UMIN-CTR Clinical Trial

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
Email	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
Email	kaito.takahashi@eu-phoria.jp

Sponsor
Institute	EUPHORIA Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052602