UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061148 |
|---|---|
| Receipt number | R000069972 |
| Scientific Title | A Study on the Long-term Efficacy of an Amino Acid Mixture in Healthy Adults: A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial |
| Date of disclosure of the study information | 2026/04/05 |
| Last modified on | 2026/04/03 11:06:37 |
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Basic information
Public title
A Study on the Long-term Efficacy of an Amino Acid Mixture in Healthy Adults: A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial
Acronym
A Study on the Long-term Efficacy of an Amino Acid Mixture in Healthy Adults
Scientific Title
A Study on the Long-term Efficacy of an Amino Acid Mixture in Healthy Adults: A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial
Scientific Title:Acronym
A Study on the Long-term Efficacy of an Amino Acid Mixture in Healthy Adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study is aimed to evaluate the effects of 12-week intake of an amino acid mixture on physical and metabolic functions in healthy adults who report insufficient physical activity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
High-dose group: Skeletal Muscle Index (SMI)
Low-dose group: HbA1c
Key secondary outcomes
SMI (low-dose group only), HbA1c (high-dose group only), lower limb muscle mass, limb muscle mass, body fat percentage, balance, grip strength, fasting blood glucose, insulin, HOMA-IR, triglycerides (TG), free fatty acids (NEFA), POMS2 Short Form, SF-36
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will consume two sachets daily (test-food-2 and one control-food-1) for 12 weeks and perform specified resistance exercises and walking at designated frequency and duration during the same period.
Interventions/Control_2
Participants will consume two sachets daily (test-food-1 and one control-food-2) for 12 weeks and perform specified resistance exercises and walking at designated frequency and duration during the same period.
Interventions/Control_3
Participants will consume two sachets daily (control-food-1 and one control-food-2) for 12 weeks and perform specified resistance exercises and walking at designated frequency and duration during the same period.
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy adults aged 40 to under 60 at consent
2. Self-reported insufficient physical activity
3. Predominantly sedentary lifestyle (e.g., remote work)
4. Tendency to accumulate fat in the lower body
5. feeling physical fatigue frequently
6. Able to enter electronic diaries via PC or smartphone
7. Fully informed, capable of consent, and voluntarily agree in writing to participate
Key exclusion criteria
1. Aged 50 - 59 and meeting both AWGS2025 sarcopenia criteria:
a. Grip strength: <34 kg (men), <20 kg (women)
b. Limb muscle mass/height (BIA): <7.6 kg/m^2 (men), <5.7 kg/m^2 (women)
Also applies to those aged 40 - 49 meeting these values
2. Regular use of medications affecting muscle or lipid metabolism
3. Unable to discontinue supplements/health foods (including amino acid preparations, FOSHU, or functional foods)
4. Unable to abstain from alcohol from one day before screening and each test
5. History or current drug/alcohol dependence
6. Participation in other food, drug, or topical studies within one month prior to consent, or planning to join other studies during this trial
7. Systolic BP >=160 mmHg or diastolic BP >=100 mmHg at screening
8. Serious renal, gastrointestinal, cardiac, respiratory, endocrine, or metabolic diseases, or under treatment
9. Physical disabilities (e.g., back/knee pain) interfering with exercise
10. Orthopedic surgery affecting exercise (e.g., back, knee)
11. Implanted pacemaker or metal devices
12. Prohibited from exercise by a physician
13. History of vasovagal syncope
14. Currently receiving treatment for any disease (as-needed medication permitted)
15. Current or past food/drug allergies
16. Excessive alcohol consumption (>=40g pure alcohol/day)
17. Heavy smoking (>=21 cigarettes/day)
18. Shift workers with night shifts
19. Plans for major lifestyle changes (e.g., long trips) during the study
20. Deemed ineligible by the principal investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Nishitani |
Organization
Ajinomoto Co., Inc.
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki, 210-8681, Japan
TEL
080-1045-7701
shinobu.nishitani.vx8@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Kayama |
| Middle name | |
| Last name | Hirokuni |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
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
Suda Clinic institutional review board
Address
Takadanobaba,Shinjuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.co.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
| 2026 | Year | 04 | Month | 05 | 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
| 2025 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 28 | 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 | 04 | Month | 03 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069972
