- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07644000
Effect of Pre-exercise Inhalation of Molecular Hydrogen on Metabolic Response During Graded Exercise in Healthy Women
Effect of Repeated Pre-exercise Inhalation of Molecular Hydrogen on Metabolic Response During Graded Exercise in Healthy Women: A Randomized, Double-blind, Placebo-controlled Crossover Trial
The goal of this clinical trial is to evaluate if molecular hydrogen can reduce the metabolic response during graded exercise in healthy women aged 18-30 years. The main questions it aims to answer are:
- Does molecular hydrogen reduce the respiratory exchange ratio?
- Does molecular hydrogen reduce oxygen uptake?
Researchers will compare molecular hydrogen to a placebo (ambient air containing no molecular hydrogen) to see if molecular hydrogen reduces the metabolic response.
Participants will:
- Inhale molecular hydrogen for 60 minutes each day for 7 days.
- Undergo an exercise testing twice after a two-week washout period.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Tereza Rysava
- Número de teléfono: +420585636154
- Correo electrónico: tereza.rysava01@upol.cz
Copia de seguridad de contactos de estudio
- Nombre: Jakub Krejci, PhD
- Correo electrónico: jakub.krejci@upol.cz
Ubicaciones de estudio
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Olomouc, Chequia, 77111
- Reclutamiento
- Palacky University, Faculty of Physical Culture
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Contacto:
- Tereza Rysava
- Número de teléfono: +420585636154
- Correo electrónico: tereza.rysava01@upol.cz
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Healthy female participants.
- Regular menstrual cycle with exercise testing scheduled outside the menstrual phase.
- Signed informed consent.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- History or presence of cardiovascular disease.
- History or presence of respiratory disease.
- Regular use of medications affecting metabolism.
- Use of dietary supplements affecting metabolism within 14 days prior to intervention.
- Strenuous physical activity within 24 hours prior to exercise testing.
- Any contraindication to exercise testing or study participation determined by a physician.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Molecular hydrogen
Molecular hydrogen inhalation for 60 minutes daily for 7 days.
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Gas mixture containing 3.75% molecular hydrogen and ambient air.
Otros nombres:
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Comparador de placebos: Placebo
Ambient air inhalation for 60 minutes daily for 7 days.
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Ambient air without molecular hydrogen.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Respiratory exchange ratio
Periodo de tiempo: Change after 2 weeks of crossover.
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Respiratory exchange ratio is measured using an Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the exercise, and the average is calculated for 6-minute segments for subsequent analysis.
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Change after 2 weeks of crossover.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Oxygen uptake
Periodo de tiempo: Change after 2 weeks of crossover.
|
Oxygen uptake is measured using an Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the exercise, and the average is calculated for 6-minute segments for subsequent analysis.
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Change after 2 weeks of crossover.
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Carbon dioxide production
Periodo de tiempo: Change after 2 weeks of crossover.
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Carbon dioxide production is measured using an Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the exercise, and the average is calculated for 6-minute segments for subsequent analysis.
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Change after 2 weeks of crossover.
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Minute ventilation
Periodo de tiempo: Change after 2 weeks of crossover.
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Minute ventilation is measured using an Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the exercise, and the average is calculated for 6-minute segments for subsequent analysis.
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Change after 2 weeks of crossover.
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Breathing frequency
Periodo de tiempo: Change after 2 weeks of crossover.
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Breathing frequency is measured using an Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the exercise, and the average is calculated for 6-minute segments for subsequent analysis.
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Change after 2 weeks of crossover.
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Heart rate
Periodo de tiempo: Change after 2 weeks of crossover.
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Heart rate is continuously recorded during the exercise using a Polar H10 chest strap (Polar, Kempele, Finland), and the average is calculated for 6-minute segments for subsequent analysis.
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Change after 2 weeks of crossover.
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Blood lactate concentration
Periodo de tiempo: Change after 2 weeks of crossover.
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Capillary blood lactate concentration is assessed at baseline (resting condition) and during the final minute of each exercise step using a Lactate Scout device (EKF Diagnostics, Barleben, Germany).
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Change after 2 weeks of crossover.
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Rating of perceived exertion
Periodo de tiempo: Change after 2 weeks of crossover.
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Participants are asked to subjectively rate their perceived exertion at specified time points - at rest and subsequently in the last minute of each exercise step.
The Borg's scale 6-20 is used, where 6 means "no exertion" and 20 means "maximal exertion".
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Change after 2 weeks of crossover.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Blood glucose concentration
Periodo de tiempo: Change after 2 weeks of crossover.
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Capillary blood glucose concentration is assessed at baseline (resting condition) and during the final minute of each exercise step using an Accu-Chek Inform II device (Roche Diagnostics, Manheim, Germany).
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Change after 2 weeks of crossover.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tereza Rysava, Palacky University
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
- FTK_2026_14
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
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.
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