Healthy adults
Conditions
Interventions
Intake of a food containing plant extract oncea day for one weeks
Intake of a placebo food that does not containplant extract once a day for one weeks
Sponsors
WELLPHARMA Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Healthy men and women. -Subjects who are aware of problems or issues with sleep. -Subjects who can make self-judgment and arevoluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: -Currently receiving treatment (including medication) for any disease -Subjects who have been diagnosed as having a sleep disorder such as insomnia or sleep apnea syndrome, and are taking drugs such as sleep inducers or insomnia medications (including OTC drugs as well as prescription drugs),or receiving treatment with CPAP or mouthpieces, etc. -Those who regularly consume foods for specified health uses, foods with functional claims, or other foods/beverages with possible functional properties. -Subjects with a BMI over 30 (severely obese) -Subjects who are primarily responsible for the care of persons in need of nursing care or infants. -All who are unable to sleep alone on a single bedding (e.g., futon or bed) during the study period. -A person who is not able to comply with the gentle sleep control (going to bed within Plus or minus 2 hours of the reported bedtime and waking up within Plus or minus 2 hours of the reported waking time) during the test period. -Candidates who cannot avoid drinking alcohol and consuming caffeinated beverages (sencha, black tea, coffee, caffeinated beverages, etc.) after 6:00 p.m. during the EEG measurement period and the day before the measurement period. -Consistently consumes more than adequate alcohol (average daily alcohol consumption of approximately 20 g of pure alcohol or less). -Consentee who is unable to complete the EEG measurement and the sleep diary/OSA sleep questionnaire according to the schedule. -Participants who have participated or will participate in other clinical trials in the month prior to the date of consent -Other individuals who are deemed by the physician to be inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indexes on sleeping | — |
Secondary
| Measure | Time frame |
|---|---|
| Indexes on sleeping Questionnaire | — |
Countries
Japan
Contacts
Public ContactYoko Shimada
Clinical Creative Co.,Ltd. Pharmaceuticals Division
Outcome results
None listed