A Confirmatory Study of the Immunomodulatory Function of Test Supplements in Healthy Adults - A Randomized, Double-Blind, Placebo-Controlled Comparative Trial
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000052736
- Lead Sponsor
- IMEQRD Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 100
Not provided
1.Currently receiving any medical treatment with drugs or Chinese herbs. Medications used as needed are acceptable. 2.Currently receiving any dietary treatment or exercise treatment under medical doctors. 3.Have malignancy or serious illnesses, or a history of serious illnesses in respiratory, digestive, endocrine, or metabolic organs. 4.Have been received resection of digestive organs, excluding cecum resection. 5.Have been used medical drugs which have immune modulatory effects, such as anti-allergy drugs and antibiotics, within one month before the screening visit. 6.Have been taking foods or dietary supplements with functional health claims that affect the outcome of the study. Who can discontinue intake during the study is acceptable. 7.Voluntarily consume yogurt or beverages containing lactic acid bacteria and bifidobacterial, over three times per week. Who can discontinue intake during the study is acceptable. 8.Have allergic rhinitis. 9.Have a history or current condition of asthma or atopic dermatitis. 10.Have allergies to drugs or foods. 11.Workers on night shifts or with irregular work schedules. 12.Have been vaccinated against influenza viruses or SARS-CoV-2 or infected with these viruses within 12 weeks before the screening visit, or are planning to be vaccinated during the study. 13.Heavy Smoker, over 21 cigarettes/day. 14.Alcohol drinkers, over 40 g/day of pure alcohol. 15.Are planning to make significant changes in lifestyle, such as eating habits, sleep duration, or exercise habits. 16.Are planning to travel abroad during the study period. 17.Currently pregnant or breastfeeding, or planning to become pregnant during the study. 18.Those who have participated in other clinical trials within one month before enrolling in the study, those who are currently participating in other clinical trials, and those who plan to participate in other clinical trials after enrolling in the study. 19.Who are unsuitable for the study, as determined by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method