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-UMIN000045840
- Lead Sponsor
- KSO Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
Not provided
(1)Subjects who regularly intake food containing involvement ingredients at least 3 times a week (2)Subjects suffering from, undergoing treatment for, or with a history of serious diseases (3)Subjects who have chronic diseases and take medication on a daily basis (4)Subjects who regularly use medicines, food for specified health use or functional food, or health food that may affect immunity (5)Subjects who have a habit of taking lactobacillus-rich foods or lactobacillus preparations at least three times a week (6)Subjects who consistently drink more than the appropriate amount of alcohol (7)Subjects who are unable to abstain from alcohol for 2 days prior to screening test and each test (8)Subjects who have food allergies (9)Subjects who are undergoing treatments that may affect the research results (10)Subjects who work day and night shifts or engage in physical labor such as carrying heavy loads (11)Subjects who habitually engage in intense physical activities such as marathon (12)Subjects who fail to follow the prescribed procedures for the various tests during the study (13)Subjects with digestive diseases affecting digestion and absorption and Subjects with a history of digestive surgery (14)Pregnant women, women who intend to become pregnant during the research period, and women who are breastfeeding (15)Subjects who are judged to be inappropriate as research subjects based on blood tests (16)Subjects who have a history or current condition of drug or alcohol dependence (17)Subjects who are participating in research involving the ingestion of other foods or the use of other medicines (18)Subjects who plan to travel abroad, including overseas travel, during the study (19)Subjects who has donated more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of obtaining consent, or donated blood components (20)Subjects who judges to be inappropriate as research subjects 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