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

NCT05982665 | Completed

• 1 other identifier: FTK_2023_12
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle Soreness; Muscle Fatigue; Oxidative Stress; Inflammation

Outcome Measures

Primary Outcomes (2)

• Creatine kinase

  The level of creatine kinase is measured from a venous blood sample taken by a healthcare specialist. Samples are collected in 2.7 ml citrate vacuum tubes. Samples are immediately centrifuged at 1000 g for 15 min and then divided into 0.5 ml cryotubes and frozen at -80 °C. Samples are taken pre-exercise (baseline), post-exercise, and 2 h, 24 h and 48 h post-exercise. Creatine kinase is determined by ELISA method according to the manufacturer's instructions.

  Change between values before and after 4 weeks of crossover.

• Perceived muscle soreness

  A visual analogue scale is used to subjectively assess lower limb muscle soreness. The visual analogue scale is represented by a 100 mm line marked 0 - no pain and 100 - worst imaginable pain. The subject is instructed to mark a point on the line corresponding to their perceived muscle soreness. Muscle soreness is assessed pre-exercise (baseline), post-exercise, and 2 h, 24 h and 48 h post-exercise.

  Change between values before and after 4 weeks of crossover.

Secondary Outcomes (3)

• Reactive strength index

  Change between values before and after 4 weeks of crossover.

• Malondialdehydes

  Change between values before and after 4 weeks of crossover.

• Interleukin-6

  Change between values before and after 4 weeks of crossover.

Other Outcomes (5)

• Heart rate

  Change between values before and after 4 weeks of crossover.

• Ventilation

  Change between values before and after 4 weeks of crossover.

• Oxygen uptake

  Change between values before and after 4 weeks of crossover.

Study Arms (2)

Molecular hydrogen

EXPERIMENTAL

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.

Other: Molecular hydrogen

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Molecular hydrogen OTHER

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

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

Molecular hydrogen

Placebo OTHER

Ambient air, flow rate 300 ml/min.

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

Placebo

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Acute conditions contraindicating laboratory testing of sports performance.
• Hypertension.
• Dyslipoproteinaemia.
• Cardiorespiratory disease.
• Pharmacotherapy affecting heart rate.
• Musculoskeletal problems.

Sponsors & Collaborators

• Palacky University: lead

Study Sites (1)

Palacky University, Faculty of Physical Culture

Olomouc, 77111, Czechia

Location

MeSH Terms

Conditions

Myalgia; Inflammation

Interventions

Hydrogen

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Elements; Inorganic Chemicals; Gases

Study Officials

• Adam Jarmar, Mgr

  Palacky University, Faculty of Physical Culture

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Hydrogen and placebo generators indistinguishable to the human senses
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 8, 2023
• Study Start: August 14, 2023
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be available once the results are published in a scientific journal.
• Access Criteria: For everybody.

Locations

CZ (1)