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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021525
Receipt No. R000024823
Scientific Title The effect of oral amino acids on physical function
Date of disclosure of the study information 2016/03/31
Last modified on 2017/09/15

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Basic information
Public title The effect of oral amino acids on physical function
Acronym The effect of oral amino acids on physical function
Scientific Title The effect of oral amino acids on physical function
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshio Suzuki
Organization Juntendo University
Division name Graduate School of Health and Sports Science
Zip code
Address 1-1 Hiragagakuendai, Inzai, Chiba
TEL 0476-98-1001
Email yssuzuki@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshio Suzuki
Organization Juntendo University
Division name Graduate School of Health and Sports Science
Zip code
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)

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 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

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
2016 Year 01 Month 16 Day
Date of IRB
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

Other
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

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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