Male/female adults
Conditions
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 20 to below 60 years at the time of consent acquisition. 2. Subjects whose body mass index (BMI) is under 30 kg/m 2 . 3. Subjects who are aware of experiencing daily stress. 4. Subjects whose work schedule is typically Monday to Friday with weekends off (including those who have one weekday and one weekend day off). 5. Subjects who habitually go to bed by 24:00. 6. Subjects who are habitually dissatisfied with their sleep. 7. 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 Food for Specified Health Uses (FOSHU), Foods with Functional Claims, or health supplements (including those containing GABA, L-theanine, citric acid, etc.) that may affect stress, sleep, or intestinal health, three or more times per week and cannot stop consuming them from the time of consent. 2. Subjects who are taking medications (including antibiotics, intestinal regulators, laxatives, sleep aids, etc.) that may affect stress, sleep, or intestinal health, and cannot restrict their use from the time of consent. 3. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials. 4. Subjects with severe rhinitis or hay fever that affects sleep. 5. Subjects diagnosed with dry mouth. 6. Subjects who cannot abstain from alcohol from the start of the pre-observation period. 7. Subjects with excessive alcohol intake. 8. Subjects who have smoking habit. 9. Subjects with irregular lifestyles due to shift work, night work, or highly variable workloads. 10. Subjects planning major lifestyle changes from the time of consent acquisition. 11. Subjects with nocturia (two or more times per night). 12. Subjects without an environment where they can use bedding alone. 13. Subjects living in an environment where their sleep may be involuntarily disturbed (such as living with caregivers, infants, or pets). 14. Subjects with a history or current diagnosis of depression or other mental disorders. 15. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. 16. Females who are pregnant or lactating, and females who could become pregnant from the time of consent acquisition. 17. Subjects with allergies to medications and/or food.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stress Levels (measured by Stress Visual Analog Scale (VAS), and Profile of Mood States 2nd Edition (POMS2) Japanese Full Version) | — |
Secondary
| Measure | Time frame |
|---|---|
| Saliva volume, Saliva tests (salivary cortisol, salivary amylase, salivary chromogranin A), Pittsburgh Sleep Quality Index (PSQI), Oguri-Shirakawa-Azumi Sleep Inventory MA version (OSA-MA), Epworth Sleepiness Scale (ESS), Sleep Visual Analog Scale (VAS), State-Trait Anxiety Inventory (STAI), Patient Assessment of Constipation Quality of Life (PAC-QOL), Gut microbiota analysis, Fecal organic acid analysis, Fecal putrefactive product analysis | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed