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Effect of Pre-exercise Inhalation of Molecular Hydrogen on Metabolic Response During Graded Exercise in Healthy Women

22 de junio de 2026 actualizado por: Jakub Krejci, Palacky University

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

Reclutamiento

Condiciones

Descripción detallada

This crossover trial examines the effect of repeated inhalation of molecular hydrogen on the metabolic response during graded exercise in healthy female participants. Each participant undergoes two experimental interventions (molecular hydrogen and placebo) in random order, separated by a two-week washout period. The order of the interventions is randomized using a computer random number generator. Each intervention consists of 7 days, during which participants inhale either molecular hydrogen or placebo gas for 60 minutes daily under resting conditions. Molecular hydrogen is produced by electrolysis of water and mixed with ambient air in the chamber to achieve a hydrogen concentration of 3.75 % which is below the lower explosive limit. This gas is administered via a face mask connected to an Ambu bag system with a one-way valve to ensure standardized delivery. Placebo is produced by pumping ambient air without molecular hydrogen. Molecular hydrogen is colorless, odorless, and tasteless, making it indistinguishable from placebo by human senses. On the 7th day of each intervention, participants undergo a graded exercise test on an bicycle ergometer immediately following the final inhalation session. The protocol consists of 8 incremental steps with the workload increasing from 0.5 to 2.25 W/kg. Outcome measures collected at rest before exercise and during exercise include cardiorespiratory variables, capillary blood biomarkers, and perceived exertion. Statistical analysis is based on a two-way analysis of variance for repeated measures, and p < 0.05 is considered statistically significant.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

22

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

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • Olomouc, Chequia, 77111
        • Reclutamiento
        • Palacky University, Faculty of Physical Culture
        • Contacto:

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

Sí

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

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 cruzada
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Molecular hydrogen
Molecular hydrogen inhalation for 60 minutes daily for 7 days.
Gas mixture containing 3.75% molecular hydrogen and ambient air.
Otros nombres:
  • H2 Air-Blend Generator (H2 Medical Technologies, Ostrava, Czech Republic)
Comparador de placebos: Placebo
Ambient air inhalation for 60 minutes daily for 7 days.
Ambient air without molecular hydrogen.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Respiratory exchange ratio
Periodo de tiempo: Change after 2 weeks of crossover.
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.
Change after 2 weeks of crossover.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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.
Change after 2 weeks of crossover.
Carbon dioxide production
Periodo de tiempo: Change after 2 weeks of crossover.
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.
Change after 2 weeks of crossover.
Minute ventilation
Periodo de tiempo: Change after 2 weeks of crossover.
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.
Change after 2 weeks of crossover.
Breathing frequency
Periodo de tiempo: Change after 2 weeks of crossover.
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.
Change after 2 weeks of crossover.
Heart rate
Periodo de tiempo: Change after 2 weeks of crossover.
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.
Change after 2 weeks of crossover.
Blood lactate concentration
Periodo de tiempo: Change after 2 weeks of crossover.
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).
Change after 2 weeks of crossover.
Rating of perceived exertion
Periodo de tiempo: Change after 2 weeks of crossover.
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".
Change after 2 weeks of crossover.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Blood glucose concentration
Periodo de tiempo: Change after 2 weeks of crossover.
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).
Change after 2 weeks of crossover.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Tereza Rysava, Palacky University

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 (Actual)

22 de junio de 2026

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

8 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de junio de 2026

Publicado por primera vez (Actual)

12 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

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)?

SÍ

Descripción del plan IPD

All IPD that underlie results in a publication.

Marco de tiempo para compartir IPD

Beginning 1 month after the publication of results with no end date.

Criterios de acceso compartido de IPD

Anonymized IPD will be uploaded to an open-access data repository.

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. .

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