- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07611877
Ecklonia Cava Supplementation and Cycling Performance
Acute Ecklonia Cava Supplementation Fails to Enhance Performance in Trained Cyclists
The goal of this clinical trial (randomised, double-blind, placebo-controlled crossover study) is to investigate whether supplementation with Ecklonia cava, a natural extract derived from brown seaweed, affects exercise performance and physiological responses in trained cyclists.
The main questions it aims to answer are:
Does Ecklonia cava supplementation improve cycling performance, including power output during steady-state exercise and short maximal sprints? Does Ecklonia cava supplementation influence physiological responses to exercise, such as blood glucose, blood lactate, heart rate, and oxygen consumption?
Researchers will compare Ecklonia cava supplementation to a placebo (a look-alike substance with no active ingredients) to determine whether the supplement has any effect on performance or physiological responses.
In this crossover design, all participants will receive both the Ecklonia cava supplement and the placebo on separate occasions, with a washout period between conditions.
Participants will:
Ingest either Ecklonia cava or a placebo 30 minutes before exercise testing Complete a 60-minute cycling protocol at a moderate intensity Perform repeated short-duration maximal sprint efforts following the steady-state exercise Attend laboratory testing sessions under both supplement and placebo conditions Undergo measurements of physiological responses, including blood glucose, blood lactate, heart rate, oxygen consumption, and respiratory exchange ratio Have exercise performance assessed through measures of power output during cycling
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kingston upon Thames, Reino Unido, KT1 2EE
- Department of Applied and Human Sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- experienced in cycling (defined as completing at least four hours of cycle training per week with a minimum of two years of experience)
Exclusion Criteria:
- Smoker
- cardiovascular disease
- anti-hypertensive medication
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Suplementación con placebo
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Placebo Supplementation
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Experimental: Ecklonia Cava Supplementation
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Ecklonia Cava Supplementation
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Peak Power Output During Sprint Performance (Watts)
Periodo de tiempo: Immediately after the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Peak power output achieved during 20-second maximal sprint efforts performed following a fixed-intensity (55% Wmax) 60-minute cycling protocol
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Immediately after the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Mean Power Output During Sprint Performance (Watts)
Periodo de tiempo: Immediately after the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Mean power output recorded during repeated 20-second maximal sprint efforts following steady-state cycling
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Immediately after the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Blood Lactate Concentration During Sprint Cycling (mmol/L)
Periodo de tiempo: Repeated sprint cycling (3) completed immediately after the 60-minute submaximal cycling protocol, a blood sample taken 2 minutes after each sprint cycling bout. Following each 30-minute supplementation protocol.
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Blood lactate concentration measured following each repeated sprint efforts (3)
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Repeated sprint cycling (3) completed immediately after the 60-minute submaximal cycling protocol, a blood sample taken 2 minutes after each sprint cycling bout. Following each 30-minute supplementation protocol.
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Blood Glucose Concentration During Sprint Cycling (mmol/L)
Periodo de tiempo: Repeated sprint cycling (3) completed immediately after the 60-minute submaximal cycling protocol, a blood sample taken 2 minutes after each sprint cycling bout. Following each 30-minute supplementation protocol.
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Blood glucose concentration measured following repeated sprint efforts
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Repeated sprint cycling (3) completed immediately after the 60-minute submaximal cycling protocol, a blood sample taken 2 minutes after each sprint cycling bout. Following each 30-minute supplementation protocol.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Heart Rate During Submaximal Cycling (beats per minute)
Periodo de tiempo: During the 60-minute submaximal cycling protocol, 30 minutes after supplementation (each condition)
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Average heart rate measured during a 60-minute steady-state cycling protocol performed at 55% maximal power output
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During the 60-minute submaximal cycling protocol, 30 minutes after supplementation (each condition)
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Blood Lactate Concentration During Submaximal Cycling (mmol/L)
Periodo de tiempo: Every 20-minutes during the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Blood lactate concentration measured during steady-state cycling at 55% maximal power output
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Every 20-minutes during the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Blood Glucose Concentration During Submaximal Cycling (mmol/L)
Periodo de tiempo: Every 20-minutes during the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Blood glucose concentration measured during steady-state cycling at 55% maximal power output
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Every 20-minutes during the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Oxygen Consumption (VO₂) During Submaximal Cycling (ml/kg/min)
Periodo de tiempo: During the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Oxygen consumption measured using indirect calorimetry during steady-state cycling
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During the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Respiratory Exchange Ratio (RER) During Submaximal Cycling
Periodo de tiempo: During the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Respiratory exchange ratio measured during steady-state cycling using expired gas analysis
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During the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1501 (CSL Behring)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .