Healthy adults (Male/female)
Conditions
Interventions
Oral consumption of the test food (1 bottle, once daily) for 12 weeks
Oral consumption of the placebo food (1 bottle, once daily) for 12 weeks
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese men and women aged 20 to below 65 years at the time of consent acquisition. 2. Participants who are aware of that they are prone to catching colds. 3. Participants who are able to agree to participate in this study with a written document after receiving a detailed explanation of the protocol and understanding its contents.
Exclusion criteria
Exclusion criteria: 1. Participants who regularly consume Foods for Specified Health Uses (FOSHU), Foods with Functional Claims, or health foods (including supplements) three or more times per week. 2. Participants who are unable to discontinue the consumption of Foods for Specified Health Uses (FOSHU), Foods with Functional Claims, or health foods (including supplements) from the time of consent acquisition. 3. Participants taking medications (such as antibiotics, intestinal regulators, laxatives, etc.) that are considered to potentially affect the study and are unable to restrict their use during the study period. 4. Participants 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. 5. Participants with excessive alcohol intake. 6. Participants who are unable to discontinue the consumption of foods containing a large amount of lactic acid bacteria or bifidobacteria (such as yogurt, lactic acid drinks, fermented pickles including kimchi and nukazuke made with lactic acid bacteria, but excluding unfermented pickles like salt-pickled vegetables) from the time of consent acquisition until the end of the study. 7. Participants who are aware of having hay fever, regularly taking or using medications for hay fever every year (excluding eye drops), or planning to use such medications during the study period. 8. Night shift workers. 9. Heavy smokers (21 or more cigarettes per day). 10. Participants planning to receive vaccinations (for influenza, COVID-19, etc.) from the time of consent acquisition until the end of the study. 11. Participants planning to travel overseas between the time of consent acquisition and the end of the study. 12. Participants with chronic diseases such as diabetes, hypertension, or dyslipidemia, who are regularly taking medications. 13 Participants who are prone to diarrhea after consuming dairy products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative number of days with reported symptoms during the consumption period, based on the self-reported physical condition questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| pDC activity (fluorescence intensity of CD86, HLA-DR, CD40, CD80), proportion of positive cells (pDCs as a percentage of monocytes, percentage of CD86+, HLA-DR+, CD40+, CD80+ among pDCs), IFN-alpha levels. | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed