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Hydrogen Inhalation for Health and Exercise Performance (HIHEP)

Primary Purpose

Exercise Performance

Status
Completed
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Placebo
Hydrogen
Sponsored by
University of Novi Sad, Faculty of Sport and Physical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Exercise Performance

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • FSPE Applied Bioenergetics Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Hydrogen

Arm Description

Room air for inhalation

Hydrogen (4%) for inhalation

Outcomes

Primary Outcome Measures

Change in exercise performance
Running time-to-exhaustion

Secondary Outcome Measures

Change in exercise performance
Maximal voluntary isometric strength
Change in clinical chemistry biomarker
Insulin
Change in clinical chemistry biomarker
Ghrelin

Full Information

First Posted
February 17, 2019
Last Updated
February 18, 2019
Sponsor
University of Novi Sad, Faculty of Sport and Physical Education
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1. Study Identification

Unique Protocol Identification Number
NCT03846141
Brief Title
Hydrogen Inhalation for Health and Exercise Performance
Acronym
HIHEP
Official Title
Hydrogen Inhalation for Health and Exercise Performance
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
June 15, 2018 (Actual)
Study Completion Date
September 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Novi Sad, Faculty of Sport and Physical Education

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Performance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Room air for inhalation
Arm Title
Hydrogen
Arm Type
Experimental
Arm Description
Hydrogen (4%) for inhalation
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Inhalation of room air for 20 min per day during 7 days
Intervention Type
Other
Intervention Name(s)
Hydrogen
Intervention Description
Inhalation of 4% hydrogen for 20 min per day during 7 days
Primary Outcome Measure Information:
Title
Change in exercise performance
Description
Running time-to-exhaustion
Time Frame
Change from baseline running time-to-exhaustion at 7 days
Secondary Outcome Measure Information:
Title
Change in exercise performance
Description
Maximal voluntary isometric strength
Time Frame
Change from baseline maximal voluntary isometric strength at 7 days
Title
Change in clinical chemistry biomarker
Description
Insulin
Time Frame
Change from baseline serum insulin at 7 days
Title
Change in clinical chemistry biomarker
Description
Ghrelin
Time Frame
Change from baseline serum ghrelin at 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergej Ostojic, MD, PhD
Organizational Affiliation
University of Novi Sad
Official's Role
Principal Investigator
Facility Information:
Facility Name
FSPE Applied Bioenergetics Lab
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We will provide IPD on our University repository site
Citations:
PubMed Identifier
22520831
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.
Results Reference
background
PubMed Identifier
22560529
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.
Results Reference
background
PubMed Identifier
28474871
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.
Results Reference
background
PubMed Identifier
31938004
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.
Results Reference
derived

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Hydrogen Inhalation for Health and Exercise Performance

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