Healthy volunteers
Conditions
Interventions
Sponsors
Japan Preventive Medicine Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females whose age of 20 years or more and less than 65 years 2) Subjects who are aware of impaired sleep quality 3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects receiving a medical treatment for sleep disorders 2) Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 3) Subjects receiving a medical treatment for chronic diseases such as diabetes, hypertension and dyslipidemia 4) Subjects who take regularly pharmaceuticals, quasi-drugs, supplements or health foods which have an influence on study 5) Subjects who have the possibility of developing allergic symptoms by the test food 6) Subjects who live with their infants less than 1 year old 7) Subjects who sleep with others in a bedroom 8) Subjects whose lifestyles are irregular because of night shift or others 9) Subjects who wake up for urination 2 times or more during nocturnal sleep 10) Subjects who drink a lot (Subjects whose pure alcohol intake per day is 60 g or more) 11) Subjects whose body mass index (BMI) is 25 kg/m2 or more 12) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 13) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 14) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 15) Subjects deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| electroencephalogram during sleep | — |
Secondary
| Measure | Time frame |
|---|---|
| activity tracker, OSA sleep inventory MA version, St. Mary's Hospital Sleep Questionnaire, Japanese version of Karolinska Sleepiness Scale, VAS, autonomic nervous function evaluation, work performance evaluation and urinalysis | — |
Countries
Japan
Contacts
Public ContactTadakazu Takigami
Japan Preventive Medicine Inc. Product Development Department
Outcome results
None listed