Clinical trial NCT03846141: Hydrogen Inhalation for Health and Exercise Performance
Official title: Hydrogen Inhalation for Health and Exercise Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Performance
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Detailed description: All participants were allocated to receive either gaseous hydrogen (4%) or placebo (room air) by 20-min once-per-day inhalation for 7 days, with wash-out period of 7 days to prevent the residual effects of interventions across study periods. The primary treatment outcome was the change in running time-to-exhaustion from baseline to day 7. Additionally, assessment of other exercise performance endpoints and clinical chemistry biomarkers were performed at baseline and after 7 days after each intervention.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in exercise performance
timeFrame: Change from baseline running time-to-exhaustion at 7 days
Secondary outcomes:
measure: Change in exercise performance
timeFrame: Change from baseline maximal voluntary isometric strength at 7 days
measure: Change in clinical chemistry biomarker
timeFrame: Change from baseline serum insulin at 7 days
measure: Change in clinical chemistry biomarker
timeFrame: Change from baseline serum ghrelin at 7 days
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: FSPE Applied Bioenergetics Lab
state: Vojvodina
Study officials:
affiliation: University of Novi Sad
name: Sergej Ostojic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.