UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054332 |
|---|---|
| Receipt number | R000062050 |
| Scientific Title | Implementation of nutritional support for dual athlete, baseball players and evaluation of its effectiveness: a single arm pre- and post-comparison design |
| Date of disclosure of the study information | 2024/05/08 |
| Last modified on | 2025/11/07 12:06:02 |
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Basic information
Public title
Implementation of a nutritional support for baseball players and evaluation of its effectiveness
Acronym
Implementation of a nutritional support for baseball players and evaluation of its effectiveness
Scientific Title
Implementation of nutritional support for dual athlete, baseball players and evaluation of its effectiveness: a single arm pre- and post-comparison design
Scientific Title:Acronym
Implementation of nutritional support for dual athlete, baseball players and evaluation of its effectiveness
Region
| Japan |
Condition
Condition
Athlete
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify dietary challenges among dual-athlete baseball players, and to design and implement nutritional support necessary to resolve these challenges.
And to evaluate the effectiveness of nutritional support using primary outcomes (physical measurements, laboratory tests, food intake and nutritional status) and secondary outcomes (dietary awareness, eating behavior, and subjective health indicators such as fatigue and vitality).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body measurements (weight, body composition, limb circumference)
Laboratory test values (blood and biochemistry test items)
Energy, nutrients and food Intake
Key secondary outcomes
Consciousness of healthy eating
Eating behavior,
Subjective health indicators (fatigue, vitality, etc.)
Presenteeism
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
| Behavior,custom |
Interventions/Control_1
Nutritional support for 6 months
1) Mini-lectures for all players
2) Individual support for self-management of food intake
3) Individual feedback on results of dietary survey and body composition measurement
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Japanese
2. Ages >= 18 years
3. Dual athletes who are both players for the team and employees of the owner companies of the team
4. Having provided voluntary written consent for participation in this study
5. Able to follow the instructions of the research team member
Key exclusion criteria
. Athletes under treatment for diabetes, kidney disease, cardiovascular disease, or liver disease 2. Pregnant women
2. Athletes who have not participated in practices or games due to injury or illness
3. Athletes Judged by the project leader to be ineligible for other reason
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Narumi |
| Middle name | |
| Last name | Nagai |
Organization
University of Hyogo
Division name
School of Human Science and Environment
Zip code
670-0092
Address
1-1-12 Shinzaike-honcho, Himeji, Hyogo, 670-0092 Japan
TEL
+81-79-292-1515
nagai.lab.uh@gmail.com
Public contact
Name of contact person
| 1st name | Narumi |
| Middle name | |
| Last name | Nagai |
Organization
University of Hyogo
Division name
School of Human Science and Environment
Zip code
670-0092
Address
1-1-12 Shinzaike-honcho, Himeji, Hyogo, 670-0092 Japan
TEL
+81-79-292-1515
Homepage URL
nagai.lab.uh@gmail.com
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The SHSE (School of Human Science and Environment) Research Ethics Committee of the University of Hyogo
Address
1-1-12 Shinzaike-honcho, Himeji, Hyogo
Tel
+81-79-292-1515
u_hyogo_kankyou@ofc.u-hyogo.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 | 05 | Month | 08 | 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
21
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062050
