Healthy Japanese subjects
Conditions
Interventions
28 days ingestion of test food
Sponsors
ROHTO Pharmaceutical co., ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Subjects who are stressed and dissatisfied with their sleep. 2. Subjects who have a holidays on Saturdays and Sundays and do not work in shifts.
Exclusion criteria
Exclusion criteria: 1. Subjects who smoke 2. Those undergoing treatment for chronic diseases 3. Subjects who have a serious disease of the heart, liver, kidneys, digestive organs, etc., or a current or history of mental illness 4. Subjects who routinely use or consume medicines such as antihistamines and antiallergic agents, health foods and supplements (theanine, glycine, etc. claimed to have effects on sleep and stress) that may affect the test results 5. Subjects who have a history or current illness of allergies that may affect the test results 6. Subjects who have BMI of 25 kg/m2 or more 7. Subjects who wake up more than three times between going to bed and waking up because of urination, itching, nasal congestion, etc. 8. Subjects who are extremely irregular, such as having dinner after 10:00 p.m. on more than three days in a week 9. Subjects who do not have a routine timing for bathing 10. Subjects who drink excessive amounts of alcohol (20g or more) on a daily basis 11. Subjects who share a bedroom with preschool children or pets 12. Subjects who need to get up frequently during the night, for example, because they live with children or people who need nursing care 13. Subjects who are judged as ineligible to participate in the study by principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in scores (by factor) OSA sleep inventory MA version | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in scores (by item, and total) of OSA sleep inventory MA version (item, total) 2. Changes in sleep-related data obtained from sleep measurement devices 3. Changes in salivary cortisol levels 4. Changes in the amount of IgA in saliva 5. VAS (for stress) 6. Questionnaire | — |
Countries
Japan
Contacts
Public ContactYukiko Sekii
ROHTO Pharmaceutical co., ltd. Internal Medicine & Food Development Division
Outcome results
None listed