Clinical trial NCT06951789: Effect of Molecular Hydrogen Inhalation on Metabolic Response During Low-intensity Exercise on a Bicycle Ergometer
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy
Respiratory Quotient Measurement
Lead sponsor: Palacky University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Respiratory exchange ratio
timeFrame: Change after 1 week of crossover.
Secondary outcomes:
measure: Ventilation
timeFrame: Change after 1 week of crossover.
measure: Oxygen uptake
timeFrame: Change after 1 week of crossover.
measure: Heart rate
timeFrame: Change after 1 week of crossover.
measure: Rating of perceived exertion
timeFrame: Change after 1 week of crossover.
Other outcomes:
measure: Oxygen saturation
timeFrame: Change after 1 week of crossover.
Locations:
city: Olomouc
country: Czech Republic
facility: Palacky University, Faculty of Physical Culture
Study officials:
References: