Acute upper respiratory tract inflammation
Conditions
Interventions
One test food is extracted by 150mL of hot water. Intake the test food extract 3 times a day for 12 weeks.
One control food is extracted by 150mL of hot water. Intake the control food extract 3 times
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Males and Females aged 20 to 59 years old when informed consent. (2) Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent.
Exclusion criteria
Exclusion criteria: (1)Subjects who have infected influenza between 8 months ago from informed consent and 24 hours before test start. (2) Subjects who have injected influenza vaccine within 8 months from informed consent. (3) Subjects who ingesting Food for Specified Health Use (FOSHU), functional indication food and health food on a daily bases. And subjects who will not quit ingesting them during test period. (4) Subjects who have allergy to tea, such as green tea, oolong tea, black tea and/or barley tea. (5) Subjects who have custom of drinking tea more than 2L a day. (6) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). (7) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. (8) 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. (9) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (10) Males who donated over 400mL blood and/or blood components within the last three month to the current study. (11) Females who donated over 400mL blood and/or blood components within the last four month to the current study. (12) 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. (13) 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. (14) Others who have been determined ineligible by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Incidence of upper respiratory tract inflammation during test period *Incidence of influenza infection during test period *Number of onset of upper respiratory tract inflammation during test period *Duration of each upper respiratory tract inflammation during test period *Days from the start of the study to the onset of upper respiratory tract inflammation and influenza | — |
Secondary
| Measure | Time frame |
|---|---|
| *Change of sIgA concentration in salivary *Change of NK-cell activity *WURSS-21 Japanese version *Incidence of adverse event and side effect *Body weight *BMI *Physiological tests *Hematological tests *Blood biochemical tests *Urine tests *Feces tests (short chain fatty acid, intestinal microbiota) | — |
Countries
Japan
Contacts
Public ContactYuko Tanaka
Mitsui Norin Co., Ltd. Fundamental development team, R&D group
Outcome results
None listed