UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047772 |
|---|---|
| Receipt number | R000054459 |
| Scientific Title | A study on set meals and vegetable intake in cafeteria for college athletes |
| Date of disclosure of the study information | 2022/05/16 |
| Last modified on | 2023/06/21 11:29:42 |
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Basic information
Public title
Survey of athletes' preferred cafeteria set meals and vegetable intake
Acronym
Athletes Vegetable Intake
Scientific Title
A study on set meals and vegetable intake in cafeteria for college athletes
Scientific Title:Acronym
Set meals and vegetable intake at a cafeteria for athletes
Region
| Japan |
Condition
Condition
Healthy person (Athlete)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We are to clarify whether a set meal in the cafeteria affects the vegetable intake of athletes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vegetable intake
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Method of serving set meals
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) College athlete
2) Those from whom the voluntary consent were obtained and who voluntarily consent being a subject and a surrogate
Key exclusion criteria
1) Those who are taking medicine
2) Those who are undergoing treatment for heart, liver, kidney, lungs, blood, digestive system, endocrine and metabolic disease or those who have a history of these
3) Those who are allergic to the ingredients contained in the test meal
4) Those who drink or smoke excessively
5) Those who have not regular lifestyle
6) Those who could not obtained consent in advance
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Machida |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1 Hirakagakuendai, Inzai, Chiba 270-1695 JAPAN
TEL
0476-98-1001
machidas@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shuichi |
| Middle name | |
| Last name | Machida |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1 Hirakagakuendai, Inzai, Chiba 270-1695 JAPAN
TEL
0476-98-1001
Homepage URL
machidas@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Health and Sports Science
Institute
Department
Personal name
Funding Source
Organization
Kagome Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
KAGOME CO., LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee in Juntendo University Graduate School of Health and Sports Science
Address
1-1 Hirakagakuendai, Inzai, Chiba 270-1695 JAPAN
Tel
0476-98-1001
sc-kyomu@juntendo.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
順天堂大学さくらキャンパス（千葉県）
流通経済大学龍ケ崎キャンパス（茨城県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 16 | 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
| 2022 | Year | 05 | Month | 16 | Day |
Last modified on
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054459
| 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 |
