Male adults
Conditions
Interventions
Sponsors
Yakult Honsha Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Healthy males aged 20 to below 60 years at the time of consent acquisition. 2.Office workers 3.Subjects whose average sleep duration is over 6 hours 4.Subjects whose day-to-day variability in bedtime and wake-up time on weekdays is within 2 hours. 5.Subjects who can go to bed before midnight on the day before the test. 6.Subjects who commute by walking or biking (with the duration of approx. 5 to 30 minutes) 7.Subjects who give written informed consent, after receiving a detailed explanation of the study protocol and understanding the provided information.
Exclusion criteria
Exclusion criteria: 1.Subjects with a history or current diagnosis of mental disorders, chronic fatigue syndrome, sleep disorders, brain injury, brain dysfunction, learning disabilities, or dementia. 2.Subjects with a history or current diagnosis of diabetes, liver disease, kidney disease, heart disease, respiratory disease, diseases affecting adrenal cortex hormone secretion, or other metabolic diseases. 3.Subjects who are currently undergoing medication treatment. 4.Subjects who have smoking habits. 5.Subjects who daily take excessive alcohol. 6.Subjects who are unable to refrain from exercise on the test day (excluding physical activity related to commuting) until the end of blood sampling. 7.Subjects whose sleep environment may change significantly due to long-term business trips or travel during the study period. 8.Subjects who have a participation in other clinical trials within the last 4 weeks or are intended to participate. 9.Subjects who have allergies to medications and/or food. 10.Subjects who have been considered ineligible for participation in the trial by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of proteins downstream of signaling pathways stimulated by the test food component | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of gastrointestinal hormones Correlation between plasma concentrations of proteins and gastrointestinal hormones that showed significant expression changes in the primary endpoints Changes in the plasma proteome associated with the ingestion of the test food component | — |
Countries
Japan
Contacts
Public ContactKazunori Matsuda
Yakult Honsha Co., Ltd. Food Research Department
Outcome results
None listed