None listed
Conditions
Interventions
Dietary Supplement : Eat test food (KBH-HM01) or placebo twice daily, once a sachet for 12 weeks.
Sponsors
KolmarBNH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women aged 19 or older and 70 or younger 2) Those whose peripheral blood leukocyte levels measured in visits 1 and 2 are greater than 4x10³ cells/µL and less than 8x10³ cells/µL 3) A person who meets at least one of the following criteria ? A person who has had at least two upper respiratory tract infections* within one year based on visit 1 *{Common cold, acute tonsillitis, acute pharyngitis, acute laryngitis, acute rhinitis, etc.} ? A person who has had stomatitis at least once within one year as of visit 1 ? A person who has been infected with Herpes Zoster at least once within one year as of visit 1 ? A person who has had at least one uncomplicated cystitis within one year of visit 1 4) A person who has agreed to participate in this human body application test before the commencement of the human body application test and has completed a written consent form
Exclusion criteria
Exclusion criteria: 1) Those currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary system, kidney and urinary system, nervous system, psychiatric, infectious disease, and malignant tumors (but may participate in the test at the discretion of the examiner considering the condition of the subject of the human body application test) 2) A person currently undergoing treatment for an upper respiratory tract infection 3) Persons with diseases that may affect the immune response, such as adult asthma, rhinitis, allergies, etc 4) A person who has been inoculated with a vaccine (influenza, COVID-19 virus, shingles, etc. that may affect immunity) within three months as of visit 1 5) A person who has undergone surgery within 6 months based on visit 1 6) Those who develop symptoms of COVID-19 virus infection and patients within 3 months based on visit 1 7) A person who has administered systemic steroid drugs, nonsteroidal anti-inflammatory drugs, antihistamines, antibiotics, and immunosuppressants within one month of visit 1 8) A person who has taken health functional foods and vitamins that may affect immunity within two weeks of visiting 1 9) Those with a body mass index (BMI) of 30 kg/m² or higher 10) Those who consumed too much alcohol within one month (30 days) based on Visit 1 (men>210 g/week, women>140 g/week) 11) A person complaining of severe gastrointestinal symptoms such as heartburn and indigestion 12) Hypertension patients (systolic blood pressure 140 mmHg or more or diastolic blood pressure 90 mmHg or more, and measurement criteria after stabilizing for 10 minutes for human body application test subjects) 13) Diabetes patients with fasting blood sugar of 126 mg/dL or more or who are on antidiabetic medications (such as oral hypoglycemic agents, insulin, etc.) 14) Those with a CRP of 0.5 mg/dL or more as measured in Visits 1 and 2 15) Those with a TSH of 0.1 µIU/mL or less or 10 µIU/mL or more 16) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the agency's normal limit 17) A person whose creatine is more than 1.5 times the normal upper limit of the implementation agency 18) A person who has participated in other interventional clinical trials (including human-applied trials) within three months of the visit 1 or who plans to participate in other interventional clinical trials (including human-applied trials) during this human-applied trial period 19) A person who is pregnant or has a pregnancy plan during this human body application test, or a lactating woman 20) A person who is sensitive or allergic to food ingredients for this human application test 21) A person who judges that the tester is inappropriate for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NK Cell Activity Change(Effector Cell: Target Cell = 50:1, 25:1, 12.5:1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cytokine(IFN-?, IL-2, IL-4, IL-6, IL-12, TNF-a);WBC Count;NK T Cell Count;CD4+/CD8+ Ratio;Lymphocyte Count | — |
Countries
Korea, Republic of
Contacts
Public ContactJu Hee Lee
Yonsei University Health System, Severance Hospital
Outcome results
None listed