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Clinical Trials/NCT06951789
NCT06951789CompletedNot Applicable

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

Palacky University1 site in 1 country20 target enrollmentStarted: May 5, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Respiratory exchange ratio

Study Overview

Brief 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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Molecular hydrogen

Experimental

Molecular hydrogen inhalation for 20 min at rest and 30 min during exercise.

Intervention: Molecular hydrogen (Other)

Placebo

Placebo Comparator

Placebo inhalation for 20 min at rest and 30 min during exercise.

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Oxygen uptake(Change after 1 week of crossover.)
  • Ventilation(Change after 1 week of crossover.)
  • Heart rate(Change after 1 week of crossover.)
  • Rating of perceived exertion(Change after 1 week of crossover.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jakub Krejci

Assistant professor

Palacky University

Study Sites (1)

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