UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058083 |
|---|---|
| Receipt number | R000066331 |
| Scientific Title | Investivation of the anti-fatigue effect of hydrogen gas inhalation during exercise |
| Date of disclosure of the study information | 2025/06/05 |
| Last modified on | 2025/06/04 23:11:04 |
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Basic information
Public title
Investivation of the anti-fatigue effect of hydrogen gas inhalation during exercise
Acronym
Investivation of the anti-fatigue effect of hydrogen gas inhalation during exercise
Scientific Title
Investivation of the anti-fatigue effect of hydrogen gas inhalation during exercise
Scientific Title:Acronym
Investivation of the anti-fatigue effect of hydrogen gas inhalation during exercise
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to clarify the anti-fatigue effects of hydrogen gas inhalation during exercise
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum oxygen intake during exercise.
Key secondary outcomes
Comparison of heart rate, blood lactate, oxygen intake, thigh muscle oxygen saturation, perceived exertion, heart rate variability analysis during standing exercise, salivary IgA, and blood proteomics during constant load exercise
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Constant load exercise for 30 minutes in a hydrogen gas inhalation
Interventions/Control_2
Constant load exercise for 30 minutes in a non-hydrogen gas inhalation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy individuals aged 18-60 years old
2. Those who have exercise habits or not, but who verbally respond that they can continue moderate-intensity exercise for 30 minutes
Key exclusion criteria
1. Those who the principal investigator or co-investigator judges to be inappropriate to be subjects of this study
2. Those who are unable to exercise sufficiently due to injuries or disabilities
3. Those who regularly take medication other than for allergies, insomnia, or anxiety
4. Those who have used hydrogen products within the past week at the time of obtaining consent
5. Those who plan to use hydrogen products after obtaining consent until the end of the study
6. Those who are unable to understand the significance of this study due to dementia or psychiatric disorders
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Katsumata |
| Middle name | |
| Last name | Yoshinori |
Organization
Keio University
Division name
School of Medicine, Institute for Integrated Sports Medicine
Zip code
160-0016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
03-5269-9054
goodcentury21@keio.jp
Public contact
Name of contact person
| 1st name | Katsumata |
| Middle name | |
| Last name | Yoshinori |
Organization
Keio University
Division name
School of Medicine, Institute for Integrated Sports Medicine
Zip code
160-0016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
03-5269-9054
Homepage URL
goodcentury21@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Kotobiken Medical Laboratories, Inc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 04 | Day |
Last modified on
| 2025 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066331
