Healthy Volunteer
Conditions
Interventions
4-weeks intake of the test food without shift work
4-weeks intake of the placebo food without shift work
4-weeks intake of the test food with shift work
4-weeks intake of the placebo food with shift w
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Jeneral foundation Tohoku-seishin-hokenkai Aoba hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Persons who have obtained written consent for participation in the research. 2)Healthy men and women. 3)Persons who have undergone a physical examination within one year. 4)Persons who can take test foods, etc. and maintain rest according to the schedule instructed by researchers.
Exclusion criteria
Exclusion criteria: 1)Persons who have or had disorder in digestive, circulatory or endocrine system and who are estimated inappropriate to this study. 2)Persons who have allergy. 3)Others who are judged unsuitable as subjects by principal investigator or principal researcher (e.g., sleep apnea syndrome).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep-related indices (3DSS and sleep duration, awake time, sleep score, heart rate during sleep, autonomic function) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Discomfort due to wearing masks, fatigue and stress at work, number of errors at work (Safety evaluation) General physical findings (subjective symptoms, objective findings), vital signs (weight, body temperature, blood pressure, pulse rate), frequency of adverse events | — |
Countries
Japan
Contacts
Public ContactTsubasa Mizokami
Otsuka Pharmaceutical Co., Ltd. Saga Nutraceuticals Research Institute
Outcome results
None listed