healthy person
Conditions
Interventions
During the intervention period, Group A (30 subjects) will each consume their assigned test product daily after breakfast.They will also record their intake status and various subjective symptoms in a
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. The average values of the parameters related to the quantity and quality of sleep obtained from the results of EEG sleep easurements for each subject for each of the three nights will be calculated, and the relationship between the intake of the test food and the subjects will be evaluated according to these average values. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The average values of the subjective sleep quality parameters scored by the MA version of the OSA Sleep Questionnaire will be calculated for each of the 3 days, and the relationship with the presence or absence of the test food intake will be evaluated by comparing these average values. 2. The scores of each subject 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) were compared with those of the subjects who had consumed the test food.The 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