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

Oxidative Stress Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05862987
• Other study ID #: FTK_2023_14
• Status: Completed
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: August 29, 2023

Study information

• Verified date: August 2023
• Source: Palacky University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 29, 2023
• Est. primary completion date: August 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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).

Related Conditions & MeSH terms

• Athletic Performance
• Fatigue
• Muscle Fatigue
• Oxidative Stress

Intervention

Dietary Supplement:
• Hydrogen rich water
Hydrogen-rich water with molecular hydrogen concentration 0.9 ppm.
• Placebo
Tap water with molecular hydrogen concentration 0.0 ppm.

Locations

Country	Name	City	State
Czechia	Palacky University, Faculty of Physical Culture	Olomouc

Sponsors (1)

Lead Sponsor	Collaborator
Palacky University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change between values before and after 7 days of crossover.
Secondary	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).	Change between values before and after 7 days of crossover.
Secondary	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.	Change between values before and after 7 days of crossover.
Secondary	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.	Change between values before and after 7 days of crossover.
Secondary	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.	Change between values before and after 7 days of crossover.
Secondary	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.	Change between values before and after 7 days of crossover.
Secondary	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.	Change between values before and after 7 days of crossover.
Secondary	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.	Change between values before and after 7 days of crossover.
Secondary	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.	Change between values before and after 7 days of crossover.
Secondary	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.	Change between values before and after 7 days of crossover.
Secondary	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.	Change between values before and after 7 days of crossover.
Secondary	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.	Change between values before and after 7 days of crossover.