Healthy male/female adults
Conditions
Interventions
Ingestion of the test tablet licking to the subject without chewing, four times a day (every daily meal, and before going to bed, basically).
Ingestion of the placebo tablet licking to the subject wit
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy male/female subjects ranging in age from 30 to 45, living in Tokyo and the surrounding area. (2) Subjects spending a sleepless night (difficulty in falling asleep for not less than 30 min, in waking up perspicuously; and having a nocturnal awakening, a lack of sleeping time). (3) Subjects working for not less than 4 days a week, restricting for not less than 3.5 hours in the daytime. (4) Subjects who can give informed consent to participate in this trial after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects who do not care for a black tea very much. (2) Subjects with smoking habit. (3) Subjects being over-sensitiveness to cold, even during the summer season. (4) Subjects with nasal congestion during this trial. (5) At present, subjects with continuous medical treatment. (6) Subjects having present/previous medical history of serious diseases in liver, kidney, heart, lung, and/or blood. (7) Subjects with a remedy for their sleep disorder. (8) Subjects with high blood pressure--max of above 160 mmHg, min of above 100 mmHg--. (9) Subjects who have any difficulty in refraining from taking steadily in the health-specific/functional/health foods, which might affect their sleep during this trial. (10) Subjects who realized that the subjects themselves must be in a state of menopausal disorder. (11) Subjects planning to go on a trip, or to stay in places except homes. (12) Subjects with any difficulty in refraining from using a smartphone/cellphone/personal computer, an hour before going to bed. (13) Subjects who have any difficulty in refraining from alcohol and/or caffein, after 17 o'clock during this trial. (14) Subjects sleeping together with their family (especially in pre-school children) in a bed time. (15) Pregnant, possibly pregnant, or lactating women. (16) Subjects donated their blood components and/or whole blood (200 mL) within a month to this trial. (17) Males donated their whole blood (400 mL) within the last three months to this trial. (18) Females donated their whole blood (400 mL) within the last four months to this trial. (19) Males being collected in total of their blood (1200 mL) for the last twelve months plus in this trial. (20) Females being collected in total of their blood (800 mL) for the last twelve months plus in this trial. (21) Subjects being under the other clinical tests, or took part in those within a month before this trial. (22) Others as ineligible for participation, determined by the principal investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. OSA sleep inventory 2. Pittsburg sleep questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Stress Check List 30 2. Active mass 3. Self-rating Depression Scale 4. Mental age 5. Brain execution 6. Chromogranin A 7. Oxytocin 8. sIgA 9. Cortisol | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed