UMIN-CTR Clinical Trial

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
Last 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
Email	takanouchi_toshiya@jpm1960.org

Public contact
1st 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	Japan handball association
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034154