A Study on the Effect of Plant-Derived Products on Mucosal Immune Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000042653
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
Subjects (who) (1)have never had an upper respiratory tract infection or viral gastroenteritis in the last two winters. (2)have a faster salivary sIgA secretion rate. (3)contract diseases (e.g., diabetes, liver disease, kidney disease, heart disease, respiratory disease, endocrine disease and/or metabolic disease). (4)have a chronic disease and regularly use medications. (5)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting immune functions. (6)can't stop taking foods containing lactic acid bacteria, bifidobacteria, oligosaccharides, and/or live bacteria during test periods. (7)regularly eat foods containing lactic acid bacteria, bifidobacteria, and/or oligosaccharides. (8)get intense exercises (e.g., muscle training in the gym) more than 3 times a week. (9)are under treatment for periodontal disease. (10)used antibiotics within the last two weeks prior to the screening. (11)can't stop drinking from 2 days before each measurement. (12)have declared allergic reaction to ingredients of test foods. (13)have a history of and/or contract pollinosis and/or allergic rhinitis. (14)have a history and/or a surgical history of digestive disease affecting digestion and absorption. (15)plan to become pregnant after informed consent, pregnant or lactating. (16)are judged unsuitable for the study by the screening. (17)have donated over 200 mL of blood and/or blood components within the last one month or over 400 mL of blood and/or blood components within the last 3 months prior to the study. (18)are under treatment for or have a history of drug addiction and/or alcoholism. (19)are shiftworker, midnight-shift worker and/or teleworker. (20)are planning to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month prior to the study. (21)are judged unsuitable for the study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method salivary sIgA
- Secondary Outcome Measures
Name Time Method Incidence of symptoms of the common cold