UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060162 |
|---|---|
| Receipt number | R000068806 |
| Scientific Title | Research on the energy balance of athletes in the development stage |
| Date of disclosure of the study information | 2025/12/22 |
| Last modified on | 2025/12/22 16:48:01 |
* 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
Research on the energy balance of athletes in the development stage
Acronym
Research on the energy balance of athletes in the development stage
Scientific Title
Research on the energy balance of athletes in the development stage
Scientific Title:Acronym
Research on the energy balance of athletes in the development stage
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the actual state of energy balance in developing Japanese athletes
Basic objectives2
Others
Basic objectives -Others
Fact-finding survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Energy balance (energy intake - energy expenditure) assessed by questionnaires
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 10 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Male and female aged 10 to 12 years.
2. Participants who meet one of the following criteria:
- Exercise group: Engage in extracurricular sports activities at least twice a week.
- Non-exercise group: Do not engage in regular extracurricular sports activities.
3. Ability to measure body weight at home.
4. Access to a personal computer at home to complete the activity log.
Key exclusion criteria
1. Participants who are not medically permitted to participate in sports or exercise due to pre-existing conditions such as heart disease.
2. Participants whose exercise and lifestyle habits on the survey days differ from their usual routine due to poor health, injury, or other reasons.
3. Participants who engage in regular physical activities other than sports (excluding school curriculum activities).
4. Participants who have difficulty providing accurate answers to the surveys due to mental illness or other reasons.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kanda |
Organization
Meiji Co., Ltd.
Division name
Nutrition Development Research Unit. R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo 192-0919, JAPAN
TEL
080-8131-5912
atsushi.kanda.ba@meiji.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Urushizawa |
Organization
Euphoria Co., Ltd
Division name
Data Management Group
Zip code
102-0083
Address
Kojimachi Crystal City East Bldg. 10F, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo 102-0083, JAPAN
TEL
080-3321-0048
Homepage URL
sdm@eu-phoria.jp
Sponsor or person
Institute
Euphoria Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review 110 Board of Euphoria Co., Ltd.
Address
Kojimachi Crystal City East Bldg. 10F, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo 102-0083, JAPAN
Tel
080-3321-0048
Team-rd@eu-phoria.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
| 2025 | Year | 12 | Month | 22 | 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 | 12 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 23 | 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
This is a non-interventional, observational study.
Management information
Registered date
| 2025 | Year | 12 | Month | 22 | Day |
Last modified on
| 2025 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068806
