Unique ID issued by UMIN | UMIN000040281 |
---|---|
Receipt number | R000045956 |
Scientific Title | Single-blind safety study of increasing dose of amino acid component |
Date of disclosure of the study information | 2020/05/03 |
Last modified on | 2023/07/20 15:17:11 |
Single-blind safety study of increasing dose of amino acid component
Single-blind safety study of increasing dose of amino acid component
Single-blind safety study of increasing dose of amino acid component
Single-blind safety study of increasing dose of amino acid component
Japan |
Healthy subjects
Adult |
Others
NO
Confirmation of safe intake of test food by ingesting test food (low to 4 doses) for 30 weeks in 30 healthy adult males and evaluating the occurrence of adverse events after ingestion of test food
Safety
Changes in laboratory test values
Ratio of incidence on adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Prevention
Food |
Test food A, Test food B, Test food C, Test food D
Treatment1, Washout, Treatment2, Washout, Treatment3, Washout, Treatment4
20 | years-old | <= |
60 | years-old | > |
Male
1. Healthy men aged between 20 and 60 at the time of consent
2. Subjects who gave written consent after fully understanding the purpose and content of this study
1.Subjects who have or are likely to ingest the drug continuously during the intake period of the test food
2.Subjects taking or scheduled to take supplements containing amino acids as the main component from the time of participation in the study to the end of the study food intake period
3.Subjects who are participating in other human trials as test subjects, or within 4 weeks after the end of the trials in which they participated, or subjects scheduled to participate during the main study period
4.Subjects who meet any of the following
1) Subjects with heart, liver, or kidney disease (including cases of complications of other diseases)
2) Subjects with respiratory disease
3) Subjects with a history of cardiovascular disease
4) Subjects with diabetes
5) Subjects with intestinal disorders
6) Subjects who are undergoing treatment or have a history of treating serious diseases such as cancer and tuberculosis
Subjects with respiratory disease
5. Subjects with pharmaceutical or food allergies
6. In addition to the above, those who are judged by the investigator to be unsuitable for the test
120
1st name | Smriga |
Middle name | |
Last name | Miro |
International Council on Amino Acid Science
Secretariat Office
104-0032
3F, 3-11-8 Hatchobori Chuo-ku, Tokyo 104-0032, JAPAN
03-3537-7021
secretariat01@e-icaas.org
1st name | Makoto |
Middle name | |
Last name | Terashima |
Oneness Support Co., Ltd.
Clinical Trial Division
530-0044
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
06-4801-8917
mterashima@oneness-sup.co.jp
International Council on Amino Acid Science
International Council on Amino Acid Science
Other
Miura Clinic, Medical Corporation Kanonkai IRB
Higashitenma building 9F, 1-7-17, Higashitenma,Kita-ku, Osaka, Japan
06-6135-5200
mterashima@miura-cl.jp
NO
医療法人花音会みうらクリニック(大阪市)
2020 | Year | 05 | Month | 03 | Day |
Unpublished
Completed
2020 | Year | 02 | Month | 19 | Day |
2020 | Year | 02 | Month | 20 | Day |
2020 | Year | 05 | Month | 04 | Day |
2021 | Year | 03 | Month | 31 | Day |
2020 | Year | 05 | Month | 01 | Day |
2023 | Year | 07 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045956
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |