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Clinical Trial on Leucine Requirement in Japanese Adult Men Using the Indicator Amino Acid Oxidation (IAAO) Method

Clinical Trial on Leucine Requirement in Japanese Adult Men Using the Indicator Amino Acid Oxidation (IAAO) Method - Clinical Trial on Leucine Requirement in Japanese Adult Men Using the Indicator Amino Acid Oxidation (IAAO) Method

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058025
Enrollment
6
Registered
2025-06-01
Start date
2025-06-02
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 adult male

Interventions

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Japanese men aged 20 to below 49 years at the time of consent acquisition. 2. Individuals who have a habit of consuming three meals per day. 3. Individuals whose body weight at the screening examination is 70 kg with a tolerance of plus or minus 2.5 kg. 4. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.

Exclusion criteria

Exclusion criteria: 1. Individuals who are aware of a weight change of more than 5 kg in the month prior to obtaining consent. 2. Individuals with excessive alcohol intake. 3. Individuals suffering from diseases that affect protein and amino acid metabolism, such as diabetes, cancer, liver disease, kidney disease, HIV, etc. 4. Individuals with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. 5. Individuals with allergies to medications and/or food. 6. Individuals who donated blood or component (200 mL) within the last 1 months. 7. Individuals who donated blood (400 mL) within the last 3 months. 8. Individuals who being collected in total of blood (1200 mL) within the last 12 months and in this study. 9. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Expired rate of CO2 release 13CO2 enrichment in breath 13C phenylalanine enrichment in urine Resting energy expenditure

Countries

Japan

Contacts

Public ContactMasanori Numa

CPCC Company Limited Clinical Planning Department

cpcc-contact@cpcc.co.jp03-6225-9001

Outcome results

None listed

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