 de agosto de 2016
Publicado por primera vez (Estimar)
24 de agosto de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
24 de agosto de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
18 de agosto de 2016
Última verificación
1 de agosto de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CNMSS1
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. .
Ensayos clínicos sobre Actividad del motor
-
Kai Lutz, PhDUniversity of ZurichTerminadoAprendizaje motor | El rendimiento del motorSuiza
-
Sunnybrook Health Sciences CentreTerminado
-
Charles University, Czech RepublicReclutamientoActividad del motorChequia
-
Charles University, Czech RepublicActivo, no reclutando
-
University of MichiganTerminado
-
University of TriesteTerminado
-
University Hospital, GrenobleUniversité Joseph Fourier; Centre National de la Recherche Scientifique, FranceTerminadoActividad del motorFrancia
-
State University of New York - Upstate Medical...DesconocidoDesarrollo motor infantil
-
Rowe, Veronica, M.D.Terminado
Ensayos clínicos sobre Experimental: Melatonin
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)ReclutamientoVPH | Malignidad relacionada | Carcinoma relacionadoEstados Unidos
-
Polish Mother Memorial Hospital Research InstituteTerminadoLa alimentación con biberón | PrematuroPolonia
-
Aston UniversityBirmingham Women's and Children's NHS Foundation TrustReclutamientoEpilepsia refleja, fotosensible | Los anteojosReino Unido
-
Assistance Publique - Hôpitaux de ParisMedtronic - MITG; Kimberly-Clark CorporationTerminadoComplicación de ventilación mecánica | Insuficiencia respiratoria agudaFrancia
-
Wake Forest University Health SciencesMichael J. Fox Foundation for Parkinson's ResearchRetiradoEnfermedad de ParkinsonEstados Unidos
-
Finis Terrae UniversityAún no reclutandoDolor Postoperatorio | Complicación RespiratoriaChile
-
Le Mans UniversiteActivo, no reclutandoCáncer de mamaFrancia
-
Temple UniversityJohns Hopkins University; Penn State University; Memorial Health University Medical...TerminadoSaludableEstados Unidos
-
Universidade Federal do CearaDesconocido
-
Cardenal Herrera UniversityAún no reclutandoEsquizofreniaEspaña