Healthy adult
Conditions
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy males and females from 20 to 59 years of age (2) Subjects whose average score for the 5 factors of OSA-MA in the pre-test is less than 50 (3) Subjects who fully understand the purpose and content of the study and voluntarily agree to participate in the study
Exclusion criteria
Exclusion criteria: (1)Subjects who cannot eat one pack of test food every day (2)Subjects who have irregular sleeping environment, sleeping time and waking time on weekdays (3)Subjects who are a day shift worker or is involved in manual labor such as heavy object transportation and subjects whose working days and non- working days are irregular (4)Subjects who have difficulty in carrying out OSA-MA records (5)Subjects who are in the habit of consuming alcohol on a daily basis (6)Subjects who have environment that disturbs sleep (7)Subjects who have the disease requiring regular medication (8)Subjects who are under treatment or a history of sleep apnea syndrome or are strongly suspected of having sleep apnea syndrome (9)Subjects who have or are suspected of having nocturia, benign prostatic hyperplasia, or an overactive bladder (10)Subjects who have history of mental illness, chronic fatigue syndrome, Hypertension, diabetes, or dyslipidemia (11)Subjects who are under treatment or have a history of serious diseases (e.g., liver disease, kidney disease, heart disease, lung disease, or blood disease) (12)Subjects who have possibilities for emerging allergy related to a food allergy (13)Subjects who have pollinosis that needs taking medicine (14)Subjects who Have a BMI of 30 or more (15)Subjects who have possibilities for changing lifestyle during the study period (16)Subjects who plan to become pregnant or breastfeed during the study period (17)Subjects who have participated in other human clinical trials, or subjects who have participated in other clinical trials within one month prior to obtaining consent to participate in this study (18)Subjects who are judged to be inappropriate as study subjects based on their answers to the lifestyle questionnaire (19)Subjects who are judged to be inappropriate as study subjects based on the results of the pre-test (20)Subjects deemed inappropriate as study subjects by the principal investigator or the investigator for other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OSA-MA | — |
Secondary
| Measure | Time frame |
|---|---|
| AIS, PSQI-J, POMS2-AS scores, serum DHEA-S, serum cortisol, the ratio of serum DHEA-S and serum cortisol | — |
Countries
Japan
Contacts
Public ContactYoshimi Bansho
EP Mediate Co., Ltd. Development Department Trial Planning Section
Outcome results
None listed