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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033818
Receipt No. R000038549
Scientific Title A pilot study for effects of vegetable juice on children's preference and amount of consumption for vegetables
Date of disclosure of the study information 2018/12/01
Last modified on 2018/08/17

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Basic information
Public title A pilot study for effects of vegetable juice on children's preference and amount of consumption for vegetables
Acronym A pilot study for effects of vegetable juice on children's preference and amount of consumption for vegetables
Scientific Title A pilot study for effects of vegetable juice on children's preference and amount of consumption for vegetables
Scientific Title:Acronym A pilot study for effects of vegetable juice on children's preference and amount of consumption for vegetables
Region
Japan

Condition
Condition N/A
Classification by specialty
Not applicable Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the current study is to obtain exploratory pilot data about whether children's preference and amount of consumption for vegetables are increased by repetitive intake of vegetable-juice.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of vegetable consumption and preference of vegetables in children aged between 3 and 8 years are investigated before/after a 4-week period of repetitive intake of vegetable juice (Kagome, Yasai Seikatsu 100 original). At least 40 3-8-year old children will participate in the current study: 20 children for vegetable-juice group and the other 20 children for non-vegetable juice group (control group). Children in the control group do not intake any vegetable juice during the 4 week period. We examine whether the amount of vegetable consumption and preference for vegetable more increase in the vegetable-juice group than in the control group.
Amount of vegetable consumption is measured under laboratory-setting. Participants are invited to a laboratory and exposed to 5 kinds of vegetables (tomatoes, carrots, bell peppers, spinach, and eggplant). The participants are instructed to eat the vegetables as much as they want, and their amounts of consumption are measured. Preference for vegetables are measured by a questionnaire buttery for children and their parents. These measurements for the amount of vegetable consumption and the preference for vegetables are conducted twice; conducted once for each of before and after the repetitive consumption period of vegetable juice.
An additional measurement of the preference for vegetables is conducted one-month after the end of the repetitive consumption period of vegetable juice. This additional measurement is aimed to examine time decay of the effect of repetitive intake of vegetable juice on preference for vegetable.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food
Interventions/Control_1 intervention: with intake of vegetable juice
Interventions/Control_2 control: without intake of vegetable juice
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
3 years-old <=
Age-upper limit
8 years-old >=
Gender Male and Female
Key inclusion criteria Healthy children without any food allergy.
Key exclusion criteria Any one who dose not follow our instructions for the study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobu SHIRAI
Organization Niigata University
Division name Facluty of Humanities
Zip code
Address 2-8050 Ikararashi Nishi-ku Niigata-city
TEL 025-262-6451
Email shirai@human.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobu SHIRAI
Organization Niigata University
Division name Facluty of Humanities
Zip code
Address 2-8050 Ikararashi Nishi-ku Niigata-city
TEL 025-262-6451
Homepage URL
Email shirai@human.niigata-u.ac.jp

Sponsor
Institute Niigata University; Kagome CO,. Ltd.
Institute
Department

Funding Source
Organization Niigata University; Kagome CO,. Ltd.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 12 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 20 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
2018 Year 08 Month 20 Day
Last modified on
2018 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038549

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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