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Effect of Inhaled Molecular Hydrogen on Recovery Process After Downhill Walking on the Treadmill

NCT ID: NCT05982665

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-14

Study Completion Date

2023-11-29

Brief Summary

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This study assesses the effect of molecular hydrogen inhalation in healthy males on muscle soreness, fatigue, oxidative stress, and inflammation following eccentric muscle contraction during downhill walking on the treadmill.

Detailed Description

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The main aim of this randomized, double-blind, placebo-controlled crossover study is to assess the effect of molecular hydrogen inhalation on recovery after downhill walking with an additional load of 15% of body mass on the treadmill with a negative slope of -15% at a speed of 6.5 km/h for 90 min. The study includes 12 participants, healthy males aged 20-35 years. The study consists of two experimental sessions, one using molecular hydrogen inhalation and the other using placebo inhalation. Randomization is performed using a computer random generator. Molecular hydrogen is colourless, odourless, and tasteless, so it cannot be distinguished from placebo by the human senses. The washout period between sessions is set at four weeks. One week before each session, participants are asked to follow diet and physical activity rules. Variables measured during the 48 h recovery are as follow: creatine kinase level, perceived muscle soreness, reactive strength index, malondialdehydes level, and interleukin-6 level. The following variables are also measured during exercise: heart rate, ventilation and gas exchange, and blood lactate level. Analysis of variance for repeated measures and Fisher's post hoc tests are used for statistical analysis. The significance level is set at 0.05.

Conditions

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Muscle Soreness Muscle Fatigue Oxidative Stress Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Hydrogen and placebo generators indistinguishable to the human senses

Study Groups

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Molecular hydrogen

Molecular hydrogen inhalation for 60 min at 48 h, 24 h, and 60 min pre-exercise and for 30 min post-exercise and 24 h post exercise.

Group Type EXPERIMENTAL

Molecular hydrogen

Intervention Type OTHER

Hydrogen gas, purity \>99.9%, flow rate 300 ml/min.

Placebo

Placebo inhalation for 60 min at 48 h, 24 h, and 60 min pre-exercise and for 30 min post-exercise and 24 h post exercise.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Ambient air, flow rate 300 ml/min.

Interventions

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Molecular hydrogen

Hydrogen gas, purity \>99.9%, flow rate 300 ml/min.

Intervention Type OTHER

Placebo

Ambient air, flow rate 300 ml/min.

Intervention Type OTHER

Other Intervention Names

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i300 Hydrogen Generator, H2 World Health & Beauty Company, Ostrava, Czech Republic i300 Placebo Generator, H2 World Health & Beauty Company, Ostrava, Czech Republic

Eligibility Criteria

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Inclusion Criteria

* Free of major diseases.
* Completed questionnaire Sudden Cardiovascular Death in Sport: Lausanne Recommendations.
* Signed informed consent.

Exclusion Criteria

* Acute conditions contraindicating laboratory testing of sports performance.
* Hypertension.
* Dyslipoproteinaemia.
* Cardiorespiratory disease.
* Pharmacotherapy affecting heart rate.
* Musculoskeletal problems.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Palacky University

OTHER

Sponsor Role lead

Responsible Party

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Jakub Krejci

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam Jarmar, Mgr

Role: PRINCIPAL_INVESTIGATOR

Palacky University, Faculty of Physical Culture

Locations

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Palacky University, Faculty of Physical Culture

Olomouc, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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FTK_2023_12

Identifier Type: -

Identifier Source: org_study_id