UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052803 |
|---|---|
| Receipt number | R000060082 |
| Scientific Title | Investigation of the effects of test food intake on professional volleyball players |
| Date of disclosure of the study information | 2023/11/17 |
| Last modified on | 2023/11/01 11:02:29 |
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Basic information
Public title
Investigation of the effects of test food intake on professional volleyball players
Acronym
Investigation of the effects of test food intake on professional volleyball players
Scientific Title
Investigation of the effects of test food intake on professional volleyball players
Scientific Title:Acronym
Investigation of the effects of test food intake on professional volleyball players
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate of the effects of test food intake on professional volleyball players
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of physical and subjective conditions through a web-based questionnaire
Injury incidence and game withdrawal rates compared to last year
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of test foods during the season (6 months)
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
People who are members of the professional women's volleyball team
Key exclusion criteria
People who do not agree with participation.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Takuto |
| Middle name | |
| Last name | Nakamura |
Organization
Toyama Medical Welfare College
Division name
Department of Physical Therapy
Zip code
936-0023
Address
149-9 Yanagihara, Namekawa City, Toyama Prefecture
TEL
076-476-0001
nakat@tif.ac.jp
Public contact
Name of contact person
| 1st name | Takuto |
| Middle name | |
| Last name | Nakamura |
Organization
Toyama Medical Welfare College
Division name
Department of Physical Therapy
Zip code
936-0023
Address
149-9 Yanagihara, Namekawa City, Toyama Prefecture
TEL
076-476-0001
Homepage URL
nakat@tif.ac.jp
Sponsor or person
Institute
Toyama Medical Welfare College
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
Toyama Medical Welfare College, Ethics Review Committee
Address
149-9 Yanagihara, Namekawa City, Toyama Prefecture
Tel
076-476-0001
sakai@tif.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
| 2023 | Year | 11 | Month | 17 | 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
| 2023 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 15 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060082
| 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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