Unique ID issued by UMIN | UMIN000054129 |
---|---|
Receipt number | R000061551 |
Scientific Title | Preliminary Clinical Trial on Leucine Requirement in Japanese Adult Men Using the Indicator Amino Acid Oxidation (IAAO) Method |
Date of disclosure of the study information | 2024/04/12 |
Last modified on | 2024/05/20 17:16:11 |
Preliminary Clinical Trial on Leucine Requirement in Japanese Adult Men Using the Indicator Amino Acid Oxidation (IAAO) Method
Preliminary Clinical Trial on Leucine Requirement in Japanese Adult Men Using the Indicator Amino Acid Oxidation (IAAO) Method
Preliminary Clinical Trial on Leucine Requirement in Japanese Adult Men Using the Indicator Amino Acid Oxidation (IAAO) Method
Preliminary Clinical Trial on Leucine Requirement in Japanese Adult Men Using the Indicator Amino Acid Oxidation (IAAO) Method
Japan |
Healthy adult male
Adult |
Others
NO
To confirm the procedures of the studies for evaluating L-leucine requirement by the International Council on Amino Acid Science (ICAAS)
Others
Amino acid requirement
Expired rate of CO2 release
13CO2 enrichment in breath
13C phenylalanine enrichment in urine
Resting energy expenditure
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Dose comparison
2
Prevention
Food |
Consumption of the test food A
Consumption of the test food B
20 | years-old | <= |
60 | years-old | > |
Male
1. Japanese men aged 20 to below 60 years at the time of consent acquisition.
2. Subjects who have a habit of consuming three meals per day.
3. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
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.
2
1st name | Terutaka |
Middle name | |
Last name | Kodama |
The International Council on Amino Acid Science
Executive managing director
100-0003
c/o MAINICHI ACADEMIC FORUM, Inc. Palace side Building 1-1-1 Hitotsubashi, Chiyoda-ku Tokyo
03-6267-4550
secretariat01@e-icaas.org
1st name | Masanori |
Middle name | |
Last name | Numa |
CPCC Company Limited
Clinical Planning Department
103-0021
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
03-6225-9001
cpcc-contact@cpcc.co.jp
CPCC Company Limited
The International Council on Amino Acid Science
Self funding
Institutional Review Board of Chiyoda Paramedical Care Clinic
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
03-6225-9005
IRB@cpcc.co.jp
NO
2024 | Year | 04 | Month | 12 | Day |
Unpublished
2
No longer recruiting
2024 | Year | 03 | Month | 18 | Day |
2024 | Year | 03 | Month | 15 | Day |
2024 | Year | 04 | Month | 15 | Day |
2024 | Year | 06 | Month | 10 | Day |
2024 | Year | 04 | Month | 12 | Day |
2024 | Year | 05 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061551