Effect of Pre-exercise Inhalation of Molecular Hydrogen on Metabolic Response During Graded Exercise in Healthy Women
22 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
22
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Tereza Rysava
- Numéro de téléphone: +420585636154
- E-mail: tereza.rysava01@upol.cz
Sauvegarde des contacts de l'étude
- Nom: Jakub Krejci, PhD
- E-mail: jakub.krejci@upol.cz
Lieux d'étude
-
-
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Olomouc, Tchéquie, 77111
- Recrutement
- Palacky University, Faculty of Physical Culture
-
Contact:
- Tereza Rysava
- Numéro de téléphone: +420585636154
- E-mail: tereza.rysava01@upol.cz
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Molecular hydrogen
Molecular hydrogen inhalation for 60 minutes daily for 7 days.
|
Gas mixture containing 3.75% molecular hydrogen and ambient air.
Autres noms:
|
|
Comparateur placebo: Placebo
Ambient air inhalation for 60 minutes daily for 7 days.
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Ambient air without molecular hydrogen.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Respiratory exchange ratio
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Oxygen uptake
Délai: 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
Délai: 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.
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Change after 2 weeks of crossover.
|
|
Minute ventilation
Délai: 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
Délai: 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
Délai: 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.
|
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Blood lactate concentration
Délai: 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
Délai: 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.
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Blood glucose concentration
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Tereza Rysava, Palacky University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
22 juin 2026
Achèvement primaire (Estimé)
1 décembre 2026
Achèvement de l'étude (Estimé)
1 décembre 2026
Dates d'inscription aux études
Première soumission
8 juin 2026
Première soumission répondant aux critères de contrôle qualité
8 juin 2026
Première publication (Réel)
12 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FTK_2026_14
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
All IPD that underlie results in a publication.
Délai de partage IPD
Beginning 1 month after the publication of results with no end date.
Critères d'accès au partage IPD
Anonymized IPD will be uploaded to an open-access data repository.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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