UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000037306 |
|---|---|
| Receipt number | R000042507 |
| Scientific Title | Effect of amino acid intake on intermittent exercise performance. |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2019/07/08 17:56:41 |
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Basic information
Public title
Effect of amino acid intake on intermittent exercise performance.
Acronym
Effect of amino acid intake on intermittent exercise performance.
Scientific Title
Effect of amino acid intake on intermittent exercise performance.
Scientific Title:Acronym
Effect of amino acid intake on intermittent exercise performance.
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of amino acid intake on intermittent exercise performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
power output by bicycle ergometer
Key secondary outcomes
VO2, VCO2, Blood pH, Blood bicarbonate(HCO3-) level, Blood catecholamine level
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
(1)Amino acid intake
(2)Exercise loading by bicycle ergometer
(3)Blood sampling during or after exercise
(4)7 days wash out
(5)Placebo intake
(6)Exercise loading by bicycle ergometer
(7)Blood sampling during or after exercise
Interventions/Control_2
(1)Placebo intake
(2)Exercise loading by bicycle ergometer
(3)Blood sampling during or after exercise
(4)7 days wash out
(5)Amino acid intake
(6)Exercise loading by bicycle ergometer
(7)Blood sampling during or after exercise
Interventions/Control_3
(1)Amino acids mixture intake
(2)Exercise loading by bicycle ergometer
(3)Blood sampling during or after exercise
(4)7 days wash out
(5)Placebo intake
(6)Exercise loading by bicycle ergometer
(7)Blood sampling during or after exercise
Interventions/Control_4
(1)Placebo intake
(2)Exercise loading by bicycle ergometer
(3)Blood sampling during or after exercise
(4)7 days wash out
(5)Amino acids mixture intake
(6)Exercise loading by bicycle ergometer
(7)Blood sampling during or after exercise
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
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
(1)A healthy Japanese man aged from 20 to 29 years old at the time of informed consent.
(2) A person who have execise habits
(3) A person who provided informed consent by a document
Key exclusion criteria
(1)A person who has surgical injury and chronic disease.
(2) A person who has participated in other clinical study and monitor test or are planned to participate in other clinical study.
(3) A person who had 200 mL or more of blood taken within the past 12 weeks.
(4) A person who got sick by blood collection in the past.
(5) A person who is judged to be inappropriate for current study based on the medical chart by medical doctor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazushige |
| Middle name | |
| Last name | Goto |
Organization
Ritsumeikan University
Division name
College of Sport and Health Science
Zip code
525-8577
Address
1-1-1 Nojihigashi, Kusatsu shi, Shiga
TEL
077-599-4127
kagoto@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | koizumi |
Organization
Ajinomoto Co., Inc
Division name
Human health & nutrition group, Institute of food sciences & technologies
Zip code
210-8681
Address
1-1, Suzuki-tyo, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
044-223-4114
Homepage URL
Tomonori_koizumi@ajinomoto.com
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
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
Ritsumeikan University
Address
1-1-1 Nojihigashi, Kusatsu shi, Shiga
Tel
077-561-3412
b-rinri@st.ritsumei.ac.jp
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
| 2024 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 08 | Day |
Last modified on
| 2019 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042507
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
