Healthy adult male
Conditions
Interventions
Oral consumption of the test food (4 pieces per time, twice daily) for 4 weeks
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy males aged 30 to below 40 years at the time of consent acquisition. 2. Individuals with a body mass index (BMI) of 18.5 kg/m2 or higher and less than 25.0 kg/m2. 3. Individuals who constantly perceive daily stress. 4. Individuals who spend 30 minutes or more outdoors during the day (e.g., during commuting) without sunglasses. 5. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Exclusion criteria
Exclusion criteria: 1. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) that may affect the study (including sleep improvement and stress reduction claims) and are unable to discontinue use from one month before the pre-examination and test food intake. 2. Individuals who take medications (e.g., antibiotics, laxatives, gastrointestinal drugs) that may affect the study and who cannot restrict their use during the study period. 3. Individuals who are receiving medical care or drug treatment for a disease that may affect the study. 4. Individuals diagnosed with severe anemia based on pre-examination blood test results. 5. Individuals with a habit of consuming foods/beverages containing cacao, cocoa, or cocoa butter (once a week or more). 6. Individuals who dislike chocolate. 7. Individuals with bruises or scars on the skin measurement area (inner side of the left forearm). 8. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods. 9. Individuals with extremely irregular lifestyles (such as night shifts, irregular shift work, or irregular sleep habits). 10. Individuals with excessive alcohol intake. 11. Individuals who are in the habit of smoking, or have been in the habit of smoking within the past six months. 12. Individuals who, at the time of consent acquisition, have plans involving significant changes in lifestyle or sleep habits (e.g., overseas business trips of 2 weeks or longer) during the study period. 13. Individuals who will develop hay fever symptoms during the study period, or who plan to take medication during the same period. 14. Individuals with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs, etc., (including perioperative period).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Metabolomics | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily log (frequency of bowel movements, stool characteristics), Profile of mood states 2nd edition, VAS (Visual Analog Scale) questionnaire, Lifestyle questionnaire, PSQI (Pittsburgh Sleep Quality Index), SWLS (Satisfaction with Life Scale) (Japanese version), Hematological tests, Blood biochemical tests, Salivary cortisol, Salivary serotonin, Salivary oxytocin, Stratum corneum water content, Transepidermal water loss (TEWL), Skin viscoelasticity, Gut microbiota, Fecal short-chain fatty acids (SCFAs), Blood BDNF (Brain-derived neurotrophic factor) | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed