UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039272 |
|---|---|
| Receipt number | R000044792 |
| Scientific Title | Effects of ice slurry ingestion on tympanic temperature during exercise |
| Date of disclosure of the study information | 2020/02/03 |
| Last modified on | 2020/07/28 17:06:38 |
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Basic information
Public title
Effects of ice slurry ingestion on tympanic temperature during exercise
Acronym
Effects of ice slurry ingestion on tympanic temperature during exercise
Scientific Title
Effects of ice slurry ingestion on tympanic temperature during exercise
Scientific Title:Acronym
Effects of ice slurry ingestion on tympanic temperature during exercise
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of ice slurry ingestion on tympanic temperature and cycling performance in college rugby football players during high-intensity intermittent exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Continuous measurement of tympanic temperature
Key secondary outcomes
Temporal artery temperature, Subjective fatigue parameters (VAS) etc
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of ice slurry.
Interventions/Control_2
Single ingestion of room temperature ice slurry.
Interventions/Control_3
Single ingestion of room temperature water.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) Healthy male
2) College rugby players
Key exclusion criteria
1) Subjects who have a disease
2) Subjects who have a serious disease history
3) Subjects who are judged as unsuitable for the study by the principal investigator etc
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Naohiko |
| Middle name | |
| Last name | Kohtake |
Organization
Keio University
Division name
Graduate School of System Design and Management
Zip code
223-0061
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
TEL
045-564-2580
kohtake@sdm.keio.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Hirata |
Organization
Keio University
Division name
Graduate School of System Design and Management
Zip code
223-0061
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
TEL
045-564-2580
Homepage URL
akihiro.hirata@sdm.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
TAISHO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
TAISHO PHARMACEUTICAL CO., LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Sports Medicine Research Center, Keio University
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
Tel
045-566-1090
rxb03102@nifty.com
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
慶應義塾大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 03 | 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
18
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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 27 | Day |
Last modified on
| 2020 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044792
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
