NCT06951789

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

May 5, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 8, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

April 23, 2025

Last Update Submit

May 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change after 1 week of crossover.

Secondary Outcomes (4)

  • Ventilation

    Change after 1 week of crossover.

  • Oxygen uptake

    Change after 1 week of crossover.

  • Heart rate

    Change after 1 week of crossover.

  • Rating of perceived exertion

    Change after 1 week of crossover.

Other Outcomes (1)

  • Oxygen saturation

    Change after 1 week of crossover.

Study Arms (2)

Molecular hydrogen

EXPERIMENTAL

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

Other: Molecular hydrogen

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Hydrogen gas, purity \>99.9%, flow rate 600 ml/min (two generators 300 ml/min each).

Also known as: i300 Hydrogen Generator, H2 World Health & Beauty Company, Ostrava, Czech Republic
Molecular hydrogen
PlaceboOTHER

Ambient air, flow rate 600 ml/min (two pumps 300 ml/min each).

Also known as: i300 Hydrogen Generator (placebo), H2 World Health & Beauty Company, Ostrava, Czech Republic
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Free of major diseases.
  • Signed informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palacky University, Faculty of Physical Culture

Olomouc, Czech Republic, 77111, Czechia

Location

MeSH Terms

Interventions

Hydrogen

Intervention Hierarchy (Ancestors)

ElementsInorganic ChemicalsGases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 23, 2025

First Posted

April 30, 2025

Study Start

May 5, 2025

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

May 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication.

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

Locations