UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061066 |
|---|---|
| Receipt number | R000069766 |
| Scientific Title | Effect of Essential Amino Acid Supplementation on Muscle Mass Gain following Resistance Training |
| Date of disclosure of the study information | 2026/04/13 |
| Last modified on | 2026/04/13 11:48:23 |
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Basic information
Public title
Essential Amino Acid Study
Acronym
EAA Study
Scientific Title
Effect of Essential Amino Acid Supplementation on Muscle Mass Gain following Resistance Training
Scientific Title:Acronym
EAA-MMD Study
Region
| Japan |
Condition
Condition
Not applicable: Healthy women volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of long-term essential amino acid intake on muscle mass gain.
Basic objectives2
Others
Basic objectives -Others
Comparison of muscle mass gains between the essential amino acid group, the protein group and the placebo group.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in human muscle mass following a training intervention (pre-intervention and 12 weeks post-intervention).
Key secondary outcomes
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
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Use the essential amino acid mixture (manufactured by Toyo Shinyaku).The study will be conducted as a crossover trial, with participants taking 8 g of powder containing 3.0 g of essential amino acids after training on training days and after breakfast on other days (once daily for a total of 12 weeks).
Interventions/Control_2
Whey protein (manufactured by Sankyo Food Industries) will be used. Participants will consume 14.6 g of whey protein (containing 9.0 g of protein) after training on days when they train, and after breakfast on other days (once daily for a total of 12 weeks), in a crossover design.
Interventions/Control_3
A carbohydrate supplement based primarily on dextrin is used. A total of 13.75 g of starch hydrolysate, containing 13 g of dextrin, is taken after training on training days and after breakfast on other days (once daily for a total of 12 weeks) in a crossover study.
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy women aged between 50 and 75.
Participants who have been assessed by the principal investigator or a co-investigator and found to be in good health.
Participants who have received a full explanation of the studys objectives and methods and have provided written consent.
Key exclusion criteria
Those who regularly undertake resistance training.
Those who regularly consume amino acids or protein supplements.
Those with an allergy to milk or soya contained in the test food.
Those with orthopaedic conditions affecting the upper or lower limbs.
Those with a low body fat percentage (less than 20%).
Any other individuals deemed unsuitable by the medical director (doctor).
Target sample size
60
Research contact person
Name of lead principal investigator
| 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, Nojihigashi, Kusatsu, Shiga
TEL
077-561-5229
safujita@fc.ritsumei.ac.jp
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, Nojihigashi, Kusatsu, Shiga
TEL
077-561-5229
Homepage URL
safujita@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
Curves Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ritsumeikan University
Address
1-1-1 Nojihigashi, Kusatsu, Shiga
Tel
077-599-4175
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
立命館大学（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 03 | Month | 26 | Day |
Last modified on
| 2026 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069766
