APGP for the evaluation of efficacy on immune function and immune cell activatio
- Conditions
- Not Applicable
- Registration Number
- KCT0002551
- Lead Sponsor
- Yonsei University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1) Male or female subjects aged from 25 to 75 years old
2) Screening white blood cell(WBC) ranged from 4X103to 8X103cells/ul
3) Stress self assessment scaled above "strong"(4 scales: none, moderate, strong, intense)
4) Subjects who agreed to participate in this study and signed written informed consent voluntarily
1) Subjects who are currently in the treatment of significant clinical disease related to 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 by the discretion of the study director)
2) Subjects who have uncontrolled high blood pressure. (Higher than 140/90mmHg, measured 10 minutes after stabilizing)
3) Patients with uncontrolled diabetes. (126mg/dl or higher fasting glucose, or beginning of a new drug within 3months due to diabetes)
4) Subjects who got a vaccination within 3months before the screening.
5) Subjects whose ALT (GOT) or AST (GPT) exceeds two times the upper limit of normal levels (ULN)
6) Subjects whose blood creatinine level exceeds 1.5 times upper limit of normal levels (ULN)
7) Subjects who have taken or is taking functional foods that have the potential of affecting the immune system.
8) Subjects who have complained of severe gastrointestinal symptoms such as heartburn, indigestion.
9) Subjects who are planning a pregnancy, breastfeeding during this study.
10) Subjects who are sensitive to foods or have food allergies.
11) Subjects who are planning to participate other studies during this study.
12) Subjects who were involved in other human applied studies within 4weeks of this study begins.
13) Subjects who are deemed to be inappropriate to this human applied study.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method K cell activity (25:1, 50:1, 100:1);Number of White Blood Cell (WBC);Interferon gamma (IFN-?);Interleukin-6 (IL-6), Interleukin-12 (IL-12);Tumor necrosis factor-a (TNF-a);Immunoglobulin G1 (IgG1), Immunoglobulin G2 (IgG2);The participant's self-evaluation regarding his health improvement
- Secondary Outcome Measures
Name Time Method hematologic examination