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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000040281
Enrollment
120
Registered
2020-05-03
Start date
2020-05-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy subjects

Interventions

Test food A, Test food B, Test food C, Test food D Treatment1, Washout, Treatment2, Washout, Treatment3, Washout, Treatment4

Sponsors

International Council on Amino Acid Science
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Changes in laboratory test values

Secondary

MeasureTime frame
Ratio of incidence on adverse event

Countries

Japan

Contacts

Public ContactMakoto Terashima

Oneness Support Co., Ltd. Clinical Trial Division

mterashima@oneness-sup.co.jp06-4801-8917

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026