A verification test of inhibition effect for acute upper respiratory tract inflammation by consumption of test food
- Conditions
- Acute upper respiratory tract inflammation
- Registration Number
- JPRN-UMIN000038168
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 72
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method *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 Outcome Measures
Name Time Method *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)