UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021525 |
|---|---|
| Receipt number | 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 10:44:47 |
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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
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
yssuzuki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Graduate School of Health & Sports Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024823
