Healthy male/female adults
Conditions
Interventions
Oral ingestion of the test food with water/lukewarm to the subjects at breakfast, 1 drop a day.
Oral ingestion of the placebo food with water/lukewarm to the subjects at breakfast, 1 drop a day.
Sponsors
CPCC Company Limited
Macromill, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male/female subjects ranging in age from 20 to 69 at informed consent. (2) Subjects with no smoking (not less than one year). (3) Subjects having not less than 18.5 kg/m2, but less than 30.0 kg/m2 of BMI. (4) Subjects who can observe the rules (meals and behaviors) on the previous/appointed test days. (5) Subjects who can give informed consent to participate in this research, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: Subjects - - (1) who take steadily (not less than 3 times a week) in the health-specific/functional/supplementary/health foods (e.g., immune function). (2) with excessive alcohol intake. (3) who will be under a large variable condition, such as house-moving, transfer, diet. (4) with extremely irregular eating habits / life rhythm (irregular shift work or midnight one). (5) with history of tonsil/appendix removal. (6) who have received affecting surgeries (colonoscopy, gallstones/gall bladder removal, gastric bypass) within half a year before the consent. (7) with any difficulty in giving up taking medicines (e.g., antibiotics, steroids, antihistamines) during this research. (8) who have taken antibiotics within the last month before beginning the research-food intakes, or will take those. (9) having continuous allergy, and will take medicine. (10) undergoing dental treatment for gingivitis/periodontitis, or bleeding daily in the mouth. (11) with heavy exercises, not less than 4 days a week. (12) being under other clinical researches, or participated in those within the last four weeks before this research, or will join those after the consent. (13) will vaccinate within the designated periods. (14) whose roomer/acquaintance will take part in this research. (15) with medical history of serious diseases in heart, liver, kidney or digestive organs. (16) with pregnant, possibly pregnant, or lactating. (17) having drug/food allergy. (18) donated their blood components and/or whole blood (0.2 L) within a month to this research. (19) donated his whole blood (0.4 L) within the last 3 months to this research. (20) donated her whole blood (0.4 L) within the last 4 months to this research. (21) being collected in total of his blood (1.2 L) within the last 12 months and in this research. (22) being collected in total of her blood (0.8 L) within the last 12 months and in this research. (23) determined as ineligible for participation, by the principal/sub investigator - -.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The analysis of the immune cell | — |
Secondary
| Measure | Time frame |
|---|---|
| The antibody test of the saliva | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed