Healthy Volunteers
Conditions
Interventions
Intake of prescribed meals and load food
Sponsors
Otsuka Pharmaceutical Co.,Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Individuals who voluntarily give written informed consent. 2) Individuals who are healthy adult males aged 20-80. 3) Individuals who can participate in the intake of load food and prescribed meals, blood samplings, urine samplings, fecal samplings, keeping rest as scheduled. 4) Individuals who have smartphone which can install applications, and who agree with terms of service of wearable device and the applications.
Exclusion criteria
Exclusion criteria: 1) Individuals who are judged to be ineligible for this study by the investigator based on the results of pre-screening diagnosis. 2) Individuals who are judged to be ineligible for this study by the investigator due to having a past or present medical history of gastrointestinal, cardiovascular, endocrine or other disorders and regularly using any medications for disease treatment. 3) Individuals who have difficulty with wearing wearable device. 4) Individuals who will stay overnight overseas between the test period and the post-observation period. 5) Individuals who have food allergies. 6) Individuals who donated blood within last 12 weeks prior to pre-screening diagnosis. 7) Individuals who are participating in other clinical studies or who are planning to participate in other clinical studies. 8) Individuals who are judged to be ineligible for this study with other concerns by the investigator, subinvestigator or study director.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| index of protein turnover | — |
Countries
Japan
Contacts
Public ContactMoe Yamamoto
Otsuka Pharmaceutical Co., Ltd. Otsu Nutraceuticals Research Institute
Outcome results
None listed