UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Protein requirement in Japanese athletes assessed by indicator amino acid oxidation technique
Title of the study (Brief title)	Protein requirement in Japanese athletes
Region	Japan

Condition
Condition	Athletes
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine dietary protein requirement of Japanese collegiate athletes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Concentration of carbon dioxide in expired gas
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Strength athletes ingest protein in the range of 1.0~3.0g/kg BW/day
Interventions/Control_2	Endurance athletes ingest protein in the range of 1.0~2.5g/kg BW /day
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	25 years-old >
Gender	Male
Key inclusion criteria	Healthy male collegiate athletes Subjects who informed consent was obtained
Key exclusion criteria	Subjects with egg-allergies
Target sample size	30

Research contact person
Name of lead principal investigator	Motoko Taguchi
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima, Tokorozawa, Saitama , 359-1192
TEL	+81-4-2947-6778
Email	mtaguchi@waseda.jp

Public contact
Name of contact person	Satoko Nagasaka
Organization	Waseda University
Division name	Graduate School of Sport Sciences
Address	2-579-15 Mikajima, Tokorozawa, Saitama , 359-1192
TEL	+81-4-2947-6778
Homepage URL
Email	s.nagasaka@akane.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Waseda University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 11 Month 30 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 11 Month 24 Day
Anticipated trial start date	2015 Year 11 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 11 Month 24 Day
Last modified on	2017 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022991