A study to evaluate the effect of food ingredient in healthy adult on the immune system -Placebo-controlled, randomized, double-blind, parallel-group comparative method
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000045838
- Lead Sponsor
- CPCC Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
Not provided
(1) Subjects who regularly intake food containing involvement ingredients at least 3 times a week. (2) Subjects who constantly use supplements or drugs affecting the immune system. (3) Subjects who regularly intake food or medicines rich in lactic acid bacteria at least 3 times a week (4) Subjects who undergoing treatment affecting the outcome of the study (5) Night and day shift worker or manual laborer (6) Subjects who are habitually vigorous exercise such as marathon (7) Subjects who cannot carry out the inspection procedure of various inspection by the rule during the study period (8) Subjects are undergoing medical treatment or judged as require medical treatment (9) Subjects who have under treatment or a history of serious disease (10) Subjects who are pregnant, lactating, or intending to become pregnant during the study period (11) Subjects who are allergic to medicines and foods (12) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (13) Subjects who are participating in other clinical trials of drug or health food, or within 4 weeks of completion of the trial, or who plan to participate in other clinical trials after agreeing to participate in the study (14) Subjects who have donated 200 mL component blood or whole blood for 1 month prior to the study (15) Men who have donated 400 mL whole blood for 3 months prior to the study (16) Women who have donated 400 mL of whole blood for 4 months prior to the study (17) Men who have donated more than 1,200 mL of blood in the 12 months prior to the study, by adding the total planned blood collection volume for the study (18) Women who have donated more than 800 mL of whole blood in the 12 months prior to the study, by adding the total planned blood volume for the study. (19) Subjects who are judged as unsuitable for the study by the principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immune function
- Secondary Outcome Measures
Name Time Method Physical condition questionnaire