UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051242 |
|---|---|
| Receipt number | R000058437 |
| Scientific Title | Physiological effects highly concentrated fine bubble water with oxygen-infused during high-altitude mountain climbing and high-intensity exercise |
| Date of disclosure of the study information | 2023/06/20 |
| Last modified on | 2023/12/01 09:05:08 |
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Basic information
Public title
Physiological effects highly concentrated fine bubble water with oxygen-infused during high-altitude mountain climbing and high-intensity exercise
Acronym
Physiological effects of highly concentrated fine bubble water with oxygen-infused
Scientific Title
Physiological effects highly concentrated fine bubble water with oxygen-infused during high-altitude mountain climbing and high-intensity exercise
Scientific Title:Acronym
Physiological effects of highly concentrated fine bubble water with oxygen-infused
Region
| Japan |
Condition
Condition
Able-bodied person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Therefore, we will examine the physiological changes, including SpO2, caused by drinking oxygen-infused, highly concentrated UFB water during high-altitude mountain climbing and high-intensity exercise, and explore how to utilize these changes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Saturation(SpO2)
Key secondary outcomes
Lake Louise Score, Blood pressure, Urinary ketones, Salivary stress markers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The intervention group will be asked to drink oxygen-infused high-concentration UFB water before, during, and after high-altitude mountain climbing and high-intensity exercise test activities, and various measurements will be made.
Interventions/Control_2
The control group is asked to drink normal water before, during, and after the activities of the high-altitude mountain climbing and high-intensity exercise stress test, and various measurements are performed.
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
| 16 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students who belong to an athletic club in a Japanese high school.
Key exclusion criteria
The participants are not eligible to participate in the survey if they: (a) can not walk without instruments (T-cane, crutch, wheelchair etc...); (b) have some sort of injury so as to hinder exercise at the time of the survey.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ohtsuki |
Organization
Suzuka University of Medical Science
Division name
Department of Clinical Nutrition
Zip code
5100293
Address
1001-1 Kishioka Suzuka Mie
TEL
0593838991
ohtsukim@suzuka-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ohtsuki |
Organization
Suzuka University of Medical Science
Division name
Department of Clinical Nutrition
Zip code
510-0293
Address
1001-1 Kishioka Suzuka Mie
TEL
0593838991
Homepage URL
ohtsukim@suzuka-u.ac.jp
Sponsor or person
Institute
Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Rinnai Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Tsu City College
Address
15 Issinden Tsu Mie
Tel
059-232-2341
aikawa@tsu-cc.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 | 06 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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 | 06 | Month | 02 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058437
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
