UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of oral amino acids on physical function
Title of the study (Brief title)	The effect of oral amino acids on physical function
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to investigate the effect of amino acids on physical function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Ergometer (1week after administration)
Key secondary outcomes	Psychological tests by using the visual analog scale (VAS) blood examination

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of placebo for 7 days -> washout period for more than 3 weeks -> intake of amino acids for 7 days
Interventions/Control_2	Intake of amino acids for 7 days -> washout period for more than 3 weeks -> intake of placebo for 7 days
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	25 years-old >=
Gender	Male
Key inclusion criteria	Male collegiate soccer players PWC75%HRmax is more than 160W Subjects who have a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent Subjects who can pedal ergometer at more than 60 rpm for 12min on work rate of 60rpm and PWC75%HRmax.
Key exclusion criteria	1) Subject having medical treatment in a hospital or clinic 2) Subject having treatment or previous history for serious cardiovascular, respiratory, endocrine, or metabolic disorders 3) smoker 4) Subject who ended participation in another clinical trial less than 3 months before 5) Subject having cedar or cypress pollen allergy 6) Subject who has had a blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months of the start of the present study 7) Subjects who have an intake of amino acids supplement 8) Subject deemed unsuitable by the investigator 9) Subject having previous history for chest pain or faint 10) Subjects who have participated in other clinical study within the last 3 months prior to the current study or are participating in other clinical study currently
Target sample size	24

Research contact person
Name of lead principal investigator	Yoshio Suzuki
Organization	Juntendo University
Division name	Graduate School of Health and Sports Science
Address	1-1 Hiragagakuendai, Inzai, Chiba
TEL	0476-98-1001
Email	yssuzuki@juntendo.ac.jp

Public contact
Name of contact person	Yoshio Suzuki
Organization	Juntendo University
Division name	Graduate School of Health and Sports Science
Address	1-1 Hiragagakuendai, Inzai, Chiba
TEL	0476-98-1001
Homepage URL
Email	yssuzuki@juntendo.ac.jp

Sponsor
Institute	Juntendo University, Graduate School of Health & Sports Science
Institute
Department

Funding Source
Organization	KYOWA HAKKO BIO CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
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	順天堂大学大学院スポーツ健康科学研究科（千葉県）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 16 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 02 Month 08 Day

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

Management information
Registered date	2016 Year 03 Month 18 Day
Last modified on	2017 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024823