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. Office workers or part-time employees who work indoors at least once a week. 3. Subjects who have a self-awareness of being prone to catching colds. 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 test positive for any one of the following in the preliminary examination: HBs antigen, HCV antibodies, syphilis antibodies, HIV antigens or antibodies. 2. Subjects who plan to receive any type of vaccine between the time of consent acquisition and the end of the study, excluding vaccination in this study. 3. Subjects with chronic conditions such as chronic rhinitis or asthma, which could be difficult to distinguish from upper respiratory tract infections. 4. Subjects with severe hay fever who cannot restrict medication during the trial period (excluding eye drops and nasal sprays). 5. Subjects who experience abdominal symptoms (such as diarrhea, abdominal pain, bloating) upon consumption of dairy products. 6. Subjects who regularly use Food for Specified Health Uses (FOSHU), Foods with Function Claims, or health food (including supplements) more than twice a week, which may potentially affect the study and cannot discontinue them from the time of consent acquisition. 7. Subjects who are taking medications (such as antibiotics, Intestinal preparations, laxatives) more than twice a week, which may potentially affect the trial, and cannot restrict their use during the study period. 8. Subjects who excessive alcohol intake. 9. Subjects who smoke heavily (not less than 21 cigarettes a day) 10. Subjects with having irregular life rhythms, such as extremely irregular eating habits or those working night shifts. 11. Subjects with an exercise routine of more than five times per week, each session lasting more than 30 minutes. *For reference, exercise is defined as activities corresponding to 7 METs or higher according to the METs table published by the Ministry of Health, Labour and Welfare.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaccine antibody titer against influenza virus | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of seroprotected subjects (anti-Flu antibody titer of 40 or higher) Immunity index of peripheral blood Immunity index of saliva and nasal mucosa Severity of cold-like symptoms Fecal microbial omics analysis Questionnaire on physical condition | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed