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NCT03846141 Clinical Trial

Hydrogen Inhalation for Health and Exercise Performance

Exercise Performance Clinical Trial

— HIHEP  

Official title:
Hydrogen Inhalation for Health and Exercise Performance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03846141
Other study ID # UniversityNSFSandPE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2018
Est. completion date September 15, 2018

Study information
Verified date February 2019
Source University of Novi Sad, Faculty of Sport and Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 15, 2018
Est. primary completion date June 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Placebo
Inhalation of room air for 20 min per day during 7 days
• Hydrogen
Inhalation of 4% hydrogen for 20 min per day during 7 days

Locations
Country Name City State
Serbia FSPE Applied Bioenergetics Lab Novi Sad Vojvodina

Sponsors (1)
Lead Sponsor Collaborator
University of Novi Sad, Faculty of Sport and Physical Education

Country where clinical trial is conducted

Serbia, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in exercise performance Running time-to-exhaustion Change from baseline running time-to-exhaustion at 7 days
Secondary Change in exercise performance Maximal voluntary isometric strength Change from baseline maximal voluntary isometric strength at 7 days
Secondary Change in clinical chemistry biomarker Insulin Change from baseline serum insulin at 7 days
Secondary Change in clinical chemistry biomarker Ghrelin Change from baseline serum ghrelin at 7 days
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