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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Molecular hydrogen | Experimental | Molecular hydrogen inhalation for 60 minutes daily for 7 days. |
|
| Placebo | Placebo Comparator | Ambient air inhalation for 60 minutes daily for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molecular hydrogen | Other | Gas mixture containing 3.75% molecular hydrogen and ambient air. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory exchange ratio | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen uptake | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose concentration | 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. |
Inclusion Criteria:
Exclusion Criteria:
Cisgender women.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tereza Rysava | Contact | +420585636154 | tereza.rysava01@upol.cz | |
| Jakub Krejci, PhD | Contact | jakub.krejci@upol.cz |
| Name | Affiliation | Role |
|---|---|---|
| Tereza Rysava | Palacky University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palacky University, Faculty of Physical Culture | Recruiting | Olomouc | 77111 | Czechia |
All IPD that underlie results in a publication.
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Beginning 1 month after the publication of results with no end date.
Anonymized IPD will be uploaded to an open-access data repository.
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| ID | Term |
|---|---|
| D006859 | Hydrogen |
| ID | Term |
|---|---|
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Placebo | Other | Ambient air without molecular hydrogen. |
|
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 | 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 | 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 | 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 | 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 | 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. |