UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054034 |
|---|---|
| Receipt number | R000061517 |
| Scientific Title | A study on the habitualization of vegetable intake among university students |
| Date of disclosure of the study information | 2024/04/02 |
| Last modified on | 2024/04/17 14:26:07 |
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Basic information
Public title
A study on the habitualization of vegetable intake among university students
Acronym
A study on the habitualization of vegetable intake among university students
Scientific Title
A study on the habitualization of vegetable intake among university students
Scientific Title:Acronym
A study on the habitualization of vegetable intake among university students
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether distributing condiments to university students can increase their vegetable intake and help them develop appropriate vegetable eating habits.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vegetable Intake (Pre-test, 6,12 Weeks After the Intervention, and 12 Weeks After Test Completion)
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Distribution of Condiments and Their Free Use (Target: 15 mL/Day, 12 Weeks)
Interventions/Control_2
To continue their normal daily lives
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy university students
Key exclusion criteria
1,Individuals with food allergies (eggs,soybeans,apples)
2.Individuals with chronic digestive diseases requiring continuous medication or treatment (excluding seasonal medication for conditions such as rhinitis or headache)
3.Individuals living in boarding houses with meals provided, who cannot choose their own meals
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Tomoyori |
Organization
Prefectural University of Kumamoto
Division name
Faculty of Environmental & Symbiotic Sciences
Zip code
862-8502
Address
3-1-100 Tsukide, Higashi-ku, Kumamoto City, Kumamoto Prefecture
TEL
096-383-2929
tomoyori@pu-kumamoto.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nishiyama |
Organization
Kewpie Corporation
Division name
Research and Development Division
Zip code
182-0002
Address
2-5-7 Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
Homepage URL
hiroshi_nishiyama@kewpie.co.jp
Sponsor or person
Institute
Prefectural University of Kumamoto
Institute
Department
Personal name
Funding Source
Organization
Kewpie 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
Prefectural University of Kumamoto ,Institutional Review Board
Address
3-1-100 Tsukide, Higashi-ku, Kumamoto City, Kumamoto Prefecture
Tel
096-321-6612
puk-kenkyu@pu-kumamoto.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
| 2024 | Year | 04 | Month | 02 | 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
| 2024 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2024 | Year | 04 | Month | 02 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061517
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
