Male/female adults
Conditions
Interventions
Consumption of the test food (1 capsule a day) for 4 weeks
Consumption of the placebo food (1 capsule a day) for 4 weeks
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese males and females aged 30 to below 60 years at the time of consent acquisition. 2. Subjects experiencing one or more of the following sleep issues: difficulty falling asleep, waking up during the night, or feeling unrefreshed upon waking in the morning. 3. Members of the health advice application. 4. Subjects who can use an activity tracker during the study period. 5. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: 1. Subjects who regularly consume products advertised for improving sleep, stress, and fatigue more than three times a week and cannot discontinue them from the time of consent acquisition. 2. Subjects taking medications or quasi-drugs (such as sleep aids or nutritional drinks) that may affect the study more than once a week and cannot restrict their use during the study period. 3. Subjects engaging in activities aimed at improving sleep, stress, and fatigue (such as regular medical visits, treatments, or counseling). 4. Subjects who have significant lifestyle changes planned during the study period, such as job changes, moving, or travel lasting more than one week. 5. Perimenopausal women experiencing significant changes in physical condition. 6. Subjects who find it difficult to wear an activity tracker while sleeping. 7. Subjects receiving treatment, medication, or lifestyle guidance for mental disorders, sleep disorders, or chronic fatigue syndrome. 8. Subjects who smoke heavily (not less than 21 cigarettes a day) 9. Subjects who consistently consume alcohol in amounts exceeding moderate drinking (approximately 20 g of pure alcohol per day). 10. Subjects with extremely irregular lifestyle habits. 11. Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. 12. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. 13. Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. 14. Subjects with allergies to medications and/or food. 15. Subjects deemed unsuitable for participation in the trial by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oguri-Shirakawa-Azumi Sleep Inventory, Middle-age and Aged version | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI) Four-item subjective sensation Likert scale Objective activity levels (sleep) | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed