UMIN-CTR Clinical Trial

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
Email	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
Email	yo-kitamura@morinagamilk.co.jp

Sponsor
Institute	Sagami Women's University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048389