UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046117 |
|---|---|
| Receipt number | R000052602 |
| Scientific Title | Self-assessment of the dietary intake and fatigue, and sleep quality among collegiate level athletes in Japan. |
| Date of disclosure of the study information | 2021/11/19 |
| Last modified on | 2022/03/25 16:06:55 |
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Basic information
Public title
Self-assessment of the dietary intake and fatigue, and sleep quality among collegiate level athletes in Japan.
Acronym
Self-assessment of the dietary intake and fatigue, and sleep quality among collegiate level athletes in Japan.
Scientific Title
Self-assessment of the dietary intake and fatigue, and sleep quality among collegiate level athletes in Japan.
Scientific Title:Acronym
Self-assessment of the dietary intake and fatigue, and sleep quality among collegiate level athletes in Japan.
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine whether the different competition levels and the different characteristics of sports can impact the daily diet, the sleep quality and the fatigue level of the athletes from the various collegiate teams.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to examine whether the different competition levels and the different characteristics of sports can impact the daily diet, the sleep quality and the fatigue level of the athletes from the various collegiate teams.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Self-assessment score of the dietary intake
- The PSQI score
- Self-assessment score of fatigue
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Collegiate level athletes.
Key exclusion criteria
Injured and patient.
Target sample size
1275
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kuroyanagi |
Organization
EUPHORIA Co., Ltd.
Division name
Business Development Department
Zip code
102-0085
Address
Iidabiru2F 5-5 Rokubancho, Chiyoda-ku, Tokyo-to
TEL
03-6388-9260
hiroki.kuroyanagi@eu-phoria.jp
Public contact
Name of contact person
| 1st name | Kaito |
| Middle name | |
| Last name | Takahashi |
Organization
EUPHORIA Co., Ltd.
Division name
Business Development Department
Zip code
102-0085
Address
Iidabiru2F 5-5 Rokubancho, Chiyoda-ku, Tokyo-to
TEL
03-6388-9260
Homepage URL
kaito.takahashi@eu-phoria.jp
Sponsor or person
Institute
EUPHORIA Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
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
EUPHORIA Co., Ltd.
Address
Iidabiru2F 5-5 Rokubancho, Chiyoda-ku, Tokyo-to
Tel
03-6388-9260
ryosuke.takahashi@eu-phoria.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
| 2021 | Year | 11 | Month | 19 | 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
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questionnaire.
Management information
Registered date
| 2021 | Year | 11 | Month | 19 | Day |
Last modified on
| 2022 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052602
