Male/female adults
Conditions
Interventions
Oral consumption of the test food, three times daily for 12 weeks.
Oral consumption of the placebo food, three times daily for 12 weeks.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy men and women aged 20 to below 60 years at the time of consent acquisition. 2. Subjects who perceive themselves as being prone to catching colds. 3. Subjects 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. Subjects who regularly consume Foods for Specified Health Uses (FOSHU), foods with functional claims, or health foods (including supplements) that claim to support immune function three or more times per week. 2. Subjects who cannot discontinue the consumption of Foods for Specified Health Uses (FOSHU), foods with functional claims, or health foods (including supplements) that claim to support immune function from the time of consent. 3. Subjects taking medications that may affect the trial (such as antibiotics, probiotics, or laxatives) and are unable to restrict use during the trial period. 4. Subjects who received a vaccine, such as the influenza or coronavirus vaccine, within six months prior to providing consent. 5. Subjects planning to receive the influenza or coronavirus vaccine after providing consent. 6. Subjects 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. 7. Subjects with a habit of consuming 2 liters or more of tea beverages per day. 8. Subjects with excessive alcohol intake. 9. Subjects with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs. 10. Females who are pregnant or lactating, and those who intend to become pregnant during the trial period. 11. Subjects with allergies to medications and/or food, especially tea. 12. Subjects who plan to take medication for seasonal allergies during the trial period (excluding temporary use of eye drops or nasal sprays). 13. Subjects who donated 200 mL of their blood or blood components within the last month. 14. Subjects who donated 400 mL of his blood within the last 3 months. 15. Subjects who donated 400 mL of her blood within the last 4 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of upper respiratory tract symptoms during the study period, based on the daily diary. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in plasmacytoid dendritic cell (pDC) activity - Number of occurrences of upper respiratory tract symptoms during the trial, based on the daily diary. - Duration of illness per occurrence of upper respiratory tract symptoms, based on the daily diary. - Number of days from the start of the trial until the onset of upper respiratory tract symptoms, based on the daily diary. - Salivary sIgA concentration and salivary sIgA secretion rate - Severity score of 10 upper respiratory tract symptoms using the Japanese version of the WURSS-21 questionnaire. - Total severity score of 10 upper respiratory tract symptoms using the Japanese version of the WURSS-21 questionnaire. - Level of interference with health-related quality of life (9 items) using the Japanese version of the WURSS-21 questionnaire - Total level of interference with health-related quality of life (9 items) using the Japanese version of the WURSS-21 questionnaire - Incidence rate of adverse events and side effects | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed