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

NCT ID: NCT06951789

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2025-07-31

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.

Conditions

Healthy; Respiratory Quotient Measurement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Molecular hydrogen

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

Group Type: EXPERIMENTAL

Molecular hydrogen

Intervention Type: OTHER

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Molecular hydrogen

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

Intervention Type: OTHER

Placebo

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

Intervention Type: OTHER

Other Intervention Names

i300 Hydrogen Generator, H2 World Health & Beauty Company, Ostrava, Czech Republic; i300 Hydrogen Generator (placebo), H2 World Health & Beauty Company, Ostrava, Czech Republic

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Palacky University

OTHER

Sponsor Role: lead

Responsible Party

Jakub Krejci

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Palacky University, Faculty of Physical Culture

Olomouc, Czech Republic, Czechia

Countries

Czechia

Other Identifiers

FTK_2024_101

Identifier Type: -

Identifier Source: org_study_id