UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058461 |
|---|---|
| Receipt number | R000066837 |
| Scientific Title | Verification of the effects of continuous consumption of test meals on heatstroke-related items in male junior high school soccer players |
| Date of disclosure of the study information | 2025/07/18 |
| Last modified on | 2025/07/14 16:42:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Verification of the effects of continuous consumption of test meals on heatstroke-related items in male junior high school soccer players
Acronym
Verification of the effects of continuous consumption of test meals on heatstroke-related items in male junior high school soccer players
Scientific Title
Verification of the effects of continuous consumption of test meals on heatstroke-related items in male junior high school soccer players
Scientific Title:Acronym
Verification of the effects of continuous consumption of test meals on heatstroke-related items in male junior high school soccer players
Region
| Japan |
Condition
Condition
Not available
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effects of continuous consumption of test foods on heatstroke-related items.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
melatonin secretion level
Key secondary outcomes
Urine 3-methoxy-4-hydroxyphenylglycol
Vanillylmandelic acid
Salivary glucose level
Urine C-peptide
Subjective sleep assessment
Presence or absence of heat exhaustion-related symptoms
Presence or absence of heatstroke
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
test meal
Interventions/Control_2
placebo test food
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
| 13 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male junior high school soccer players
Players who regularly participate in games and practice
Key exclusion criteria
Those who have abnormalities detected during health checkups or other examinations, or who are unable to participate in team practices or games during the study period
Those who do not consume medications, supplements, or foods that may affect blood sugar or sleep
Others deemed unsuitable as research subjects by the principal investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Nagashima |
Organization
Musashigaoka Junior College
Division name
Department of Health Science
Zip code
355-0154
Address
111-1 Minami-Yoshimi, Yoshimi-machi, Hiki-gun, Saitama Prefecture
TEL
0493545101
nagashima-y@musashigaoka.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Nagashima |
Organization
Musashigaoka Junior College
Division name
Department of Health and Life Sciences
Zip code
3550154
Address
111-1, Minami Yoshimi, Yoshimi-Town, Hiki-Gun, Saitama
TEL
0493545101
Homepage URL
nagashima-y@musashigaoka.ac.jp
Sponsor or person
Institute
Musashigaoka Junior College
Institute
Department
Personal name
Yosuke Nagashima
Funding Source
Organization
Bourbon Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Rikkyo University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Musashigaoka Junior College
Address
111-1, Minami Yoshimi, Yoshimi-Town, Hiki-Gun, Saitama Pref.
Tel
0493545101
info@musashigaoka.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
武蔵丘短期大学（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066837
