UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055296 |
|---|---|
| Receipt number | R000063184 |
| Scientific Title | Effect of amino acids-containing food on skeletal muscle |
| Date of disclosure of the study information | 2026/03/02 |
| Last modified on | 2026/03/02 05:52:22 |
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Basic information
Public title
Effect of amino acids-containing food on skeletal muscle
Acronym
Effect of amino acids-containing food on skeletal muscle
Scientific Title
Effect of amino acids-containing food on skeletal muscle
Scientific Title:Acronym
Effect of amino acids-containing food on skeletal muscle
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of amino acids- containing food on skeletal muscle mass
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lean mass in arms
Key secondary outcomes
Total lean body mass
Total body fat mass
Base
Study type
Interventional
Study design
Basic design
Parallel
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Amino acids
Interventions/Control_2
Placebo
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy Male
Individuals aged 18 or higher and less than 40 years old
Individuals who do not have a habit of resistance training
Individuals who can make self-judgment and voluntarily provides written informed consent
Key exclusion criteria
Individual who cannot participate in resistance training due to injury
Individuals who have medical disease at the time of obtaining consent
Individual who cannot participate in resistance training three times a week at Ritsumeikan University
Individual who regularly take supplements (including protein)
Individual who are allergic to milk and soybeans
Individuals who are going to participate other studies during this study
Individuals who are receiving drug treatment at the time of obtaining consent
Individuals who have history of present illness related to hepatic, kidney, heart, lung, and cardiovascular disorder
Individuals who are assessed to be inappropriate by the principal medical doctor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kato |
Organization
Ajinomoto Co., Inc.
Division name
Sports & Health Nutrition Department
Zip code
104-8315
Address
15-1, Kyobashi 1-chome, Chuo-ku, Tokyo, Japan
TEL
080-8825-9706
hiroyuki.kato.c8n@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Fujita |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1 Noji-higashi, Kusatsu Shiga 525-8577 JAPAN
TEL
077-561-5229
Homepage URL
safujita@fc.ritsumei.ac.jp
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
Ethical Committee of Ajinomoto Co., Inc.,
Address
15-1, Kyobashi 1-chome, Chuo-ku, Tokyo, Japan
Tel
03-5250-8111
ajinomoto_irb@ajinomoto.com
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
| 2026 | Year | 03 | Month | 02 | 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
| 2024 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 21 | Day |
Last modified on
| 2026 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063184
