- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05862987
The Effect of Hydrogen Rich Water Intake on Acute Body Response and Following Recovery After 5 km Run in Untrained Men
August 29, 2023 updated by: Jakub Krejci, Palacky University
The Effect of Hydrogen Rich Water Intake on Acute Body Response and Following Recovery After Single 5 km Run in Endurance-untrained Men. Randomized, Double Blinded, Placebo Controlled, Cross-over Study
The aim of this randomized, double blinded, placebo controlled cross-over study is to evaluate the effect of hydrogen rich water intake on running performance, physiological and biochemical variables during endurance exercise and following recovery in endurance-untrained men.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study involves 16 endurance-untrained men aged 18-30 years.
All participants drink hydrogen rich water (HRW) or placebo during the two days before the experiment (total volume 2100 ml) and during the testing day (total volume 1680 ml).
All participants undergo one laboratory session (entry diagnostic) and two experimental sessions in the field with a washout period of 7 days.
In the two experimental sessions, participants receive HRW or placebo in a randomized order.
Each experimental session consisted of a pre-exercise phase, an exercise phase (5 km run), and a 24 h passive recovery phase.
The following variables are assessed: running times (5 km distance and 200 m laps), heart rate, rating of perceived exertion, blood lactate, reactive strength index, subjective perceived muscle soreness, protein carbonyl content, malondialdehyde content, heart rate variability.
Statistical analysis is based on analysis of variance for repeated measures with the factors water (HRW and placebo), time, and interaction.
Fisher´s post hoc tests is used for pairwise comparison.
The significance level is set at 0.05.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Olomouc, Czechia, 77111
- Palacky University, Faculty of Physical Culture
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- No experience with endurance training.
- Good health condition.
- Signed informed content.
Exclusion Criteria:
- Acute health problems.
- Not following instructions (free of any supplements three weeks before experiment, free of any medicaments, no caffeine at least 24 hours before experiment).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hydrogen rich water
Hydrogen rich water supplied in 420 ml packages.
Two days before testing - 2 packages (morning and evening), one day before testing - 3 packages (morning, afternoon, and evening), testing day - 4 packages (2 h before the run, 1 h before the run, immediately after the run, and 1 h after the run), 9 packages in total.
|
Hydrogen-rich water with molecular hydrogen concentration 0.9 ppm.
Other Names:
|
|
Placebo Comparator: Placebo
Tap water supplied in 420 ml packages.
Two days before testing - 2 packages (morning and evening), one day before testing - 3 packages (morning, afternoon, and evening), testing day - 4 packages (2 h before the run, 1 h before the run, immediately after the run, and 1 h after the run), 9 packages in total.
|
Tap water with molecular hydrogen concentration 0.0 ppm.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Run time
Time Frame: Change between values before and after 7 days of crossover.
|
The 5 km run is performed on a 200 m long indoor track.
The running time (total time and laps times) of each runner is measured by one qualified timekeeper, which does not change between trials.
The time is measured to the nearest 0.1 s with manual stopwatch.
|
Change between values before and after 7 days of crossover.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate during running
Time Frame: Change between values before and after 7 days of crossover.
|
Heart rate during the 5 km run is continuously recorded using a heart rate monitor (Polar Team Coach, Polar, Kempele, Finland).
|
Change between values before and after 7 days of crossover.
|
|
Rating of perceived exertion
Time Frame: Change between values before and after 7 days of crossover.
|
The subject is asked to score subjective rating of perceived exertion using the scale developed by Borg.
All subjects are familiar with the Borg scale before testing.
We use the scale ranging from 6 (no exertion at all) to 20 (maximal exertion).
The rating of perceived exertion is scored immediately after the run.
|
Change between values before and after 7 days of crossover.
|
|
Blood lactate
Time Frame: Change between values before and after 7 days of crossover.
|
Blood lactate concentration is evaluated based on blood samples taken from the fingertip.
An alcohol wipe is used to clean the fingertip and the skin is punctured with a lancet.
The first drop is wiped away and the second drop is used.
Lactate Scout+ analyzer (EKF Diagnostics, Cardiff, United Kingdom) is used for lactate sampling.
Blood lactate is evaluated after the run.
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Change between values before and after 7 days of crossover.
|
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Reactive strength index
Time Frame: Change between values before and after 7 days of crossover.
|
Reactive strength index is determined in a 5 maximum hop test performed on a mobile force platform (FP8, HUR Labs, Tampere, Finland).
Each subject is instructed to maximize the jump height and minimize the ground contact time.
The first hop served as a countermovement jump and is excluded from the analysis.
The remaining 4 hops are averaged and reported as the outcome.
The reactive strength index is determined before and after the run, 1 h and 4 h after the run.
|
Change between values before and after 7 days of crossover.
|
|
Subjective perceived muscle soreness
Time Frame: Change between values before and after 7 days of crossover.
|
Visual analogue scale (VAS) is used to assess lower limb muscle soreness.
The VAS scale is a 100 mm long line marked with the numbers 0 (no pain) and 100 (worst imaginable pain).
The VAS is assessed immediately, 1 h, 4h, and 24 h after the run.
|
Change between values before and after 7 days of crossover.
|
|
Protein carbonyls
Time Frame: Change between values before and after 7 days of crossover.
|
Protein carbonyls are detected from vein blood sample which is taken from the inside of the elbow by a healthcare specialist.
The blood is taken into heparinized vacuum tubes.
These is then centrifugated at 1000 g.
Subsequently, the blood plasma is separated into cryotubes and frozen at -80 °C until biochemical analysis.
Protein carbonyls concentration is determined by ELISA method in accordance with the manufacturer´s manual (Protein Carbonyl Content Assay Kit MAK094, Sigma-Aldrich, Saint Louis, USA).
Protein carbonyls are sampled before and after the run, 1 h and 4 h after the run.
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Change between values before and after 7 days of crossover.
|
|
Malondialdehydes
Time Frame: Change between values before and after 7 days of crossover.
|
Malondialdehydes are detected from vein blood sample which is taken from the inside of the elbow by a healthcare specialist.
The blood is taken into heparinized vacuum tubes.
These is then centrifugated at 1000 g.
Subsequently, the blood plasma is separated into cryotubes and frozen at -80 °C until biochemical analysis.
The concentration of malondialdehydes in plasma samples as lipid peroxidation products is determined using the Lipid Peroxidation Assay Kit MAK085 (Sigma-Aldrich, Saint Louis, USA) according to the manufacturer's instructions.
Malondialdehydes are sampled before and after the run, 1 h and 4 h after the run.
|
Change between values before and after 7 days of crossover.
|
|
Heart rate variability - heart rate
Time Frame: Change between values before and after 7 days of crossover.
|
Heart rate (HR) is measured using the DiANS PF8 ECG device (DIMEA Group, Olomouc, Czech Republic).
ECG sampling is performed during an orthoclinostatic maneuver in a calm room without acoustic and visual disturbances.
HR is measured before and after the run, 1h and 4h after the run.
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Change between values before and after 7 days of crossover.
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Heart rate variability - RMSSD
Time Frame: Change between values before and after 7 days of crossover.
|
Root mean square successive difference of RR intervals (RMSSD) is measured using the DiANS PF8 ECG device (DIMEA Group, Olomouc, Czech Republic).
ECG sampling is performed during an orthoclinostatic maneuver in a calm room without acoustic and visual disturbances.
RMSSD is measured before and after the run, 1h and 4h after the run.
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Change between values before and after 7 days of crossover.
|
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Heart rate variability - SDNN
Time Frame: Change between values before and after 7 days of crossover.
|
Standard deviation of RR intervals (SDNN) is measured using the DiANS PF8 ECG device (DIMEA Group, Olomouc, Czech Republic).
ECG sampling is performed during an orthoclinostatic maneuver in a calm room without acoustic and visual disturbances.
SDNN is measured before and after the run, 1h and 4h after the run.
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Change between values before and after 7 days of crossover.
|
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Heart rate variability - LF/HF
Time Frame: Change between values before and after 7 days of crossover.
|
Ratio of low-frequency to high-frequency power (LF/HF) is measured using the DiANS PF8 ECG device (DIMEA Group, Olomouc, Czech Republic).
ECG sampling is performed during an orthoclinostatic maneuver in a calm room without acoustic and visual disturbances.
LF/HF is measured before and after the run, 1h and 4h after the run.
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Change between values before and after 7 days of crossover.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michal Valenta, Mgr, Palacky University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 22, 2023
Primary Completion (Actual)
August 29, 2023
Study Completion (Actual)
August 29, 2023
Study Registration Dates
First Submitted
May 4, 2023
First Submitted That Met QC Criteria
May 15, 2023
First Posted (Actual)
May 17, 2023
Study Record Updates
Last Update Posted (Actual)
August 30, 2023
Last Update Submitted That Met QC Criteria
August 29, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FTK_2023_14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymised raw data will be made available.
IPD Sharing Time Frame
The data will be available once the results are published in a scientific journal.
IPD Sharing Access Criteria
For everybody.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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