Effect of Pre-exercise Inhalation of Molecular Hydrogen on Metabolic Response During Graded Exercise in Healthy Women
22 de junho de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
22
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Tereza Rysava
- Número de telefone: +420585636154
- E-mail: tereza.rysava01@upol.cz
Estude backup de contato
- Nome: Jakub Krejci, PhD
- E-mail: jakub.krejci@upol.cz
Locais de estudo
-
-
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Olomouc, Tcheca, 77111
- Recrutamento
- Palacky University, Faculty of Physical Culture
-
Contato:
- Tereza Rysava
- Número de telefone: +420585636154
- E-mail: tereza.rysava01@upol.cz
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Molecular hydrogen
Molecular hydrogen inhalation for 60 minutes daily for 7 days.
|
Gas mixture containing 3.75% molecular hydrogen and ambient air.
Outros nomes:
|
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Comparador de Placebo: Placebo
Ambient air inhalation for 60 minutes daily for 7 days.
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Ambient air without molecular hydrogen.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Respiratory exchange ratio
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Oxygen uptake
Prazo: 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
Prazo: 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
Prazo: 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.
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Change after 2 weeks of crossover.
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Breathing frequency
Prazo: 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.
|
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Heart rate
Prazo: 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.
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Change after 2 weeks of crossover.
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Blood lactate concentration
Prazo: 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).
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Change after 2 weeks of crossover.
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Rating of perceived exertion
Prazo: 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".
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Change after 2 weeks of crossover.
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Blood glucose concentration
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Tereza Rysava, Palacky University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
22 de junho de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2026
Conclusão do estudo (Estimado)
1 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
8 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de junho de 2026
Primeira postagem (Real)
12 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FTK_2026_14
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
All IPD that underlie results in a publication.
Prazo de Compartilhamento de IPD
Beginning 1 month after the publication of results with no end date.
Critérios de acesso de compartilhamento IPD
Anonymized IPD will be uploaded to an open-access data repository.
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