UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025850 |
|---|---|
| Receipt number | R000029705 |
| Scientific Title | Effect of amino acid mixture on exercise performance |
| Date of disclosure of the study information | 2017/01/27 |
| Last modified on | 2018/01/26 19:26:11 |
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Basic information
Public title
Effect of amino acid mixture on exercise performance
Acronym
Effect of amino acid mixture on exercise performance
Scientific Title
Effect of amino acid mixture on exercise performance
Scientific Title:Acronym
Effect of amino acid mixture on exercise performance
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of amino acid mixture on exercise performance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Wingate anaerobic performance
Key secondary outcomes
Grip strength
Isokinetic leg extension strength
Muscle temperature
Body temperature
Rate of perceived exertion (RPE)
Blood lactic acid level
Blood glucose level
Blood free fatty acid level
Blood total ketone body level
Blood adrenaline level
Blood noradrenaline level
Blood dopamine 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
YES
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food (capsules containing 3,000 mg of amino acid mixture) twice per day for 3 days and exercise on the third day
Washout (no less than 6 days)
Ingestion of placebo food (capsules not containing amino acid mixture) twice per day for 3 days and exercise on the third day
Interventions/Control_2
Ingestion of placebo food (capsules not containing amino acid mixture) twice per day for 3 days and exercise on the third day
Washout (no less than 6 days)
Ingestion of test food (capsules containing 3,000 mg of amino acid mixture) twice per day for 3 days and exercise on the third 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
| Not applicable |
Gender
Male
Key inclusion criteria
1. Persons who give written consent
2. Healthy adults aged 20 years or older
3. Persons capable of endurance exercise
Key exclusion criteria
1. Persons who have any food alergy
2. Persons who have blood drawn (200 mL in the month or 400 mL in the 3 months before the interventions)
3. Persons judged inadequate by the investigator
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suguru Fujiwara |
Organization
CPCC Company Limited
Division name
Clinical Research Planning Department
Zip code
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5927-3112
s.fujiwara@cpcc.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Ichinohe |
Organization
CPCC Company Limited
Division name
Plan Sales Department
Zip code
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5927-3112
Homepage URL
m.i@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Food Science Research Laboratories, Meiji 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
チヨダパラメディカルケアクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 27 | 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
| 2017 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 24 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 25 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 26 | Day |
Last modified on
| 2018 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029705
| Research Plan | |
|---|---|
| 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 |
