The Effect of a Study Food Product on Sleep
- Conditions
- Male/female adults
- Registration Number
- JPRN-UMIN000053099
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 80
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Oguri-Shirakawa-Azumi Sleep Inventory, Middle-age and Aged version
- Secondary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index (PSQI) Four-item subjective sensation Likert scale Objective activity levels (sleep)