Healthy elderly male
Conditions
Sponsors
CPCC Company Limited
National Institutes of Biomedical Innovation, Health and Nutrition
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Japanese men aged 65 to below 75 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 between 50 and 80 kg. 4. Individuals with a body mass index (BMI) of 18.5 kg/m2 or higher and less than 30.0 kg/m2. 5. 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 with known infection with hepatitis B or C virus, HIV, or syphilis, or those who test positive for these infections at screening. 7. Individuals who donated blood or component (200 mL) within the last 1 months. 8. Individuals who donated blood (400 mL) within the last 3 months. 9. Individuals who being collected in total of blood (1200 mL) within the last 12 months and in this study. 10. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expired rate of CO2 release 13CO2 enrichment in breath 13C phenylalanine enrichment in urine Resting energy expenditure measured by indirect calorimetry Rate of 13CO2 excretion in breath derived from oxidation of L-[1-13C]phenylalanine Phenylalanine kinetics Insulin Plasma free amino acids C-peptide Free fatty acids Triglycerides Glucose Glucagon Serum fibroblast growth factor 21 (FGF21) | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed