A study for evaluating the effect of the intake of a lactic acid bacterium -containing food on salivary secretory immunoglobulin A (sIgA) and fatigue : a randomized, double blind, placebo-controlled, parallel-group trial
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000022880
- Lead Sponsor
- TTC Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
1) Subjects that regularly consume food rich in lactic acid bacteria more than 3 times a week 2) Subjects with regular consumption of lactic acid bacteria -fortified food or lactic acid bacteria preparation 3) Subjects that regularly consume dietary supplements which may influence immune function 4) Subjects with history of the allergic disease 5) Subjects undergoing medical treatment which may influence the outcome of the study (e.g., hyposensitization) 6) Subjects who have received oral or dental treatment from one month before the screening tests or intend to receive oral or dental care during the study 7) Subjects with oral or dental problems (e.g., stomatitis, oral mucosal bleeding) or develop them more than once a week 8) Subjects with regular bleeding gums during brushing 9) Night and day shift worker or manual laborer 10) Subjects with intensive physical activity (e.g., marathon race) 11) Subjects with poor adherence to the measurement procedures 12) Subjects undergoing medical treatment or require medical treatment 13) Subjects with severe diseases (e.g., diabetes, liver disease, kidney disease, or heart disease) and diseases that may affect the adrenal cortical hormone secretion 14) Subjects potentially allergic to contents in test food such as lactic acid bacteria 15) Subjects who are judged inappropriate for the study according to the results of screening tests 16) Subjects who intend to become pregnant during the study period or being pregnant or lactating 17) Subjects who have participated in other clinical studies within one month from obtaining informed consent or intend to participate in other clinical studies after obtaining informed consent 18) Subjects who are judged inappropriate for the study according to the results of lifestyle questionnaire 19) Subjects who are judged inappropriate for the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method salivary sIgA secretion rate
- Secondary Outcome Measures
Name Time Method salivary sIgA concentration, POMS2