None listed
Conditions
Interventions
Dietary Supplement : Subjects will be randomly assigned to one of two study groups and will orally take two capsules of either the test food or the control food once daily with sufficient water for 8
Sponsors
Fine BS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women aged 19 to 80 years at the time of screening. 2) Subjects with a white blood cell (WBC) count between 3 × 10³ cells/µL and 8 × 10³ cells/µL, as determined at screening. 3) Subjects who have experienced symptoms of upper respiratory tract infection on at least two occasions within 1 year prior to screening. 4) Subjects who are able to understand the purpose, procedures, and requirements of the study and are capable of complying with the study protocol. 5) Subjects who voluntarily agree to participate in the study and provide written informed consent prior to any study-related procedures.
Exclusion criteria
Exclusion criteria: 1) Subjects with immune-related diseases. 2) Subjects with a history of or current cancer. 3) Subjects with a history of cardiovascular disease, arrhythmia, heart failure, myocardial infarction, or cardiac pacemaker implantation. 4) Subjects with gastrointestinal diseases (e.g., Crohn’s disease), a history of gastrointestinal resection surgery, or irritable bowel syndrome. 5) Subjects with hepatic, renal, pulmonary/respiratory, or musculoskeletal diseases. 6) Subjects with neurological or psychiatric disorders, or those who have received psychological treatment. 7) Subjects with thyroid disease or clinically significant abnormal thyroid function. 8) Subjects with clinically significant hypertension. 9) Subjects with clinically significant diabetes mellitus. 10) Subjects with clinically significant metabolic syndrome. 11) Subjects who have received vaccination within 1 month prior to screening. 12) Subjects who have been diagnosed with COVID-19 within 1 month prior to screening or have received a COVID-19 vaccination within 3 months prior to screening. 13) Subjects with severe gastrointestinal symptoms such as heartburn or dyspepsia. 14) Subjects who have undergone surgery within 6 months prior to screening. 15) Subjects with a history of drug addiction, drug abuse, or suspected drug abuse. 16) Subjects with clinically significant allergies. 17) Pregnant or lactating women, or those planning to become pregnant during the study period. 18) Subjects with known allergies or adverse reactions to any ingredient contained in the test food or control food. 19) Subjects with alcoholism or habitual excessive alcohol consumption. 20) Subjects who are excessive smokers. 21) Subjects who have received immunosuppressants or corticosteroids within 1 month prior to screening. 22) Subjects who have taken medications or health functional foods related to immune enhancement within 3 months prior to screening. 23) Subjects who have participated in another human study or clinical trial within 1 month prior to screening, or who plan to participate in another study during the study period. 24) Subjects with clinically significant abnormal laboratory test results. 25)Subjects who are considered unsuitable for participation in the study by the Principal Investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NK cell activity | — |
Secondary
| Measure | Time frame |
|---|---|
| cytokines;immune biomarkers;questionnaire assessments;clinical laboratory tests;adverse event assessment;vital signs;Electrocardiogram | — |
Countries
Korea, Republic of
Contacts
Public Contactmisuk kang
Hallym University Medical Center
Outcome results
None listed