NCT05862987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

May 22, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

May 4, 2023

Last Update Submit

August 29, 2023

Conditions

Athletic PerformanceMuscle FatigueOxidative Stress

Outcome Measures

Primary Outcomes (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.

    Change between values before and after 7 days of crossover.

Secondary Outcomes (11)

  • Heart rate during running

    Change between values before and after 7 days of crossover.

  • Rating of perceived exertion

    Change between values before and after 7 days of crossover.

  • Blood lactate

    Change between values before and after 7 days of crossover.

  • Reactive strength index

    Change between values before and after 7 days of crossover.

  • Subjective perceived muscle soreness

    Change between values before and after 7 days of crossover.

  • +6 more secondary outcomes

Study Arms (2)

Hydrogen rich water

EXPERIMENTAL

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.

Dietary Supplement: Hydrogen rich water

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Hydrogen rich waterDIETARY_SUPPLEMENT

Hydrogen-rich water with molecular hydrogen concentration 0.9 ppm.

Also known as: Aquastamina-R, Nutristamina, Ostrava, Czech Republic
Hydrogen rich water
PlaceboDIETARY_SUPPLEMENT

Tap water with molecular hydrogen concentration 0.0 ppm.

Also known as: Aquastamina-Placebo, Nutristamina, Ostrava, Czech Republic
Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palacky University, Faculty of Physical Culture

Olomouc, 77111, Czechia

Location

Study Officials

  • Michal Valenta, Mgr

    Palacky University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Visually indistinguishable packages of hydrogen rich water and placebo.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Palacky University, Faculty of Physical Culture

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 17, 2023

Study Start

May 22, 2023

Primary Completion

August 29, 2023

Study Completion

August 29, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

Anonymised raw data will be made available.

Time Frame
The data will be available once the results are published in a scientific journal.
Access Criteria
For everybody.

Locations

CZ(1)