UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053590 |
|---|---|
| Receipt number | R000061147 |
| Scientific Title | Antioxidant capacity and psychological effects of vegetable and vegetable juice consumption in junior high school students participating in a basketball team. |
| Date of disclosure of the study information | 2024/02/10 |
| Last modified on | 2024/02/09 16:12:05 |
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Basic information
Public title
Vegetable Intake Increase Project
Acronym
Vegetable Intake Increase Project
Scientific Title
Antioxidant capacity and psychological effects of vegetable and vegetable juice consumption in junior high school students participating in a basketball team.
Scientific Title:Acronym
Antioxidant capacity and psychological effects of vegetable and vegetable juice consumption
Region
| Japan |
Condition
Condition
basketball players
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A dietary survey conducted in July 2023 observed deficiencies in dietary fiber, retinol, vitamin C, etc. were observed. Therefore, this study aims to supplement these deficient nutrients with vegetables and vegetable juices and examine their antioxidant capacity and psychological effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary oxidative stress marker: Urinary 8OH-dG
Mood profile test: POMS2
Diet history questionnaire: BDHQ
Questionnaire on attitudes toward vegetable intake and use of supplements
Key secondary outcomes
Estimated vegetable intake measurement: Veg-Check
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
The participants are asked to drink one 200mL bottle of vegetable juice every day for 6 weeks and to actively consume vegetables at home.
Interventions/Control_2
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
| 11 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male
Key inclusion criteria
Players on basketball teams
Key exclusion criteria
None
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Ohta |
Organization
Fukuoka Women's University
Division name
International College of Arts and Sciences, Department of Food and Health Sciences
Zip code
813-8529
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka, Japan
TEL
092-661-2411
m-ohta@fwu.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Ohta |
Organization
Fukuoka Women's University
Division name
International College of Arts and Sciences, Department of Food and Health Sciences
Zip code
813-8529
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka, Japan
TEL
092-661-2411
Homepage URL
m-ohta@fwu.ac.jp
Sponsor or person
Institute
Fukuoka Wimen's University
Institute
Department
Personal name
Funding Source
Organization
Yazuya Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee of Fukuoka Women's University
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka, Japan
Tel
092-661-2411
soumu2@fwu.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 | 02 | Month | 10 | 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 | 26 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 24 | 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 | 02 | Month | 10 | Day |
Last modified on
| 2024 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061147
| Research Plan | |
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| 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 |
