HealthyNCT06951789
Effect of Molecular Hydrogen Inhalation on Metabolic Response During Low-intensity Exercise on a Bicycle Ergometer
A study testing Molecular hydrogen in people with Healthy and Respiratory Quotient Measurement, run by Palacky University at 1 site in Czechia.
Trial summary
This trial evaluates the effect of molecular hydrogen inhalation on metabolic response, heart rate, and rating of perceived exertion in healthy females during 30 minutes of exercise on a bicycle ergometer. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Respiratory Quotient Measurement
- What is being tested?
- Molecular hydrogen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 5 May 2025to 19 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Free of major diseases.
- Signed informed consent.
Who cannot join
- Acute conditions contraindicating laboratory testing of exercise.
- Cardiorespiratory disease.
- Pharmacotherapy affecting metabolism.
- Musculoskeletal problems.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Palacky University, Faculty of Physical Culture
Olomouc, Czech Republic, 77111
About this study
Official title: Effect of Molecular Hydrogen Inhalation on Metabolic Response in Healthy Females During Low-intensity Exercise on a Bicycle Ergometer: A Randomized, Double-blind, Placebo-controlled Crossover Trial
This trial evaluates the effect of molecular hydrogen inhalation on metabolic response, heart rate, and rating of perceived exertion in healthy females during 30 minutes of exercise on a bicycle ergometer.
Read the detailed description
The objective of this randomized, double-blind, placebo-controlled crossover trial is to assess the effect of molecular hydrogen inhalation on metabolic response during 20 min of rest and during exercise on a bicycle ergometer with a workload of 0.5 W/kg for 10 min, 0.75 W/kg for 10 min, and 1 W/kg for 10 min. The trial recruits healthy females aged 20-35 years and the planned sample size is 20. The trial consists of two experimental sessions, one using molecular hydrogen inhalation and the other using placebo inhalation. The washout period between sessions is one week. Randomization of the order of the sessions is performed using a computer random generator. Molecular hydrogen is produced using a hydrogen generator via electrolysis of water and administered through a mouthpiece. Ambient air is used for placebo inhalation. Molecular hydrogen is colorless, odorless, and tasteless, making it indistinguishable from placebo by the human senses. During the session, the following variables are measured: ventilation, oxygen uptake, respiratory exchange ratio, heart rate, rating of perceived exertion, and oxygen saturation. Energy expenditure, fat oxidation rate and carbohydrates oxidation rate are calculated from oxygen uptake and respiratory exchange ratio. Statistical analysis is performed at the 0.05 significance level and data are evaluated using analysis of variance for repeated measures with Fisher's post hoc tests.
- Conditions
- Healthy, Respiratory Quotient Measurement
- Being tested
- Molecular hydrogen, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular hydrogenOther
Also called i300 Hydrogen Generator, H2 World Health & Beauty Company, Ostrava, Czech Republic
Hydrogen gas, purity >99.9%, flow rate 600 ml/min (two generators 300 ml/min each).
PlaceboOther
Also called i300 Hydrogen Generator (placebo), H2 World Health & Beauty Company, Ostrava, Czech Republic
Ambient air, flow rate 600 ml/min (two pumps 300 ml/min each).
| Study group | Role | What they receive |
|---|---|---|
| Molecular hydrogen | Experimental | Molecular hydrogen inhalation for 20 min at rest and 30 min during exercise. Receives: Other: Molecular hydrogen |
| Placebo | Placebo comparator | Placebo inhalation for 20 min at rest and 30 min during exercise. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory exchange ratio
Respiratory exchange ratio is measured with Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the session and averaged over 5 min windows for subsequent analysis.
Measured: Change after 1 week of crossover.
Secondary outcomes (4)
Ventilation
Ventilation is measured with Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the session and averaged over 5 min windows for subsequent analysis.
Measured: Change after 1 week of crossover.
Oxygen uptake
Oxygen uptake is measured with Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the session and averaged over 5 min windows for subsequent analysis.
Measured: Change after 1 week of crossover.
Heart rate
Heart rate is recorded by Polar H10 chest strap (Polar, Kempele, Finland) during the session and averaged over 5 min windows for subsequent analysis.
Measured: Change after 1 week of crossover.
Rating of perceived exertion
Participants are asked to subjectively rate their perceived exertion at specified time points (at the end of rest, after 10, 20, and 30 min of exercise). The Borg's scale 6 (no exertion) and 20 (maximal exertion) is used.
Measured: Change after 1 week of crossover.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start5 May 2025
- Primary completion19 Jun 2026
- Study completion19 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palacky University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakub Krejci, Palacky University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951789
- Sponsor's protocol ID
- FTK_2024_101
- Status last verified
- Jun 2026
- First submitted
- 23 Apr 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Molecular Hydrogen Inhalation on Metabolic Response in Healthy Females During Low-intensity Exercise on a Bicycle Ergometer: A Randomized, Double-blind, Placebo-controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT06951789
- Acronym / sponsor ID
- FTK_2024_101
- Conditions
- Healthy, Respiratory Quotient Measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Palacky UniversityUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 19 Jun 2026 (actual)
- Study completion
- 19 Jun 2026 (actual)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial evaluates the effect of molecular hydrogen inhalation on metabolic response, heart rate, and rating of perceived exertion in healthy females during 30 minutes of exercise on a bicycle ergometer.
Detailed description
The objective of this randomized, double-blind, placebo-controlled crossover trial is to assess the effect of molecular hydrogen inhalation on metabolic response during 20 min of rest and during exercise on a bicycle ergometer with a workload of 0.5 W/kg for 10 min, 0.75 W/kg for 10 min, and 1 W/kg for 10 min. The trial recruits healthy females aged 20-35 years and the planned sample size is 20. The trial consists of two experimental sessions, one using molecular hydrogen inhalation and the other using placebo inhalation. The washout period between sessions is one week. Randomization of the order of the sessions is performed using a computer random generator. Molecular hydrogen is produced using a hydrogen generator via electrolysis of water and administered through a mouthpiece. Ambient air is used for placebo inhalation. Molecular hydrogen is colorless, odorless, and tasteless, making it indistinguishable from placebo by the human senses. During the session, the following variables are measured: ventilation, oxygen uptake, respiratory exchange ratio, heart rate, rating of perceived exertion, and oxygen saturation. Energy expenditure, fat oxidation rate and carbohydrates oxidation rate are calculated from oxygen uptake and respiratory exchange ratio. Statistical analysis is performed at the 0.05 significance level and data are evaluated using analysis of variance for repeated measures with Fisher's post hoc tests.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Molecular hydrogen | Experimental | Other: Molecular hydrogenMolecular hydrogen inhalation for 20 min at rest and 30 min during exercise. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo inhalation for 20 min at rest and 30 min during exercise. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Free of major diseases.
- Signed informed consent.
Key exclusion criteria (4 listed)
- Acute conditions contraindicating laboratory testing of exercise.
- Cardiorespiratory disease.
- Pharmacotherapy affecting metabolism.
- Musculoskeletal problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular hydrogenAlso: i300 Hydrogen Generator, H2 World Health & Beauty Company, Ostrava, Czech RepublicHydrogen gas, purity >99.9%, flow rate 600 ml/min (two generators 300 ml/min each). | Other | Molecular hydrogen |
| PlaceboAlso: i300 Hydrogen Generator (placebo), H2 World Health & Beauty Company, Ostrava, Czech RepublicAmbient air, flow rate 600 ml/min (two pumps 300 ml/min each). | Other | Placebo |
Primary outcome
Respiratory exchange ratio
Time frame: Change after 1 week of crossover.
Respiratory exchange ratio is measured with Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the session and averaged over 5 min windows for subsequent analysis.
4 secondary outcomes
Ventilation
Time frame: Change after 1 week of crossover.
Oxygen uptake
Time frame: Change after 1 week of crossover.
Heart rate
Time frame: Change after 1 week of crossover.
Rating of perceived exertion
Time frame: Change after 1 week of crossover.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molecular hydrogen in people with Healthy and Respiratory Quotient Measurement, run by Palacky University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory exchange ratio (time frame: Change after 1 week of crossover.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.