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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034817
Receipt No. R000039649
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 -
Date of disclosure of the study information 2018/11/08
Last modified on 2018/11/08

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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