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

Primary Purpose

Athletic Performance, Muscle Fatigue, Oxidative Stress

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Hydrogen rich water
Placebo
Sponsored by
Palacky University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Athletic Performance

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Palacky University, Faculty of Physical Culture

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydrogen rich water

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 4, 2023
Last Updated
August 29, 2023
Sponsor
Palacky University
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1. Study Identification

Unique Protocol Identification Number
NCT05862987
Brief Title
The Effect of Hydrogen Rich Water Intake on Acute Body Response and Following Recovery After 5 km Run in Untrained Men
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
August 29, 2023 (Actual)
Study Completion Date
August 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palacky University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Athletic Performance, Muscle Fatigue, Oxidative Stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Visually indistinguishable packages of hydrogen rich water and placebo.
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrogen rich water
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydrogen rich water
Other Intervention Name(s)
Aquastamina-R, Nutristamina, Ostrava, Czech Republic
Intervention Description
Hydrogen-rich water with molecular hydrogen concentration 0.9 ppm.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Aquastamina-Placebo, Nutristamina, Ostrava, Czech Republic
Intervention Description
Tap water with molecular hydrogen concentration 0.0 ppm.
Primary Outcome Measure Information:
Title
Run time
Description
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.
Time Frame
Change between values before and after 7 days of crossover.
Secondary Outcome Measure Information:
Title
Heart rate during running
Description
Heart rate during the 5 km run is continuously recorded using a heart rate monitor (Polar Team Coach, Polar, Kempele, Finland).
Time Frame
Change between values before and after 7 days of crossover.
Title
Rating of perceived exertion
Description
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.
Time Frame
Change between values before and after 7 days of crossover.
Title
Blood lactate
Description
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.
Time Frame
Change between values before and after 7 days of crossover.
Title
Reactive strength index
Description
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.
Time Frame
Change between values before and after 7 days of crossover.
Title
Subjective perceived muscle soreness
Description
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.
Time Frame
Change between values before and after 7 days of crossover.
Title
Protein carbonyls
Description
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.
Time Frame
Change between values before and after 7 days of crossover.
Title
Malondialdehydes
Description
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.
Time Frame
Change between values before and after 7 days of crossover.
Title
Heart rate variability - heart rate
Description
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.
Time Frame
Change between values before and after 7 days of crossover.
Title
Heart rate variability - RMSSD
Description
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.
Time Frame
Change between values before and after 7 days of crossover.
Title
Heart rate variability - SDNN
Description
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.
Time Frame
Change between values before and after 7 days of crossover.
Title
Heart rate variability - LF/HF
Description
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.
Time Frame
Change between values before and after 7 days of crossover.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Valenta, Mgr
Organizational Affiliation
Palacky University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palacky University, Faculty of Physical Culture
City
Olomouc
ZIP/Postal Code
77111
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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