UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023934 |
|---|---|
| Receipt number | R000027563 |
| Scientific Title | 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 | 2016/09/06 |
| Last modified on | 2017/07/06 20:07:30 |
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Basic information
Public title
Effect of ingestion of Kale (Brassica oleracea) juice on physical size, intelligence, and common cold in primary school children -An open label study -
Acronym
Effect of ingestion of Kale juice on physical size, intelligence, and common cold in primary school children
Scientific Title
Effect of ingestion of Kale (Brassica oleracea) juice on physical size, intelligence, and common cold in primary school children -An open label study -
Scientific Title:Acronym
Effect of ingestion of Kale juice on physical size, intelligence, and common cold in primary school children
Region
| Asia(except Japan) |
Condition
Condition
Healthy volunteer
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
WISC-IV score (WMI, PSI), physical size(Height, weight, eyesight, grip strength), frequency of ULTI and diarrhea
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of kale juice 5days a week in 9-month treatment period
Interventions/Control_2
Not ingesution of kale juice in 9-month treatment period
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
| 7 | years-old | <= |
Age-upper limit
| 11 | years-old | >= |
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 investigato
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Yui |
Organization
FANCL Corporation
Division name
Fancl Research Institute
Zip code
Address
12-13 Kamishinano, Totsuka-ku, Yokohama
TEL
045-820-3532
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayuri Matsuoka |
Organization
FANCL Corporation
Division name
Fancl Research Institute
Zip code
Address
12-13 Kamishinano, Totsuka-ku, Yokohama
TEL
045-820-3449
Homepage URL
matsuoka@fancl.co.jp
Sponsor or person
Institute
National Institute of Nutrition, Vietnam
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 09 | Month | 06 | 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
| 2016 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 05 | Day |
Last modified on
| 2017 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027563
