The Evaluation of the Efficacy and Safety of NAO on Immune functio
- Conditions
- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0006925
- Lead Sponsor
- Dynebio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1) Male and female subjects aged between 20 years and 75 years
2) Those with a peripheral blood leukocyte count of 3X103 cells/µL or higher and 8X103 cells/µL or lower measured at Visit 1
3) Stress self-assessment scaled above strong
4) Those who have had upper respiratory tract infections twice or more within 1 year based on visit 1 {*tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, etc}
5) Those who agree to participate in this study before the study and fill out the Informed Consent Form
1) Subjects who have past history or are currently in the treatment of significant clinical disease related to the acute or chronic cardiovascular system, immune system, respiratory system, liver biliary, kidney and urinary tract, nervous system, musculoskeletal disorders, psychic, infection, and blood neoplastic. (However, subjects are possible to participate in the study at the discretion of the study director)
2) Subjects who have uncontrolled high blood pressure. (Higher than 160/100mmHg, measured 10 minutes after stabilizing)
3) diabetes patients (fasting glucose level that is more than normal of this organization or had been taking or currently are taking a drug due to diabetes in the past
4) Subjects whose AST (GOT) or ALT (GPT) is higher than 3 times of normal upper limit in the blood
5) Subjects whose creatinine exceeds 1.5 times of normal upper limit in the blood
6) Subjects who got a vaccination within 3 months before screening.
7) Subjects who got a COVID-19 vaccination within 6 weeks before screening.
8) Subjects who have used steroids within 4 weeks before screening.
9) Subjects who have used immunosuppressants, gastric acid inhibitors, or statins within 2 weeks before screening.
10) Subjects who have used antibiotics within 2 weeks before screening.
11) Subjects who have consumed probiotics or lactobacillus products continuously (more than 4 times a week) within 2 weeks before screening.
12) Subjects who had intaken or is intaking functional foods that have the potential of affecting the immune system within 2 weeks s before the screening.
13) Subjects who have complained of severe gastrointestinal symptoms such as heartburn, indigestion.
14) Subjects who are planning a pregnancy, breastfeeding during this study.
15) Subjects who have participated in other interventional studies within 1 month before the screening, or who plan to participate in other interventional studies after the start of this study.
16) Subjects who are sensitive to foods or have food allergies.
17) Body Mass Index (BMI) of 30 kg/m2 or more
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method atural Killer(NK) cell activity
- Secondary Outcome Measures
Name Time Method Cytokine (TNF-a, IFN-?, IL-4, IL-10, IL-12);WBC Count;Self evaluation of the improvement on immune function;Adverse event