UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052369 |
|---|---|
| Receipt number | R000059784 |
| Scientific Title | Study to investigate vegetable intake of elementary and junior high school students and their parents: An observational study |
| Date of disclosure of the study information | 2023/10/02 |
| Last modified on | 2024/08/29 16:44:16 |
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Basic information
Public title
Study to investigate vegetable intake of elementary and junior high school students and their parents
Acronym
Study to investigate vegetable intake of elementary and junior high school students and their parents
Scientific Title
Study to investigate vegetable intake of elementary and junior high school students and their parents: An observational study
Scientific Title:Acronym
Study to investigate vegetable intake of elementary and junior high school students and their parents
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To assess skin carotenoid level of elementary and junior high school students
2. To assess the difference of skin carotenoid level of the students and their parents
Basic objectives2
Others
Basic objectives -Others
An observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Skin carotenoid level of the students (children) and their parents
Key secondary outcomes
- Body height and body weight of children
- Frequency of vegetable intake of children
- Health condition of children
- Frequency with which the children eat a meal other than that provided by the parents
- Characteristic and attribute of children and the parents
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
| 6 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Males and females between 6 and 15 years of age (elementary and junior high schoolers) and their parents (no age limit) at the time consent to participate in the study is obtained
2) Children who can be accompanied by their parents (daily meal providers) on the designated examination day and who are eligible for the examination.
3) Those who reside in the following area; Tokyo, Saitama, Chiba, Kanagawa, Kyoto, Osaka, Shiga, Hyogo, Nara, Wakayama, Aichi, Gifu, and Mie
4) Those who have been fully informed of the purpose and content of this study, whose parents are able to consent to participation in this study in writing, and who voluntarily volunteer to participate
Key exclusion criteria
Who are judged unsuitable for this study by principal investigator.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Suzuki |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
329-2762
Address
17, Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
080-1573-5837
Shigenori_Suzuki@kagome.co.jp
Public contact
Name of contact person
| 1st name | Minami |
| Middle name | |
| Last name | Ide |
Organization
Macromill, Inc.
Division name
Life Science Department
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo
TEL
070-2267-0435
Homepage URL
m_ide@macromill.com
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAGOME CO., LTD.
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
03-6240-1162
jimukyoku@tes-h.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2023-R20
Org. issuing International ID_1
KAGOME CO., LTD.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
帝都三崎町ビル（東京都）
アクトスリーホール（大阪府）
名駅IMAIビル（愛知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 02 | 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
520
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
| 2023 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 12 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
To investigate vegetable intake of elementary and junior high school students and their parents by measuring skin carotenoid level of them.
Management information
Registered date
| 2023 | Year | 10 | Month | 02 | Day |
Last modified on
| 2024 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059784
