Single-blind safety study of increasing dose of amino acid component
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000040281
- Lead Sponsor
- International Council on Amino Acid Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 120
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in laboratory test values
- Secondary Outcome Measures
Name Time Method Ratio of incidence on adverse event