UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057684 |
|---|---|
| Receipt number | R000065914 |
| Scientific Title | A survey of the dietary habits and physical condition (vague complaints) of university athletes and the effects of nutritional guidance |
| Date of disclosure of the study information | 2025/04/30 |
| Last modified on | 2026/01/22 09:41:42 |
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Basic information
Public title
A survey of the dietary habits and physical condition (vague complaints) of university athletes and the effects of nutritional guidance
Acronym
A survey of the dietary habits and physical condition (vague complaints) of university athletes and the effects of nutritional guidance
Scientific Title
A survey of the dietary habits and physical condition (vague complaints) of university athletes and the effects of nutritional guidance
Scientific Title:Acronym
A survey of the dietary habits and physical condition (vague complaints) of university athletes and the effects of nutritional guidance
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The research director has previously provided nutritional support to athletes (including junior athletes in middle and high schools). In the process, he has observed many cases where athletes' condition has deteriorated due to an inappropriate diet, leading to poor performance and injury. He believes that an urgent task is to make the general public aware that improving daily eating habits can improve the quality of practice and prevent injury and illness.
He will therefore use a questionnaire to investigate the dietary status of athletes, and provide nutritional guidance to athletes based on the problems identified from the questionnaire results. He will then conduct another questionnaire survey to confirm whether the guidance has resulted in any changes in the athletes' eating behavior.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. First questionnaire survey (January-February 2025)
(1) Eating habits (2) Opportunities for nutritional guidance (3) Contents of supplementary meals (4) Themes of nutritional guidance (5) Concerns regarding meals (6) Presence of vague symptoms, etc.
2. Second questionnaire survey (April-May 2025)
(1) Presence of vague symptoms
Nutrition guidance (July 2025-January 2026)
3. Third questionnaire survey (July 2025-January 2026)
A questionnaire survey will be conducted after the nutritional guidance is implemented to review the content.
4. Fourth questionnaire survey (February 2026)
(1) Eating habits (2) Opportunities for nutritional guidance (3) Contents of supplementary meals (4) Themes of nutritional guidance (5) Concerns regarding meals (6) Items such as presence of vague symptoms
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
Nutritional guidance
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
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Athletes belonging to the sports club
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Bando |
Organization
Shikoku University
Division name
Faculty of Human Life Sciences,Department of Health and Nutrition
Zip code
771-1192
Address
123-1, Ebisu-no, Furukawa, Ojin-cho, Tokushima City, Tokushima Prefecture
TEL
088-665-9332
bando-kenichi@shikoku-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Bando |
Organization
Shikoku University
Division name
Faculty of Human Life Sciences,Department of Health and Nutrition
Zip code
771-1192
Address
123-1, Ebisu-no, Furukawa, Ojin-cho, Tokushima City, Tokushima Prefecture
TEL
088-665-9332
Homepage URL
bando-kenichi@shikoku-u.ac.jp
Sponsor or person
Institute
Shikoku University
Institute
Department
Personal name
Funding Source
Organization
Shikoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shikoku University
Address
123-1, Ebisu-no, Furukawa, Ojin-cho, Tokushima City, Tokushima Prefecture
Tel
088-665-9332
bando-kenichi@shikoku-u.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
| 2025 | Year | 04 | Month | 30 | 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
| 2025 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | 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
| 2025 | Year | 04 | Month | 22 | Day |
Last modified on
| 2026 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065914
