Healthy male/female adults
Conditions
Interventions
Consumption of the test food with water/lukewarm to the subjects, two drops a day for 4 weeks.
Consumption of the placebo food with water/lukewarm to the subjects, two drops a day for 4 weeks.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy male/female subjects ranging in age from 20 to 64 at informed consent. (2) Subjects having the habit of going to bed by 24 o'clock. (3) Subjects with unsatisfactory sleep. (4) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: Subjects - - (1) taking in sleep-affecting foods, not less than three times a week, (2) who will take medicines which might affect the test (e.g., sleeping pill) during the test period, (3) with not less than 30.0 kg/m2 of BMI, (4) with sleep-apnea syndrome, (5) with previous medical history of sleep disorder, (6) with a continuous medical treatment for sleep disorder, (7) who are now under medical treatment for mental disorders, or have been diagnosed as depression with a strong sense of stress and fear. (8) with an overnight trip during the test period, (9) with extremely irregular dietary habit/life rhythm, (10) with a serious sleep-affecting rhinitis, (11) with excessive alcohol intake, (12) sleeping with their family in the same room, and might be woken up by the family during sleep, (13) with medical history of serious diseases, (14) with pregnancy, possibly one, or lactating, (15) with drug/food allergy, (16) being under another clinical test (medicine or health food), or participated in that within the last 4 weeks, or will join that after the consent, (17) who donated their blood components or blood (200 mL) within the last month, (18) who donated his blood (400 mL) within the last 3 months, (19) who donated her blood (400 mL) within the last 4 months, (20) being collected in total of his blood (1200 mL) within the last 12 months and in this study, (21) being collected in total of her blood (800 mL) within the last 12 months and in this study, (22) being determined as ineligible for participation by the principal/sub investigator - - .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oguri-Shirakawa-Azumi sleep inventory ver. MA | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The Profile of Mood States Second Edition (short ver.) 2. Pittsburgh Sleep Quality Index | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed