None listed
Conditions
Interventions
Dietary Supplement : The test product contains fermented noni polysaccharides as the main ingredient, and its form and dosage type is a tablet. Each tablet contains 487.5 mg of the active ingredient.
Sponsors
Semyung University Oriental Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female participants aged 40 to 75 years. 2) Individuals with a peripheral white blood cell count between 4×10³ cells/µL and 8×10³ cells/µL at screening. 3) Individuals who have experienced two or more upper respiratory infections (e.g., common cold, tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis) within one year prior to the screening visit. 4) Individuals who voluntarily agree to participate in the study and sign the written informed consent form.
Exclusion criteria
Exclusion criteria: 1) Individuals who have had, within 1 month prior to the screening visit, or currently have any disease or condition that may affect the immune system (e.g., infectious diseases, autoimmune diseases, leukemia, immune thrombocytopenia, malignancy, liver disease including active hepatitis, metabolic syndrome, inflammatory diseases, or significant malnutrition). 2) Individuals who have taken or are currently taking health functional foods that may influence immune function within 1 month prior to the screening visit (e.g., vitamins, probiotics, ginseng, red ginseng, or other immune-enhancing supplements). 3) Individuals who have taken or are currently taking immunosuppressants, antibiotics, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or antihistamines within 3 months prior to the screening visit. 4) Individuals who have received any vaccination within 3 months prior to the screening visit. 5) Individuals with confirmed COVID-19 infection within 3 months prior to the screening visit. 6) Individuals with uncontrolled hypertension (blood pressure =160/100 mmHg after a 10-minute rest). 7) Individuals with uncontrolled diabetes (fasting blood glucose =126 mg/dL or HbA1c =6.5%), or individuals who have initiated or changed diabetes treatment within 3 months prior to the screening visit. 8) Individuals whose serum creatinine level is greater than 2.0 mg/dL at the screening assessment. 9) Individuals whose AST or ALT levels exceed three times the upper limit of normal at the screening assessment. 10) Individuals currently receiving treatment for severe cardiovascular, immune, respiratory, hepatobiliary, renal/urinary, neurologic, musculoskeletal, psychiatric, infectious diseases, or malignancies. 11) Individuals who have had, within 3 months prior to the screening visit, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (e.g., angioplasty or stent insertion), active unstable angina, heart failure classified as NYHA Class III or IV, severe valvular disease (e.g., aortic or mitral stenosis), stroke, or untreated atrial fibrillation. 12) Individuals with gastrointestinal diseases that may affect absorption of the study product (e.g., Crohn’s disease, chronic digestive disorders, irritable bowel syndrome), or with a history of gastrointestinal surgery within 6 months prior to the screening visit. 13) Individuals with thyroid disorders (thyroid dysfunction or abnormal thyroid hormone levels). 14) Individuals who consume more than 210 g/week (men) or 140 g/week (women) of alcohol during the past month, based on the alcohol intake questionnaire. 15) Individuals who are heavy smokers (=20 cigarettes/day). 16) Individuals who are pregnant, breastfeeding, or planning to become pregnant during the study period. 17) Individuals with known hypersensitivity or allergy to any component of the study product. 18) Individuals who have participated in a similar clinical trial within 3 months prior to the screening visit. 19) Individuals deemed unsuitable for study participation for any other reason at the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NK cell activity | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in cytokine levels (IFN-?, TNF-a, IL-2, IL-6, IL-10, IL-12, IL-1ß);Changes in IgG;Changes in the Global Assessment of Recent Stress (GARS) scale score;Incidence of upper respiratory infections;Changes in WBC count, neutrophil percentage, and lymphocyte percentage | — |
Countries
Korea, Republic of
Contacts
Public ContactSeong Hwan Park
Semyung University Oriental Medicine Hospital
Outcome results
None listed