UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059998 |
|---|---|
| Receipt number | R000051116 |
| Scientific Title | Investigation on the effect of different amount of ice slurry intakes on performance and core temperature of high school long distance runners. |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2025/12/05 15:32:47 |
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Basic information
Public title
Investigation on the effect of different amount of ice slurry intakes on performance and core temperature of high school long distance runners.
Acronym
The effect of ice slurry on performance and core temperature of high school long distance runners.
Scientific Title
Investigation on the effect of different amount of ice slurry intakes on performance and core temperature of high school long distance runners.
Scientific Title:Acronym
The effect of ice slurry on performance and core temperature of high school long distance runners.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to determine a difference in amount of ice slurry consumption on performance and core temperature among high school long distance runners. In addition, the study also examines changes in physical condition that may influence performance by consuming different amount of ice slurry.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in core temperature as determined from a drum temperature between the baseline and sessions instructed participants to consume different amount of ice slurry.
Key secondary outcomes
Differences in 1) time of 3,000 m run, 2) a number of calculation tests answered and a percentage of correct answers, and 3) differences in physical conditions between the baseline and sessions instructed participants to consume different amount of ice slurry.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Investigate effects of consuming different amount of ice slurry. After baseline assessment, participants will be instructed to consume 100 g ice slurry at the first intervention session. At the second intervention, participants were instructed to consume 7.5 g of ice slurry per kg body weight.
Interventions/Control_2
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
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A member of high school athletic squad who participated an information session and obtained consent from both student and their guardians.
Key exclusion criteria
a) those who did not participate a baseline assessment session, b) those with injury and illness, and c) absent from assessment sessions and having missing data.
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Masaharu |
| Middle name | |
| Last name | Kagawa |
Organization
Kagawa Nutrition University
Division name
Institute of Nutrition Sciences
Zip code
350-0288
Address
3-9-21 Chiyoda, Sakado, Saitama
TEL
049-281-7743
mskagawa@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Masaharu |
| Middle name | |
| Last name | Kagawa |
Organization
Kagawa Nutrition University
Division name
Institute of Nutrition Sciences
Zip code
350-0288
Address
3-9-21 Chiyoda, Sakado, Saitama
TEL
049-281-7743
Homepage URL
mskagawa@eiyo.ac.jp
Sponsor or person
Institute
Institute of Nutrition Sciences,
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
Institute of Nutrition Sciences,
Kagawa Nutrition University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa Nutrition University
Address
3-9-21 Chiyoda, Sakado, Saitama
Tel
049-281-7743
mskagawa@eiyo.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
女子栄養大学栄養科学研究所(埼玉県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Results are not published
Number of participants that the trial has enrolled
17
Results
Compared to the second day when one pack was consumed, on the third day when ice slurry was consumed at a target rate of 7.5g per kg of body weight, the difference in core temperature between post-warm-up and post-ice slurry intake was significantly lower (p<0.01). Questionnaires showed that participants felt significantly less heat (p<0.05) on day 3 compared to day 2, and their 3,000m time was 12 seconds faster (p<0.05). The response and correct rates decreased on day 3.
Results date posted
| 2025 | Year | 12 | Month | 05 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Because the data entry process had stalled midway.
Date of the first journal publication of results
Baseline Characteristics
16 males and 1 female participants with average height and body mass of 169.0 cm and 53.6 kg.
Participant flow
Participants were those who provided informed consent to participate in the study after receiving an explanation of the research, obtained from both the participants themselves and their legal guardian. Participants first completed a baseline survey, followed by two interventions differing in the amount and method of ice slurry consumed.
Adverse events
On the day of the trial which participants consumed 7.5g/kg body mass of ice slurry in a single dose, 11 out of 17 participants reported physical changes such as stomach discomfort, abdominal bloating, and abdominal coldness.
Outcome measures
1) Tympanic membrane temperature
2) 3,000m time trial
3) Concentration test
4) Questionnaire
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051116
