KCT0002551
Recruiting
未知
A 8 week, randomized, double-blind, placebo-controlled clinical trial of APGP for the evaluation of efficacy on immune function and immune cell activation
ConditionsNot Applicable
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not Applicable
- Sponsor
- Yonsei University
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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