NCT05799911

Brief Summary

The aim of this randomized, double-blind, placebo-controlled crossover trial is to evaluate the effect of hydrogen-rich water consumption on performance, recovery, psychological and biochemical outcomes in elite Czech fin-swimmers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 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

March 10, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

April 11, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

March 10, 2023

Last Update Submit

May 6, 2024

Conditions

Athletic PerformanceMuscle FatigueOxidative Stress

Outcome Measures

Primary Outcomes (1)

  • Swimming time for 400 m

    Swimming time is recorded according to swimming and fin-swimming rules. Swimming time is measured by two qualified timekeepers. The longer time is the official time.

    Change between values before and after 7 days of crossover.

Secondary Outcomes (8)

  • Swimming time for 50 m

    Change between values before and after 7 days of crossover.

  • Heart rate variability

    Change between values before and after 7 days of crossover.

  • Lower limb explosive strength

    Change between values before and after 7 days of crossover.

  • Rating of perceived exertion

    Change between values before and after 7 days of crossover.

  • Subjective perceived muscle soreness

    Change between values before and after 7 days of crossover.

  • +3 more secondary outcomes

Study Arms (2)

Molecular hydrogen

EXPERIMENTAL

Hydrogen-rich water supplied in 420-ml packages. 3 days before testing day - 3 packages per day, testing day - 6 packages, 15 packages in total.

Dietary Supplement: Hydrogen rich water

Placebo

PLACEBO COMPARATOR

Tap water supplied in 420-ml packages. 3 days before testing day - 3 packages per day, testing day - 6 packages, 15 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
Molecular hydrogen
PlaceboDIETARY_SUPPLEMENT

Tap water with molecular hydrogen concentration 0.0 ppm.

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

Eligibility Criteria

Age16 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Junior or adult Czech fin-swimming representative.
  • Medical eligibility for competitive sport.
  • Good health condition.
  • Signed informed consent.

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).
  • Menstruation in testing session.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palacky University, Faculty of Physical Culture

Olomouc, 77111, Czechia

Location

Related Publications (2)

  • Botek M, Krejčí J, Sládečková B, McKune A. Autonomic cardiac regulation in response to exercise and molecular hydrogen administration in well-trained athletes. In: Slezak J, Kura B, eds. Molecular Hydrogen in Health and Disease. Springer Nature Switzerland; 2024:69-91. doi:10.1007/978-3-031-47375-3_5

    RESULT

  • Sladeckova B, Botek M, Krejci J, Valenta M, McKune A, Neuls F, Klimesova I. Hydrogen-rich water supplementation promotes muscle recovery after two strenuous training sessions performed on the same day in elite fin swimmers: randomized, double-blind, placebo-controlled, crossover trial. Front Physiol. 2024 Apr 12;15:1321160. doi: 10.3389/fphys.2024.1321160. eCollection 2024.

    PMID: 38681143RESULT

Study Officials

  • Barbora Sladeckova, MSc

    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

March 10, 2023

First Posted

April 5, 2023

Study Start

April 11, 2023

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

May 8, 2024

Record last verified: 2024-05

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)