NCT03846141

Brief Summary

In this randomized double-blind, placebo-controlled, crossover pilot trial, we evaluated the effects of 7-day H2 inhalation on exercise performance outcomes and serum hormonal and inflammation profiles in a cohort of young men and women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

February 17, 2019

Last Update Submit

February 18, 2019

Conditions

Exercise Performance

Outcome Measures

Primary Outcomes (1)

  • Change in exercise performance

    Running time-to-exhaustion

    Change from baseline running time-to-exhaustion at 7 days

Secondary Outcomes (3)

  • Change in exercise performance

    Change from baseline maximal voluntary isometric strength at 7 days

  • Change in clinical chemistry biomarker

    Change from baseline serum insulin at 7 days

  • Change in clinical chemistry biomarker

    Change from baseline serum ghrelin at 7 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Room air for inhalation

Other: Placebo

Hydrogen

EXPERIMENTAL

Hydrogen (4%) for inhalation

Other: Hydrogen

Interventions

PlaceboOTHER

Inhalation of room air for 20 min per day during 7 days

Placebo
HydrogenOTHER

Inhalation of 4% hydrogen for 20 min per day during 7 days

Hydrogen

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥ 18 -35 years Body mass index 20 - 25 kg/m2 Free of major diseases Physically active Must be able to give written informed consent

You may not qualify if:

  • Use of any dietary supplements within 4 weeks before study commences Abnormal values for lab clinical chemistry (\> 2 SD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FSPE Applied Bioenergetics Lab

Novi Sad, Vojvodina, 21000, Serbia

Location

Related Publications (4)

  • Aoki K, Nakao A, Adachi T, Matsui Y, Miyakawa S. Pilot study: Effects of drinking hydrogen-rich water on muscle fatigue caused by acute exercise in elite athletes. Med Gas Res. 2012 Jul 12;2:12. doi: 10.1186/2045-9912-2-12. eCollection 2012.

    PMID: 22520831BACKGROUND

  • Ostojic SM. Serum alkalinization and hydrogen-rich water in healthy men. Mayo Clin Proc. 2012 May;87(5):501-2. doi: 10.1016/j.mayocp.2012.02.008. No abstract available.

    PMID: 22560529BACKGROUND

  • Da Ponte A, Giovanelli N, Nigris D, Lazzer S. Effects of hydrogen rich water on prolonged intermittent exercise. J Sports Med Phys Fitness. 2018 May;58(5):612-621. doi: 10.23736/S0022-4707.17.06883-9. Epub 2017 Apr 26.

    PMID: 28474871BACKGROUND

  • Javorac D, Stajer V, Ratgeber L, Betlehem J, Ostojic S. Short-term H2 inhalation improves running performance and torso strength in healthy adults. Biol Sport. 2019 Dec;36(4):333-339. doi: 10.5114/biolsport.2019.88756. Epub 2019 Oct 31.

    PMID: 31938004DERIVED

MeSH Terms

Interventions

Hydrogen

Intervention Hierarchy (Ancestors)

ElementsInorganic ChemicalsGases

Study Officials

  • Sergej Ostojic, MD, PhD

    University of Novi Sad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2019

First Posted

February 19, 2019

Study Start

January 15, 2018

Primary Completion

June 15, 2018

Study Completion

September 15, 2018

Last Updated

February 20, 2019

Record last verified: 2019-02

Locations

SE(1)