None listed
Conditions
Interventions
Dietary Supplement : The product name of the test food is Coleopterose-PBS, and the raw material is a hot water extract derived from Protaetia brevitarsis seulensis. The surface component is an acidic
Sponsors
Semyung University Oriental Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 19 to 70 years old 2. Those with white blood cells greater than 4.0×103 cells/µl and less than 8.0×103 cells/µl 3. Those who have had symptoms of upper respiratory tract infections (cold, tonsillitis, pharyngitis, laryngitis, sinusitis, otitis, rhinitis, etc.) at least twice within the past year as of the screening date 4. A person who voluntarily agrees in writing to participate in this human body application test
Exclusion criteria
Exclusion criteria: 1. A person who is allergic to white-spotted flower radish larvae or has a history of hypersensitivity reactions and side effects to medicines, food ingredients, herbal extracts, herbal medicine, etc. 2. Platelet 100 × 103/µL or less 3. A person who has donated whole blood within two months at the time of screening or who has donated ingredients within four weeks 4. A person with a body mass index of less than 18.5 kg/m2 or more than 30.0 kg/m2 5. A person who has taken immunostrengthening agents or immune-related health functional foods within the past four weeks at the time of screening 6. A person who has been vaccinated against influenza within the past three months at the time of screening 7. A person who has taken drugs that affect the absorption, metabolism, and excretion of test foods, such as herbal medicine, immunosuppressants, nonsteroidal anti-inflammatory drugs, steroid drugs, antihistamines, antibiotics, hormones, etc. within the past four weeks at the time of screening; 8. A person with immune-related diseases such as liver disease, leukemia, inflammatory systemic disease, infectious disease, autoimmune disease, etc., including active hepatitis 9. A person who is being treated for clinically significant acute or chronic cardio-cerebrovascular relationships, immune system, respiratory system, biliary system, kidney and urinary system, nervous system, musculoskeletal disease, mental, infectious and hematologic/tumor cancer disease, etc. (However, participation in the study may be made at the discretion of the person in charge of testing considering the condition of the subject.) 10. A person who has performed surgery such as gastrointestinal dysfunction or gastrectomy, such as gastrointestinal disease (Cron's disease, etc.), irritable bowel syndrome, etc 11. A person with endocrine disease (metabolic syndrome) or thyroid disease (hyperthyroid or hormonal abnormalities/hyperthyroid hormone levels) 12. Those with uncontrolled hypertension (systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg) 13. Those with renal disease or severe renal dysfunction (eGFR<60 ml/min/1.73m2) 14. A person whose AST and ALT exceed three times the upper limit of the agency's normal limit 15. Patients with uncontrolled diabetes (with fasting blood glucose greater than 126 mg/dL or within 3 months of the screening visit) who have initiated new medication or had a dose change due to diabetes 16. A person who has severe mental illness such as depression, schizophrenia, anxiety disorder, etc., or has a history of treatment for alcoholism or substance abuse 17. People with alcohol intake of 280 g/week for men and 140 g/week for women or more 18. Pregnant women, lactating women, or women of childbearing age who do not use appropriate contraceptive methods (or oral contraceptives, hormonal transplants, intrauterine appliances, condoms, and fertilizers) 19. A person who has participated in another clinical or human application trial within the last three months at the time of screening 20. a person who has undergone surgical procedures within the last six months 21. A person who is deemed unable to comply with the test or is not eligible to participate in this human body application test at the judgment of the Tester
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in NK cell activity (50:1, 25:1, 12.5:1);Change in NK cell count (%);Change in Cytokine (TNF-a, IFN-?, IL-4, IL-10, IL-12) | — |
Secondary
| Measure | Time frame |
|---|---|
| Dietary surveys(24 hour recall method);Survey of lifestyle(smoking, drinking, caffeine intake);Survey of International Physical Activity Survey (GPAQ);Adverse Event;Vital signs (blood pressure, pulse, body temperature);Body Measurement (Weight, BMI);Diagnostic laboratory medical examination (hematologic examination, blood biochemical examination, urine examination) | — |
Countries
Korea, Republic of
Contacts
Public ContactSeon Gyu Bae
Semyung University Oriental Medicine Hospital
Outcome results
None listed