healthy person
Conditions
Interventions
Sponsors
Clinical Creative Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Those whose score on the Athens Insomnia Scale is 6 points or higher. 2. Those who are able to come to the examination site on the designated date. 3. Persons who are willing to give written consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1. Those who are currently receiving treatment (including medication) for any disease. 2. Those who have been diagnosed with sleep disorders such as insomnia or sleep apnea, and are taking drugs such as sleep inducers or insomnia medications (including OTC drugs as well as prescription drugs), or are receiving treatment with CPAP or mouthpieces, etc. 3. Those who have been diagnosed and treated for allergic diseases such as atopic dermatitis, asthma, allergic rhinitis, or nocturia. 4. Consume foods for specified health use, foods with functional claims, or other foods/beverages with possible functional properties on a regular basis. 5. Those whose BMI exceeds 30 (severely obese) 6. Those who are mainly in charge of taking care of those who need nursing care or infants. 7. Those who work late at night, shift work, or heavy labor. 8. Pregnant, lactating, or intending to become pregnant. 9. Those who cannot sleep alone on a single bedding (futon or bed, etc.) during the research period. 10. who sleeps less than 6 hours per night (calculated based on their reported normal bedtime and waking time). Items that cannot be listed in the Exclusion Criteria column are listed in Other Relevant Information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluate the relationship between the concentration of cortisol in the saliva of each subject and the presence or absence of the test food intake. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Calculate the 3-day average of each of the subjective sleep quality parameters scored by the MA version of the OSA Sleep Questionnaire, and evaluate the relationship with the presence or absence of the test food intake by comparing these average values. 2. Each subject's scores on the Brief Stress Level Checklist, the General Mood State (POMMS2), the Health-related Quality of Life Scale (SF-8), the Fatigue Rating Scale (CFS), the Depressed Mood Scale (DASS), the Epworth Sleepiness Scale (ESS), and the Athens Insomnia Scale (AIS) will be compared to determine the relationship of test food intakeThe relationship between the presence and absence of the test food intake will be evaluated. | — |
Countries
Japan
Contacts
Public ContactKazuhiro Ohno
Clinical Creative Co., Ltd. Pharmaceutical Development Division
Outcome results
None listed