UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054156 |
|---|---|
| Receipt number | R000061843 |
| Scientific Title | Effects of muscle mass on physiological and performance responses to ice slurry ingestion with a cooling vest in the heat |
| Date of disclosure of the study information | 2024/04/16 |
| Last modified on | 2024/04/15 16:17:48 |
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Basic information
Public title
Effects of muscle mass on physiological and performance responses to ice slurry ingestion with a cooling vest in the heat
Acronym
Muscle mass and mixed-method body cooling
Scientific Title
Effects of muscle mass on physiological and performance responses to ice slurry ingestion with a cooling vest in the heat
Scientific Title:Acronym
Muscle mass and mixed-method body cooling
Region
| Japan |
Condition
Condition
Moderate hyperthermia
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing the effect of ice slurry ingestion with a cooling vest on rectal temperature and cycling time-trial performance between males with different muscle masses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rectal temperature and cycling time-trial performance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Other |
Interventions/Control_1
5.0 g per body mass of fluid ingestion
Interventions/Control_2
5.0 g per body mass of ice slurry ingestion with a cooling vest
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy individuals with exercise habits
Key exclusion criteria
Humans who do not meet the inclusion criteria
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Yanaoka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
7398524
Address
1-1-1, kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
TEL
0824246846
yanaoka@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Yanaoka |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
7398524
Address
1-1-1, kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
TEL
0824246846
Homepage URL
yanaoka@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Board in the Graduate School of Humanities and Social Sciences
Address
1-1-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima
Tel
+81-82-424-6705
ed-ken-zai@office.hiroshima-u.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
| 2024 | Year | 04 | Month | 16 | Day |
Related information
URL releasing protocol
https://yanaokalab.hiroshima-u.ac.jp/
Publication of results
Unpublished
Result
URL related to results and publications
https://yanaokalab.hiroshima-u.ac.jp/
Number of participants that the trial has enrolled
16
Results
Reductions in rectal temperature during the break and second half were observed in the High group, but not the Low group. In the High group, COOL mitigated the decline in mean power output during the second time-trial relative to the first time-trial.
Results date posted
| 2024 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
As per the inclusion criteria
Participant flow
In a randomized and counterbalanced crossover design, 16 males completed two 30-min cycling bouts comprising a 25-min cycling at 55% of maximal oxygen uptake followed by a 5-min time-trial in the heat. The bouts were separated by a 15-min break. During the break, participants were assigned to control trial (CON: 5.0 g of fluid ingestion) or cool trial (COOL: 5.0 g of ice slurry ingestion with a cooling vest).
Adverse events
No
Outcome measures
rectal temperature and cycling time-trial performance
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2021 | 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
| 2024 | Year | 04 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061843
