Effect of Daily Ingestion of Test Food on Immune Function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000048355
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 100
Not provided
1. Subjects who are under physician's advice, treatment, and/or medication for autoimmune diseases, chronic inflammatory diseases or allergic disease. 2. Subjects who take antihypertensive agents, immunosuppressive drugs, and/or indomethacin. 3. Subjects who have been vaccinated within the last 4 weeks prior to the screening test. 4. Subjects who plan to get vaccinated between 4 weeks prior to the start and end of ingestion of test food, at the time of screening test. 5. Subjects with implantable electronic medical devices. 6. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 7. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 8. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 9. Subjects with severe anemia. 10. Pre- or post-menopausal women complaining of obvious physical changes. 11. Subjects who are at risk of having allergic reactions to drugs and/or foods. 12. Subjects who regularly take medicine, functional foods, and/or supplements which would affect immune function. 13. Subjects who regularly take barley. 14. Heavy smokers, alcohol addicts and/or subjects with disordered lifestyle. 15. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study. 16. Pregnant or lactating women or women who expect to be pregnant during this study. 17. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 18. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Physical Condition Questionnaire
- Secondary Outcome Measures
Name Time Method K cell activity, peripheral blood pDC activity, serum cytokines (IFN-alfa, IFN-gamma, IL-12), salivary secretory IgA