Healthy volunteer
Conditions
Sponsors
Anti-Aging Bank Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese male and females aged 50-65 years [2]BMI is 25.0kg/m2 or more and less than 30.0kg/m2 [3]Individuals who are aware of mild sleep disorders such as waking up in the middle of the night (midway awakening), waking up early in the morning (early morning awakening), and not feeling well asleep (deep sleep disorder) [4]Individuals who work 3 to 5 days a week during the day and are on weekends and public holidays [5]Individuals whose sleeping hours are over 4 hours from lights-out to rising and time of lights-out and rising is regular and bedtime is every 24th hours [6]Individuals who are sleeping alone [7]Individuals who do not have a habit of drinking alcohol [8]Individuals whose written informed consent has been obtained [9]Individuals who can come to the designated examination date and receive the examination [10]Individuals judged appropriate for the study by the principal
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products [2]Individuals who are currently ingesting or applying drugs [3]Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc. [4]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders [5]Individuals who are suspected, recived treatment of, or have a history of sleep apnea syndrome [6]Individuals who have or are suspected with the night urination, Prostate hypertrophy, or overactive bladder [7]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.) [8]Individuals with a history of comorbidities and serious gastrointestinal disorders [9]Individuals with severe constipation and diarrhea on a daily basis [10]Individuals who cannot stop drinking during the test period [11]smoker [12]Individuals who have a habit of continuing to take functional foods, foods for specified health use, health foods, supplements in the past month, and those who plan to take them during the test period [13]Individuals who donated 200 mL of blood in the past month or more than 400 mL within 3 months [14]Individuals who may change their lifestyle during the test period, or who may have difficulty using the test mat due to travel, etc. [15]Individuals who are currently participating in other human clinical trials, those who have not passed 3 months since participating in other human clinical trials [16]Individuals who are pregnant, breastfeeding or may become pregnant [17]Individuals who are judged by the investigator to be inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut flora test (T-RFLP flora analysis)(0W,8W), Body composition test(0W,4W,8W) | — |
Secondary
| Measure | Time frame |
|---|---|
| OSA sleep inventory MA version,Japanese version of the Pittsburgh Sleep Quality Index,Anti-Aging QOL Common Questionnaire(AAQol)(0W,4W,8W),Cognitrax(0W,8W),IGF-1,DHEA-s,cortisol(0W,4W,8W),ABeta-40,ABeta-42,ApoA1,C3(0W,8W) | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd. Department of Clinical Trial
Outcome results
None listed