UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050872 |
|---|---|
| Receipt number | R000057964 |
| Scientific Title | Anti-fatigue effect of hydrogen water during exercise |
| Date of disclosure of the study information | 2023/04/19 |
| Last modified on | 2023/10/17 23:17:36 |
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Basic information
Public title
Anti-fatigue effect of hydrogen water during exercise
Acronym
Anti-fatigue effect of hydrogen water during exercise
Scientific Title
Anti-fatigue effect of hydrogen water during exercise
Scientific Title:Acronym
Anti-fatigue effect of hydrogen water during exercise
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investige the anti-fatigue effect of hydrogen water during exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in heart rate at the end of exercise compared to 10 minutes after the exercise start
Key secondary outcomes
(1) Heart rate, oxygen uptake, carbon dioxide excretion, blood lactate, thigh muscle oxygen saturation/blood flow, and perceived exercise intensity during constant-load exercise
(2) Heart rate variability before and after exercise
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A total of three exercise tests will be performed. First, an incremental exercise test using a gas analyzer will be performed to determine the aerobic threshold. Next, the subjects will drink hydrogenated water and exercise using a bicycle under a constant load. Additionally, they drink non-hydrogenated water and exercise in the same method.
Interventions/Control_2
A total of three exercise tests will be performed. First, an incremental exercise test using a gas analyzer will be performed to determine the aerobic threshold. Next, the subjects will drink non-hydrogenated water and exercise using a bicycle under a constant load. Additionally, they drink hydrogenated water and exercise in the same method.
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 subjects aged 18-60
2.Those who verbally responded that they have the ability to continue moderate-intensity exercise (exercise intensity of 115% of the anaerobic metabolic threshold) for 30 minutes
Key exclusion criteria
1.Those who are judged to be inappropriate for this research by the research director/co-investigator
2.Those who cannot exercise enough due to trauma or disability
3.Those who take medicine on a daily basis
4.Those with dementia or mental illness who cannot understand the significance of this study
Target sample size
50
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
ITO EN Co., Ltd.
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
| 2023 | Year | 04 | Month | 19 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 04 | Month | 17 | Day |
Last modified on
| 2023 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057964
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| Registered date | File name |
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| Registered date | File name |
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