Healthy adults
Conditions
Interventions
Sponsors
Other
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Age: 20-34, healthy male 2) BMI: 18.5 kg/m2-24.9 kg/m2 3) Subjects who giving informed consent.
Exclusion criteria
Exclusion criteria: 1) Subjects with a serious medical history, or with a history of disorders of the digestive system, circulatory system (e.g., heart failure), endocrine system, etc. Subjects who have been judged to be inappropriate for the study by the principal investigator. 2) Subjects who have a history of gastrointestinal resection surgery, excluding appendectomy. 3) Subjects who are currently taking medication or being treated by a physician. 4) Subjects who must be scheduled to receive medical treatment or medication during the study period. 5) Subjects who plan to consume health foods or supplements other than the food under study after consent. 6) Subjects who are unable to consume the test food due to preference or allergy. Subjects who may have allergies related to the test food. 7) Heavy drinkers of alcohol and heavy smokers. 8) Subjects who have difficulty in taking blood samples. 9) Subjects who donated blood over 200mL in the past 4 weeks or over 400mL in the past 12 weeks. 10) Subjects who currently or will be participating in another clinical research study during the study period. 11) Subjects who have irregular sleep or eating habits due to night work or insomnia. 12) Subjects who are engaged in strenuous physical activity. 13) Subjects judged as unsuitable for the study by the responsible doctor for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to maximum concentration (Tmax) of active ingredients | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood concentration of active ingredients at each time point after ingestion of the test food Area Under the Curve(AUC) and Maximum serum concentration(Cmax) of active ingredients | — |
Countries
Japan
Contacts
Public ContactReiko Naito
Kenkoin Medical Corporation Foundation Kenkoin Clinic
Outcome results
None listed