UMIN-CTR Clinical Trial

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 Nobu Middle name Last name SHIRAI
Organization	Niigata University
Division name	Facluty of Humanities
Zip code	950-2181
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 Nobu Middle name Last name SHIRAI
Organization	Niigata University
Division name	Facluty of Humanities
Zip code	950-2181
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	Niigata University
Address	2-8050 Ikararashi Nishi-ku Niigata-city
Tel	025-262-6451
Email	shirai@human.niigata-u.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	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	40
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	2018 Year 08 Month 16 Day
Date of IRB	2018 Year 10 Month 31 Day
Anticipated trial start date	2018 Year 08 Month 20 Day
Last follow-up date	2019 Year 12 Month 31 Day
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	2020 Year 03 Month 02 Day

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