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Recruiting NCT07644000

Effect of Pre-exercise Inhalation of Molecular Hydrogen on Metabolic Response During Graded Exercise in Healthy Women

No phase Interventional Healthy Adult Females

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Molecular hydrogen, Placebo.
Who it may be relevant to
Registry conditions: Healthy Adult Females. Basic parameters: 18 years — 30 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other Molecular hydrogen
    Gas mixture containing 3.75% molecular hydrogen and ambient air.
  • Other Placebo
    Ambient air without molecular hydrogen.

Primary outcome measures

  • Respiratory exchange ratio [Time frame: Change after 2 weeks of crossover.]
Secondary outcome measures (7)
  • Oxygen uptake [Time frame: Change after 2 weeks of crossover.]
  • Carbon dioxide production [Time frame: Change after 2 weeks of crossover.]
  • Minute ventilation [Time frame: Change after 2 weeks of crossover.]
  • Breathing frequency [Time frame: Change after 2 weeks of crossover.]
  • Heart rate [Time frame: Change after 2 weeks of crossover.]
  • Blood lactate concentration [Time frame: Change after 2 weeks of crossover.]
  • Rating of perceived exertion [Time frame: Change after 2 weeks of crossover.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

Czechia · 1 center
  • Palacky University, Faculty of Physical Culture — Olomouc

Identifiers

NCT: NCT07644000 · FTK_2026_14

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗