UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033818 |
|---|---|
| Receipt number | 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 | 2020/03/02 10:08:58 |
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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 | 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
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
shirai@human.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University; Kagome CO,. Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038549
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| Registered date | File name |
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