Unique ID issued by UMIN | UMIN000050128 |
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Receipt number | R000057106 |
Scientific Title | Effects of consumption of the test food on the elevation of blood amino acid levels |
Date of disclosure of the study information | 2023/01/25 |
Last modified on | 2023/06/21 11:33:09 |
Effects of consumption of the test food on the elevation of blood amino acid levels
Effects of consumption of the test food on the elevation of blood amino acid levels
Effects of consumption of the test food on the elevation of blood amino acid levels
Effects of consumption of the test food on the elevation of blood amino acid levels
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To measure blood amino acid levels as verification of the protein absorption efficiency of the test food
Bio-equivalence
Confirmatory
Pragmatic
Not applicable
1. The area under the curve (AUC) of plasma amino acids fraction, Fischer ratio, total amino acid, branched-chain amino acids (BCAA), essential amino acid (EAA), and non-essential amino acid (NEAA)
1. The time to maximum blood concentration (Tmax) of plasma amino acids fraction, Fischer ratio, total amino acid, BCAA, EAA, and NEAA
2. The maximum blood concentration (Cmax) of plasma amino acids fraction, Fischer ratio, total amino acid, BCAA, EAA, and NEAA
3. The measured values of plasma amino acids fraction, Fischer ratio, total amino acid, BCAA, EAA, and NEAA at each measurement point
4. The changes of plasma amino acids fraction, Fischer ratio, total amino acid, BCAA, EAA, and NEAA from pre-consumption to each measurement point
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
Institution is not considered as adjustment factor.
YES
3
Treatment
Food |
Duration: Single ingestion (one term)
Test food: OIKOS (plain/sweetened)
Administration: Take one cup of test food (113 g) within 15 minutes after pre-consumption measurement
Duration: Single ingestion (one term)
Test food: Commercially available milk
Administration: Drink 300 mL of test food within 15 minutes after pre-consumption measurement
Duration: Single ingestion (one term)
Test food: Commercially available high-protein beverage
Administration: Drink 140 mL of test food within 15 minutes after pre-consumption measurement
18 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Adults
4. Healthy subjects
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. Subjects who are currently taking medications (including herbal medicines) and supplements
6. Subjects who are allergic to medicines and/or the test food related products
7. Subjects whose lifestyles are irregular due to working a late-night shift or others
8. Subjects who have food allergies and/or food intolerances. Particularly, subjects who have lactose intolerance.
9. Subjects who have or are undergoing medical treatment for diseases which influence digestion and absorption of nutrients
10. Subjects who are taking steroids, protease inhibitors, or antipsychotics
11. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
12. Subjects who suffer from COVID-19
13. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
14. Subjects who are judged as ineligible to participate in this study by the physician
18
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
DANONE JAPAN CO.,LTD.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
IRB@takara-clinic.com
NO
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)
2023 | Year | 01 | Month | 25 | Day |
Unpublished
21
Completed
2023 | Year | 01 | Month | 18 | Day |
2023 | Year | 01 | Month | 18 | Day |
2023 | Year | 01 | Month | 25 | Day |
2023 | Year | 04 | Month | 02 | Day |
2023 | Year | 01 | Month | 25 | Day |
2023 | Year | 06 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057106
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