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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029374
Receipt No. R000033569
Scientific Title Protein metabolism in elite swimmer during training period
Date of disclosure of the study information 2017/10/02
Last modified on 2019/05/13

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Basic information
Public title Protein metabolism in elite swimmer during training period
Acronym Protein metabolism in elite swimmer
Scientific Title Protein metabolism in elite swimmer during training period
Scientific Title:Acronym Protein metabolism in elite swimmer
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Determine recommendation for nutrition (especially protein) in elite swimmer through evaluating nutritional practice and protein metabolism over training period
Basic objectives2 Others
Basic objectives -Others Determine recommendation for protein intake in elite 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 Male and Female
Key inclusion criteria Participant who is not retired, joined international competition (such as Olympic games, world championships or so on.) as Japanese representatives, or meets the "International standard" criteria set by Japan Swimming Federation.
Participants will be 20-35 years old or 18-20 years old with his 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 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Futoshi Ogita
Organization National Institute of Fitness and Sports in Kanoya
Division name College of Physical Education, Sports Performance
Zip code
Address 1 Shiromizucho, Kanoya, Kagoshima Prefecture 891-2311
TEL 0994-46-4931
Email ogita@nifs-k.ac.jp

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
Email hiroyuki_kato@ajinomoto.com

Sponsor
Institute National Institute of Fitness and Sports in Kanoya
Institute
Department

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
Email

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 10 Month 02 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 09 Month 30 Day
Date of IRB
2017 Year 08 Month 24 Day
Anticipated trial start date
2017 Year 10 Month 05 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 Completed

Management information
Registered date
2017 Year 10 Month 02 Day
Last modified on
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033569

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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