UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055618 |
|---|---|
| Receipt number | R000063560 |
| Scientific Title | Exploratory intervention study on food intake in the growing age group |
| Date of disclosure of the study information | 2024/09/25 |
| Last modified on | 2025/09/25 10:09:57 |
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Basic information
Public title
Exploratory intervention study on food intake in the growing age group
Acronym
Exploratory intervention study on food intake in the growing age group
Scientific Title
Exploratory intervention study on food intake in the growing age group
Scientific Title:Acronym
Exploratory intervention study on food intake in the growing age group
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of 8 weeks of intake of fermented milk protein on exercise performance and cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise performance
(1) Rebound jump
(2) Counter movement jump
(3) Standing long jump
(4) 20 m sprint
(5) Yo-Yo test
Key secondary outcomes
(1) Gut microbiota
(2) Cognitive test
(3) Height, weight and sitting height
(4) Body composition
(5) Sleep status evaluation
(6) Nutrition survey
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the study food 1(8 weeks)
Interventions/Control_2
Oral intake of the study food 2(8 weeks)
Interventions/Control_3
Oral intake of the placebo study food(8 weeks)
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
Key inclusion criteria
Children who play soccer at least once a week.
Key exclusion criteria
1) Children who have difficulty undergoing the same physical fitness tests as able-bodied individuals due to physical, intellectual or mental disabilities.
2) Children who are not medically permitted to fully participate in sports or exercise due to illnesses such as heart disease.
3) Children whose health may be adversely affected by ingesting the test foods due to allergies, lactose intolerance, etc.
Target sample size
45
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
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
102-0085
Address
5-5 Rokubancho, Chiyoda, Tokyo
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
Euphoria Co., Ltd
Address
5-5 Rokubancho, Chiyoda, Tokyo
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
| 2024 | Year | 09 | Month | 25 | 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
44
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 02 | Month | 21 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 25 | Day |
Last modified on
| 2025 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063560
