Hydrogen Inhalation for Health and Exercise Performance (HIHEP)

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.

Study Overview

• Status: Completed
• Conditions: Exercise Performance
• Intervention / Treatment: Other: Placebo; Other: Hydrogen

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Serbia
  • Vojvodina
    • Novi Sad, Vojvodina, Serbia, 21000
      • FSPE Applied Bioenergetics Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Room air for inhalation	Other: Placebo; Inhalation of room air for 20 min per day during 7 days
Experimental: Hydrogen; Hydrogen (4%) for inhalation	Other: Hydrogen; Inhalation of 4% hydrogen for 20 min per day during 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in exercise performance	Running time-to-exhaustion	Change from baseline running time-to-exhaustion at 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in exercise performance	Maximal voluntary isometric strength	Change from baseline maximal voluntary isometric strength at 7 days
Change in clinical chemistry biomarker	Insulin	Change from baseline serum insulin at 7 days
Change in clinical chemistry biomarker	Ghrelin	Change from baseline serum ghrelin at 7 days

Collaborators and Investigators

• Sponsor: University of Novi Sad, Faculty of Sport and Physical Education
• Investigators: Principal Investigator: Sergej Ostojic, MD, PhD, University of Novi Sad

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): June 15, 2018
• Study Completion (Actual): September 15, 2018

Study Registration Dates

• First Submitted: February 17, 2019
• First Submitted That Met QC Criteria: February 17, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 18, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: UniversityNSFSandPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will provide IPD on our University repository site

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No