UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of ingestion of Kale (Brassica oleracea) juice on physical size, intelligence, and common cold in primary school children -An open label study -
Title of the study (Brief title)	Effect of ingestion of Kale (Brassica oleracea) juice on physical size, intelligence, and common cold in primary school children
Region	Asia(except Japan)

Condition
Condition	Healthy subject
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate the effect of Kale (Brassica oleracea) juice on physical size, intelligence, and common cold in healthy elementary school children.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Physical size, Upper respiratory tract infection and diarrhea, Intelligence test (WISC-IV)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of kale juice for 8 consecutive months
Interventions/Control_2	Not intake of kale juice for 8 consecutive months
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Healthy boys and girls from elementary school 2 to 4 grade (2)The children and their parent (or guardian) can understand this study and have the written informed consent
Key exclusion criteria	(1) Subjects having physical and mental developmental disabilities, or a severe disease (2) Subjects taking antioxidant functional health foods or supplements (3)Subjects receiving anticoagulants or the intake restriction vitamin K (4) Subjects who cannot drink kale juice, (5) Subjects having allergy to brassica vegetable or dextrin (6) Subjects having a plan of moving during the test period (7)Subjects deemed unsuitable by the investigator
Target sample size	600

Research contact person
Name of lead principal investigator	Bui Thi Nhung
Organization	National Institute of Nutrition
Division name	School and Occupational Nutrition
Address	48B-Tang Bat Ho, Hanoi-Vietnam
TEL	+84-43971-7090
Email	nhungvnnin@gmail.com

Public contact
Name of contact person	Chie Tarumizu
Organization	FANCL Corporataion
Division name	Research Institute
Address	12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa 244-0806, Japan
TEL	+81-45-820-3443
Homepage URL
Email	chie_0904@fancl.co.jp

Sponsor
Institute	National Institute of Nutrition
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 11 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 05 Day
Anticipated trial start date	2016 Year 09 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 11 Month 08 Day
Last modified on	2018 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039649