UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052257 |
|---|---|
| Receipt number | R000059655 |
| Scientific Title | Effects of ice slurry ingestion during endurance exercise on thermoregulatory function and indices of fatigue |
| Date of disclosure of the study information | 2023/09/20 |
| Last modified on | 2023/09/20 18:48:00 |
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Basic information
Public title
Effects of ice slurry ingestion during endurance exercise on thermoregulatory function and indices of fatigue
Acronym
Effects of ice slurry ingestion during exercise on thermoregulatory function and indices of fatigue
Scientific Title
Effects of ice slurry ingestion during endurance exercise on thermoregulatory function and indices of fatigue
Scientific Title:Acronym
Effects of ice slurry ingestion during exercise on thermoregulatory function and indices of fatigue
Region
| Japan |
Condition
Condition
healthy male university students
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examined the effects of ice slurry ingestion during endurance exercise on thermoregulatory function and indices of fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eight healthy male university students were asked to consume 5 g of ice slurry or sports drink per kilogram of body weight 30 min after the starting a 60-min period of treadmill running.
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
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Eight healthy male university students were asked to consume 5 g of ice slurry per kilogram of body weight 30 min after the starting a 60-min period of treadmill running.
Interventions/Control_2
Eight healthy male university students were asked to consume 5 g of sports drink per kilogram of body weight 30 min after the starting a 60-min period of treadmill running.
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
| 22 | years-old | > |
Gender
Male
Key inclusion criteria
healthy male university students
Key exclusion criteria
Persons who have developed a medical or surgical condition as a result of endurance exercise loading or blood sampling in the past
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Nishimura |
Organization
Nihon Fukushi University
Division name
Department of Sport Scienses
Zip code
470-3295
Address
35-6, Egemae, Okuda, Mihama-cho, Chita-gun, Aichi
TEL
0569872211
nnaoki@n-fukushi.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Nishimura |
Organization
Nihon Fukushi University
Division name
Department of Sport Scienses
Zip code
470-3295
Address
35-6, Egemae, Okuda, Mihama-cho, Chita-gun, Aichi
TEL
0569872211
Homepage URL
nnaoki@n-fukushi.ac.jp
Sponsor or person
Institute
Nihon Fukushi University
Institute
Department
Personal name
Funding Source
Organization
Nihon Fukushi University
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
Nihon Fukushi University
Address
35-6, Egemae, Okuda, Mihama-cho, Chita-gun, Aichi
Tel
0569872211
nnaoki@n-fukushi.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 | 09 | 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
9
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
| 2022 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2024 | 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 | 09 | Month | 20 | Day |
Last modified on
| 2023 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059655
