Effect of Molecular Hydrogen Inhalation on Metabolic Response During Low-intensity Exercise on a Bicycle Ergometer

May 5, 2025 updated by: Jakub Krejci, Palacky University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Olomouc, Czech Republic, 77111
        • Palacky University, Faculty of Physical Culture

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Free of major diseases.
  • Signed informed consent.

Exclusion Criteria:

  • Acute conditions contraindicating laboratory testing of exercise.
  • Cardiorespiratory disease.
  • Pharmacotherapy affecting metabolism.
  • Musculoskeletal problems.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Molecular hydrogen
Molecular hydrogen inhalation for 20 min at rest and 30 min during exercise.
Other: Molecular hydrogen
Hydrogen gas, purity >99.9%, flow rate 600 ml/min (two generators 300 ml/min each).
Other Names:
  • i300 Hydrogen Generator, H2 World Health & Beauty Company, Ostrava, Czech Republic
Placebo Comparator: Placebo
Placebo inhalation for 20 min at rest and 30 min during exercise.
Other: Placebo
Ambient air, flow rate 600 ml/min (two pumps 300 ml/min each).
Other Names:
  • i300 Hydrogen Generator (placebo), H2 World Health & Beauty Company, Ostrava, Czech Republic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change after 1 week of crossover.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilation
Time Frame: Change after 1 week of crossover.
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.
Change after 1 week of crossover.
Oxygen uptake
Time Frame: Change after 1 week of crossover.
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.
Change after 1 week of crossover.
Heart rate
Time Frame: Change after 1 week of crossover.
Heart rate is recorded by Polar H10 chest strap (Polar, Kempele, Finland) during the session and averaged over 5 min windows for subsequent analysis.
Change after 1 week of crossover.
Rating of perceived exertion
Time Frame: Change after 1 week of crossover.
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.
Change after 1 week of crossover.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen saturation
Time Frame: Change after 1 week of crossover.
Oxygen saturation is measured with pulse oximeter (Onyx Vantage 9590, Nonin Medical, Plymouth, MN) at specified time points (every 5 min at rest and every 2,5 min during exercise).
Change after 1 week of crossover.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palacky University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

April 23, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FTK_2024_101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication.

IPD Sharing Time Frame

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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