N/A (healthy adults)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: [1]Men and Postmenopausal women aged between 45 and 64 at the time of informed consent [2]Individuals who are healthy and have no chronic physical disease including skin disease [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 venue for this study and be inspected. [10]Individuals judged appropriate for this study by responsible doctor
Exclusion criteria
Exclusion criteria: Individuals (who) [1] contract disease and are under treatment [2] under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders [3] have a history of and/or contract serious diseases (eg, Uterine disease,liver disease, kidney disease, heart disease, lung disease, blood disease) [4] have a history and/or contract digestive disease [5] receiving hormone replacement therapy [6] are suspected, recived treatment of, or have a history of sleep apnea syndrome [7] have or are suspected with the night urination or overactive bladder [8] receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc. [9] BMI are 30 or more [10] have a habit to use functional foods and/or are planning to use those foods during test periods [11] donated 200 mL of blood in the past month or more than 400 mL within 3 months [12] with possible changes of life style during test periods [13] are participating and/or had participated in other clinical studies within the last 3 months [14] are judged as not appropriate to this study by a responsible doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxytocin in saliva Urinary oxytocin Urinary melatonin Urinary stress marker 6-component analysis (dopamine, serotonin, GABA, 5-hydroxyindoleacetic acid, homovanillic acid, vanillylmandelic acid) | — |
Secondary
| Measure | Time frame |
|---|---|
| OSA sleep inventory MA version POMS2 State-Trait Anxiety Inventory-Form JYZ | — |
Countries
Japan
Contacts
TES Holdings Co., Ltd. Department of Clinical Trial