Healthy adults
Conditions
Interventions
Consumption of the test food (1 bottle a day) for 4 weeks
Consumption of the placebo food (1 bottle a day) for 4 weeks
Sponsors
CPCC Company Limited
Meiji Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 20 to 59 years at the time of consent acquisition. 2. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail. 3. Subjects who feel a decline in their work performance.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of gastric or lower gastrointestinal surgery (excluding hemorrhoids and polypectomy). 2. Subjects scheduled to undergo gastric X-ray barium examination or small intestine/colon endoscopy at a clinic, or intestinal cleansing at a clinic or at home between the time of consent and the end of the trials. 3. Subjects planning to take or use medications that may affect the study (such as antibiotics, proton pump inhibitors (PPIs), diabetes medications (e.g., metformin), laxatives (e.g., magnesium oxide), or bile acid sequestrants (e.g., UDCA)) one or more times between the time of consent and the end of the trial. 4. Subjects scoring 50 or above on the Self-Rating Depression Scale (SDS). 5. Subjects with a history or current diagnosis of mental disorders, or those receiving treatment, medication, lifestyle guidance, or counseling for mental disorders. 6. Subjects who have smoking habit. 7. Subjects planning overseas travel, trips longer than one week, or business trips from one week before each intake period to the end of each intake period. 8. Subjects with allergies to food. 9. Females who are pregnant or lactating, and females who could become pregnant during trial period. 10. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Bacterial count of each gut microbiota species in feces - Occupancy rate of each gut microbiota species in feces - Salivary chromogranin A and oxytocin - Blood levels of zonulin, LBP, IL-6, TNF-alpha, high-sensitivity CRP, BDNF, L-DOPA, and 5-HTP - Questionnaires Performance-related indicators: WHO-HPQ (short form, Japanese version) Stress-related indicators: State-Trait Anxiety Inventory-Form JYZ (STAI), Brief Job Stress Questionnaire (57-item version), Chalder Fatigue Questionnaire Japanese version, Subjective Vitality Scale Japanese version (SVS-J) Well-being indicators: Cantril's Ladder, Japanese version of the Subjective Happiness Scale (SHS), Interdependent Happiness Scale (IHS) Sleep-related indicators: Pittsburgh Sleep Quality Index Japanese version (PSQI), Oguri-Shirakawa-Azumi Sleep Inventory MA version (OSA-MA) Gastrointestinal-related indicators: Izumo Scale | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed