Male/female adults
Conditions
Interventions
None listed
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Males and females aged more than or equal to 20, and less than 80 when obtaining the consent. (2)Non-smokers for more than 1 year. (3)Subjects with a BMI of not less than 18.5 kg/m^2, but less than 35.0 kg/m^2. (4)Subjects who can comply with the dietary and behavioral restrictions on the day before and the day of the test. (5)Subjects who can understand the study protocol and agree to participate in the study, by written informed consent prior to the study.
Exclusion criteria
Exclusion criteria: (1)Subjects who are regularly consuming food for specified health uses (FOSHU), food with function claims, supplement and/or health foods which would affect the study results for more than 3 days a week. (2)Subjects who have a plan or who have taken medication (e.g., antibiotics, steroids, antihistamines), which would affects the study results. (3)Subjects who take excessive alcohol. (4)Subjects who are participating or have participated in another clinical study with medicine/food within the last 4 weeks before this study, or are planning to join those after giving informed consent. (5)Subjects who will be vaccinated with various vaccines during the month leading up to the test-1 and during the test period (e.g., those who are waiting for an appointment or standby for coronavirus vaccination). (6)Subjects who have current medical history/anamnesis of severe cardiac, hepatic, renal or digestive diseases. (7)Subjects who are pregnant, lactating, or intend to become pregnant during the study period. (8)Subjects who are allergic to drugs or foods. (9-11)Subjects who have been donated their blood components and/or whole blood prior to the pre-inspection as follows: - males/females: 200 mL of blood components within a month - males: 400 mL of whole blood within the last 3 months - females: 400 mL of whole blood within the last 4 months. (12-13)Subjects who have been donated their blood within the last 12 months, which would reaches to the following volume after adding their blood amount planning to be collected in this study; - males: 1,200 mL - females: 800 mL (14)Subjects with systolic blood pressure of 180 mmHg or higher, and/or diastolic blood pressure of 110 mmHg or higher. (15) Others who have been determined ineligible by principal/sub investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune cell analysis: expression analysis of cell surface marker in PBMC | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody testing of saliva and serum: antibodies specific to various antigens (microbes and allergens) | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed