Healthy adult
Conditions
Interventions
Intake 180 mL of test food a day divided 3 times (60mL each) four consecutive weeks.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Male and female aged over 20 years old when consent acquisition. (2)Subjects who can intake test food every day. (3)Subjects who notice themselves as they are perennial allergic rhinitis. (4)Subjects giving written informed consent.
Exclusion criteria
Exclusion criteria: (1) Subjects who have treated or taken medicine for perennial allergic rhinitis from 4 weeks short the end of the study. (2) Subjects who planning some treatment during the examination period. (3) Subjects who having Food for Specified Health Uses (FOSHU) and/or health food. (4) Pregnant or expected pregnant, and lactating women. (5) Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney. (6) Subjects who excessive alcohol intake. (7) Subjects who have smoking habit. (8) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. (9) Subjects who have previous medical history of drug and/or food, allergy, especially for Shiso leaf. (10) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (11) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (12) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study. (13) Females who donated over 400mL blood and/or blood components within the last four month to the current study. (14) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (15) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (16) Others who have been determined ineligible by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NK cells activity | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: nonspecific IgE, allergen-specific IgE (for 8 allergens), IgD, IgG, IgM, Japan Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ). Safety evaluation items: physiological examination, hematological examination, blood biochemical examination, urine examination, presence or absence of, type of, severity of and frequency of side effects and adverse events | — |
Countries
Japan
Contacts
Public ContactSuguru Fujiwara
CPCC Co., Ltd. Clinical Research Planning Department
Outcome results
None listed