Healthy volunteer
Conditions
Interventions
[1]Use 4-layer special three-dimensional mattress [2]Use control products
[1]Use control products [2]Use 4-layer special three-dimensional mattress
Sponsors
Anti-Aging Bank Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese males and females aged 40-65 years [2]Individuals who are healthy and are not received treatment of disease [3]Individuals who are not satisfy quality of sleep [4]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 [5]Dinner was completed 3 hours before bedtime, after that, individuals with no snacking habits until getting up [6]Individuals working on weekdays only 5 days a day during the daytime [7]Individuals whose written informed consent has been obtained [8]Individuals who can come to the designated examination date and receive the examination [9]Individuals judged appropriate for the study by the principal
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products [2]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders [3]Individuals who are suspected, recived treatment of, or have a history of sleep apnea syndrome [4]Individuals who have or are suspected with the night urination, prostatomegaly, or overactive bladder [5]Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc. [6]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.) [7]Individuals with history of gastrointestinal disorders except for appendicitis [8]Individuals with >=25.0kg/m2 BMI [9]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [10]Individuals who have experienced mood disorder or condition deterioration due to blood sampling in the past [11]Individuals deemed sensitive to the test product or highly allergic to foods or medical drugs [12]Individuals who have the possibility of developing seasonal allergic symptoms such as hay fever and the possibility of using medicines (eyedrops, nose drops are acceptable) [13]Individuals who continuously ingest supplements that have effects on blood glucose levels and supplements that contain vitamin C and those who intend to consume during the study period (but not those who can stop taking the intake at the time of consent acquisition) [14]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [15]Individuals whose life style will change during the test period (ex. travel for a long time) [16]Individuals who are or are posslibly, or are lactating [17]Individuals with a scheduled or likely to visit an MRI examination during the period of this study etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Night of the blood glucose level,AUC | — |
Secondary
| Measure | Time frame |
|---|---|
| [1]Sleep-related hormone test (Week 0, Week 2) [2] OSA sleep inventory MA version (Week 0, Week 2) [3]Japanese version of the Pittsburgh Sleep Quality Index (Week 0, Week 2) | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd. Department of Clinical Trial
Outcome results
None listed