UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029896 |
|---|---|
| Receipt number | R000034154 |
| Scientific Title | Protein metabolism in female handball players over training period |
| Date of disclosure of the study information | 2017/11/12 |
| Last modified on | 2019/05/13 11:42:11 |
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Basic information
Public title
Protein metabolism in female handball players over training period
Acronym
Protein metabolism in handball players
Scientific Title
Protein metabolism in female handball players over training period
Scientific Title:Acronym
Protein metabolism in handball players
Region
| Japan |
Condition
Condition
Health adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determine recommendation for nutrition (especially protein) in handball players through evaluating nutritional practice and protein metabolism over training period
Basic objectives2
Others
Basic objectives -Others
Determine recommendation for protein intake in trained subjects
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nitrogen balance
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
| 35 | years-old | >= |
Gender
Female
Key inclusion criteria
female adults who belong to japanese national handball team and participates in the training camp.
Participants will be 20-35 years old or18-20 years old with her guardian's consent.
Participants are willing to abide by the compliance rules of this study.
Key exclusion criteria
Those who has surgical or medical disease.
Inability to adhere to any of the compliance rules judged by principle investigator or medical doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiya Takanouchi |
Organization
Japan handball association
Division name
Medical committee
Zip code
Address
23 Honshio-cho, Shinjuku-ku, Tokyo
TEL
03-6709-8940
takanouchi_toshiya@jpm1960.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kato |
Organization
AJINOMOTO CO. INC.
Division name
Nutrition and Health Science Group
Zip code
Address
1-1 Suzuki-Cho, Kawasaki-Ku, Kawasaki-Shi, Kanagawa
TEL
044-244-7180
Homepage URL
hiroyuki_kato@ajinomoto.com
Sponsor or person
Institute
Japan handball association
Institute
Department
Personal name
Funding Source
Organization
AJINOMOTO CO. INC.
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
Address
Tel
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
| 2017 | Year | 11 | Month | 12 | 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
| 2017 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study was concluded
Management information
Registered date
| 2017 | Year | 11 | Month | 09 | Day |
Last modified on
| 2019 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034154
