A Study on the Effect of Plant-Derived Products on Immune Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000046561
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 56
Not provided
Subjects(who) 1) contract, are under treatment for or have a history of serious diseases (e.g., diabetes, liver disease, kidney disease, heart disease, thyroid gland disease, adrenal gland disease and/or metabolic disease). 2) have a chronic disease and regularly use medications. 3) have a history and/or a surgical history of digestive disease affecting digestion and absorption. 4) are judged as unsuitable for the current study by blood tests in screening test. 5) have had no subjective symptoms of upper respiratory tract infection in the last two winters. 6) contract pollinosis or allergic rhinitis and use drugs. 7) can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting immune functions. 8) have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent. 9) are smokers 10) have a habit of strenuous exercise such as running or soccer. 11) can't stop drinking from a day before each measurement. 12) have declared allergic reaction to ingredients of test foods. 13) are under treatment for or have a history of drug addiction and/or alcoholism. 14) are shiftworker and/or midnight-shift worker. 15) are planning to go abroad, such as on an overseas trip. 16) are pregnant or breastfeed or planning to become pregnant. 17) have used drugs (including antiallergic drugs and antibiotics) that are thought to affect immune function within two weeks prior to the screening test. 18) have donated over 200 mL of blood and/or blood components within the last four weeks prior to the screening test or over 400 mL of blood and/or blood components within the last three months prior to the screening test. 19) are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. 20) are judged as unsuitable for the current study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major immune marker
- Secondary Outcome Measures
Name Time Method Other immune marker Physical condition questionnaire