Effects of test food intake on immune indicators and subjective symptoms related to physical condition changes in healthy individuals. -A randomized, placebo-controlled, double-blind, parallel-group comparison study
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000053429
- Lead Sponsor
- KSO Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 140
Not provided
Subjects(who) 1. have serious illnesses such as diabetes, kidney and liver diseases, heart diseases, thyroid diseases, adrenal diseases, other metabolic diseases, those who are undergoing treatment, and those with a medical history. 2. have a chronic disease and regularly use medications. 3. with hay fever, atopic dermatitis, bronchial asthma, and chronic bronchitis. 4. contract or have a surgical history of digestive disease affecting digestion and absorption. 5. have been diagnosed as dry mouth. 6. have dental or oral problems accompanied by bleeding (such as canker sores). 7. have received dental treatment or dental checkups within 24 hours prior to the screening test date, or willing to receive dental treatment or dental checkups within 24 hours prior to each examination. 8)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting immune functions 9. are unable to stop taking supplements and health foods (including functional foods) that may affect their immunity. 10. have an excessive drinking habit of more than approximately 60 grams of pure alcohol per day and who consume more than 20 grams of alcohol per day during the study period. 11. are unable to abstain from alcohol for 2 days before each examination, including the screening test. 12. have declared allergic reaction to ingredients of test foods. 13. smoke 21 or more cigarettes a day. 14. are under treatment for or have a history of drug addiction and/or alcoholism. 15. are shift worker and/or midnight-shift worker. 16. to 22. are listed in the "Other related information" column.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major immune markers
- Secondary Outcome Measures
Name Time Method questionnaire (Physical condition, QOL) Other immune markers