UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052776 |
|---|---|
| Receipt number | R000060212 |
| Scientific Title | Effects and mechanisms of high-oxygen water on exercise tolerance |
| Date of disclosure of the study information | 2023/11/13 |
| Last modified on | 2023/11/15 11:35:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects and mechanisms of high-oxygen water on exercise tolerance
Acronym
Effects and mechanisms of high-oxygen water on exercise tolerance
Scientific Title
Effects and mechanisms of high-oxygen water on exercise tolerance
Scientific Title:Acronym
Effects and mechanisms of high-oxygen water on exercise tolerance
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study was to verify what kind of biological reactions occur during an exercise stress test in drinking high-oxygen water.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Load amount at anaerobic metabolic threshold in progressive exercise stress test
Key secondary outcomes
Heart rate, oxygen intake, respiratory rate, blood oxygen saturation, femoral oxygen saturation, and exercise load at the symptomatic limit during an incremental exercise stress test
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
The subjects were instructed to drink 500 ml of high-oxygen water for about 2 minutes each time, three times in total: the night before, 1.5 hours before the day of the study, and immediately before the study. After that, perform progressive load exercise using a bicycle (first time). Repeat these steps after 7 days or more (second time).
Interventions/Control_2
Subjects are instructed to drink 500 ml of normal drinking water (non-oxygenated water) for about 2 minutes each time, three times in total: the night before, 1.5 hours before the day of the study, and immediately before the study. After that, perform progressive load exercise using a bicycle (first time). Repeat these steps after 7 days or more (second time).
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. Persons with no medical history
2.Subjects who answered that they were able to perform a progressive exercise load test.
Key exclusion criteria
1. Those who are judged by the principal investigator or co-investigator to be unsuitable as subjects for this study
2. Persons who are unable to exercise sufficiently due to injury or disability
3. Those who take medication on a daily basis
4. Those who are unable to understand the significance of this study due to dementia or mental illness.
Target sample size
20
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
Sigma Technology 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 | 11 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 28 | 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 | 11 | Month | 12 | Day |
Last modified on
| 2023 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060212
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
