UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042391 |
|---|---|
| Receipt number | R000048389 |
| Scientific Title | A cross-sectional study on dietary intakes and health in high-school students |
| Date of disclosure of the study information | 2020/11/11 |
| Last modified on | 2021/05/11 09:22:33 |
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Basic information
Public title
A cross-sectional study on dietary intakes and health in high-school students
Acronym
Dietary intakes and health in high-school students
Scientific Title
A cross-sectional study on dietary intakes and health in high-school students
Scientific Title:Acronym
Dietary intakes and health in high-school students
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the dietary intakes and health in high-school students
Basic objectives2
Others
Basic objectives -Others
A cross-sectional study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dietary intakes
Questionnaire of health and lifestyle habits
Estimated hemoglobin levels
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
| 15 | years-old | <= |
Age-upper limit
| 19 | years-old | > |
Gender
Female
Key inclusion criteria
1) More than 15 years and less than 19 years old.
2) Subjects who have no problems in daily life.
Key exclusion criteria
1) Subjects who are judged inappropriate for the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Chiharu |
| Middle name | |
| Last name | Tsutsumi |
Organization
Sagami Women's University
Division name
Faculty of Nutritional Science Department of Nutrition and Health
Zip code
252-0383
Address
2-1-1 Bunkyo, Minami-ku, Sagamihara -City, Kanagawa-pref.
TEL
042-742-2013
tsutsumi_chiharu@isc.sagami-wu.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Kitamura |
Organization
Morinaga Milk Industry Co., LTD.
Division name
Wellness & Nutrition Science Institute, R&D Division
Zip code
252-8583
Address
1-83,5-Chome, Higashihara, Zama-City, Kanagawa-pref.
TEL
046-252-3046
Homepage URL
yo-kitamura@morinagamilk.co.jp
Sponsor or person
Institute
Sagami Women's University
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Nippon Dental University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Sagami Women's University
Address
2-1-1 Bunkyo, Minami-ku, Sagamihara -City, Kanagawa-pref.
Tel
042-742-1442
tsutsumi_chiharu@isc.sagami-wu.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 11 | 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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
We investigate the dietary intakes and health in high-school students.
Management information
Registered date
| 2020 | Year | 11 | Month | 09 | Day |
Last modified on
| 2021 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048389
