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Athletic PerformanceNCT05862987

The Effect of Hydrogen Rich Water Intake on Acute Body Response and Following Recovery After 5 km Run in Untrained Men

A study testing Hydrogen rich water in people with Athletic Performance and Muscle Fatigue, run by Palacky University at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 30 years, men onlyHealthy volunteers can take part
What is being tested?
Hydrogen rich water
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteCzechia
Study dates
22 May 2023to 29 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • No experience with endurance training.
  • Good health condition.
  • Signed informed content.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • Palacky University, Faculty of Physical Culture

    Olomouc, 77111

Other trials in Czechia

About this study

Official title: 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.

Read the 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.

Being tested
Hydrogen rich water, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydrogen rich waterDietary supplement

    Also called Aquastamina-R, Nutristamina, Ostrava, Czech Republic

    Hydrogen-rich water with molecular hydrogen concentration 0.9 ppm.

  • PlaceboDietary supplement

    Also called Aquastamina-Placebo, Nutristamina, Ostrava, Czech Republic

    Tap water with molecular hydrogen concentration 0.0 ppm.

Study groups in NCT05862987
Study groupRoleWhat they receive
Hydrogen rich waterExperimentalHydrogen 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.
Receives: Dietary Supplement: Hydrogen rich water
PlaceboPlacebo comparatorTap 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.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Run time

    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.

    Measured: Change between values before and after 7 days of crossover.

Secondary outcomes (11)

  1. Heart rate during running

    Heart rate during the 5 km run is continuously recorded using a heart rate monitor (Polar Team Coach, Polar, Kempele, Finland).

    Measured: Change between values before and after 7 days of crossover.

  2. Rating of perceived exertion

    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.

    Measured: Change between values before and after 7 days of crossover.

  3. Blood lactate

    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.

    Measured: Change between values before and after 7 days of crossover.

  4. Reactive strength index

    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.

    Measured: Change between values before and after 7 days of crossover.

  5. Subjective perceived muscle soreness

    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.

    Measured: Change between values before and after 7 days of crossover.

  6. Protein carbonyls

    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.

    Measured: Change between values before and after 7 days of crossover.

  7. Malondialdehydes

    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.

    Measured: Change between values before and after 7 days of crossover.

  8. Heart rate variability - heart rate

    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.

    Measured: Change between values before and after 7 days of crossover.

  9. Heart rate variability - RMSSD

    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.

    Measured: Change between values before and after 7 days of crossover.

  10. Heart rate variability - SDNN

    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.

    Measured: Change between values before and after 7 days of crossover.

  11. Heart rate variability - LF/HF

    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.

    Measured: Change between values before and after 7 days of crossover.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2023
  2. Study start22 May 2023
  3. Primary completion29 Aug 2023
  4. Study completion29 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05862987
Sponsor's protocol ID
FTK_2023_14
Status last verified
Aug 2023
First submitted
4 May 2023
Last updated
30 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymised raw data will be made available.

Questions about this trial

What is this clinical trial studying?

A study testing Hydrogen rich water in people with Athletic Performance and Muscle Fatigue, run by Palacky University at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Run time (time frame: Change between values before and after 7 days of crossover.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05862987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.

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