UMIN ID: UMIN000054129
Registered date:12/04/2024
Preliminary Clinical Trial on Leucine Requirement in Japanese Adult Men Using the Indicator Amino Acid Oxidation (IAAO) Method
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Healthy adult male |
| Date of first enrollment | 2024/04/15 |
| Target sample size | 2 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Consumption of the test food A Consumption of the test food B |
Outcome(s)
| Primary Outcome | Expired rate of CO2 release 13CO2 enrichment in breath 13C phenylalanine enrichment in urine Resting energy expenditure |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 60years-old |
| Gender | Male |
| Include criteria | |
| Exclude criteria | 1. Subjects who are aware of a weight change of more than 5 kg in the month prior to obtaining consent. 2. Subjects with excessive alcohol intake. 3. Subjects suffering from diseases that affect protein and amino acid metabolism, such as diabetes, cancer, liver disease, kidney disease, HIV, etc. 4. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. 5. Subjects with allergies to medications and/or food. 6. Subjects who donated blood or component (200 mL) within the last 1 months. 7. Subjects who donated blood (400 mL) within the last 3 months. 8. Subjects who being collected in total of blood (1200 mL) within the last 12 months and in this study. 9. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator. |
Related Information
| Primary Sponsor | CPCC Company Limited |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | The International Council on Amino Acid Science |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masanori Numa |
| Address | 4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan Japan 103-0021 |
| Telephone | 03-6225-9001 |
| cpcc-contact@cpcc.co.jp | |
| Affiliation | CPCC Company Limited Clinical Planning Department |
| scientific contact | |
| Name | Terutaka Kodama |
| Address | c/o MAINICHI ACADEMIC FORUM, Inc. Palace side Building 1-1-1 Hitotsubashi, Chiyoda-ku Tokyo Japan |
| Telephone | 03-6267-4550 |
| secretariat01@e-icaas.org | |
| Affiliation | The International Council on Amino Acid Science Executive managing director |