UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057951 |
|---|---|
| Receipt number | R000066251 |
| Scientific Title | A verification study of blood amino acid levels at intake of protein material: a crossover comparison study |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2025/12/29 14:28:01 |
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Basic information
Public title
A verification study of blood amino acid levels at intake of protein material
Acronym
A verification study of blood amino acid levels at intake of protein material
Scientific Title
A verification study of blood amino acid levels at intake of protein material: a crossover comparison study
Scientific Title:Acronym
A verification study of blood amino acid levels at intake of protein material
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify blood amino acid levels at intake of protein material and the absorption of protein material. To characterize protein derived from test material A by verifying protein utilization and absorption rate compared to existing milk protein (animal) and soy protein (plant).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The time to maximum blood concentration (Tmax) of total amino acid
Key secondary outcomes
1. The incremental area under the curve (IAUC), and the maximum blood concentration (Cmax) of total amino acid, the measured values at each measurement point, and the changes from measurements before consuming the test products
2. IAUC, Tmax, Cmax, the measured values at each measurement point, and the changes from measurements before consuming the test products to each measurement point of branched-chain amino acids (BCAA), essential amino acid (EAA), non-essential amino acid (NEAA), plasma amino acids fraction, and Fischer ratio
3. The measured values of "hunger" and "satiety" at each measurement point
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: Single ingestion (three times)
Test product:
<Test 1> Protein derived from test material A
<Test 2> Soy protein
<Test 3> Milk protein (whey protein)
Intake method:
Add 200 mL of water and the test product to a shaker container, intake after thoroughly stirring. Immediately afterward, add 100 mL of water again to the empty shaker container and intake after thoroughly stirring for total consumption. Then intake 50 mL of water for oral refreshment. (The entire process described above should be conducted over a period of five minutes so that all individuals are at the same pace.)
*The washout period is at least one week.
*The intervention sequence is Test 1 to Test 3.
Interventions/Control_2
Duration: Single ingestion (three times)
Test product:
<Test 1> Soy protein
<Test 2> Milk protein (whey protein)
<Test 3> Protein derived from test material A
Intake method:
Add 200 mL of water and the test product to a shaker container, intake after thoroughly stirring. Immediately afterward, add 100 mL of water again to the empty shaker container and intake after thoroughly stirring for total consumption. Then intake 50 mL of water for oral refreshment. (The entire process described above should be conducted over a period of five minutes so that all individuals are at the same pace.)
*The washout period is at least one week.
*The intervention sequence is Test 1 to Test 3.
Interventions/Control_3
Duration: Single ingestion (three times)
Test product:
<Test 1> Milk protein (whey protein)
<Test 2> Protein derived from test material A
<Test 3> Soy protein
Intake method:
Add 200 mL of water and the test product to a shaker container, intake after thoroughly stirring. Immediately afterward, add 100 mL of water again to the empty shaker container and intake after thoroughly stirring for total consumption. Then intake 50 mL of water for oral refreshment. (The entire process described above should be conducted over a period of five minutes so that all individuals are at the same pace.)
*The washout period is at least one week.
*The intervention sequence is Test 1 to Test 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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Individuals aged >= 20 and < 60
4. Healthy individuals
5. Individuals whose BMI is >= 18.5 kg/m2 and < 25.0 kg/m2 at screening
6. Individuals whose systolic blood pressure is < 140 mmHg and diastolic blood pressure is < 90 mmHg at screening
Key exclusion criteria
1. Individuals who are undergoing treatment or have a history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator
3. Individuals who are undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. Individuals who are taking or using medications (including herbal medicines) or supplements
6. Individuals who are allergic to medicines or foods related to the test product, particularly those allergic to glutathione, soy, or milk
7. Individuals who drink pure alcohol an average of >= 60 g/day a week
8. Individuals who are smokers or have quit smoking within the last year
9. Individuals whose lifestyles or dietary habits are irregular due to working a late-night shift or others
10. Individuals who have food allergies or food intolerances including the test foods and the prescribed food
11. Individuals who have a history of serious diseases of digestive organs, or surgical history of digestive organs
12. Individuals who have developed abdominal pain or gastrointestinal symptoms due to consuming high-protein foods
13. Individuals who have or have a history of a diseases which influence digestion and absorption of nutrients
14. Individuals who are taking steroids, protease inhibitors, or antipsychotics
15. Individuals who are pregnant, lactating, or planning to become pregnant during this study
16. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
17. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
Mitsubishi Corporation Life Sciences Limited
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Corporation Life Sciences Limited
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
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 31 | 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
18
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
| 2025 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 23 | Day |
Last modified on
| 2025 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066251
