Male/female adults
Conditions
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy men and women aged 40 to below 60 years at the time of consent acquisition. 2. Subjects with a Body Mass Index (BMI) less than 25.0 kg/m2. 3. Non-smokers (no smoking in the past year). 4. 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 are continuously taking prescription medications and cannot discontinue their use during the trial period. 2. Subjects who consume Food for Specified Health Uses (FOSHU), Foods with Function Claims (e.g., GABA, Lactobacillus gasseri CP2305), or health food (including supplements) affecting the autonomic nervous system, stress, fatigue, and brain function at least once a week. 3. Subjects who cannot discontinue the consumption of Food for Specified Health Uses (FOSHU), Foods with Function Claims (e.g., GABA, Lactobacillus gasseri CP2305), or health food (including supplements) affecting the autonomic nervous system, stress, fatigue, and brain function during the trial period. 4. 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. 5. Subjects who have experienced significant life changes such as moving, changing jobs, or separation from close relatives within the last three months prior to consent acquisition, which could lead to high stress, or those likely to experience such events during the study period. 6. Subjects with extremely irregular eating habits or work schedules, including shift workers and night workers, who have irregular life rhythms. 7. Subjects who engage in excessive physical exercise routinely. 8. Subjects with excessive alcohol intake. 9. Subjects who find it difficult to abstain from alcohol from the day before the trial begins. 10. Subjects unsuitable for heart rate measurement due to issues such as dense chest hair, use of a pacemaker, or skin sensitivity on the chest area. 11. Subjects with severe symptoms of Premenstrual Syndrome (PMS). 12. Subjects with allergic rhinitis that may interfere with trial operations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitrax (Symbol Digit Coding (SDC) Test, Stroop Test, Attention Shift Test) | — |
Secondary
| Measure | Time frame |
|---|---|
| Profile of Mood States 2 (POMS2) Japanese short version, Psychological questionnaire, Heart rate | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed