None listed
Conditions
Interventions
Dietary Supplement : Treatment group: 1 tablet, once a day (300 mg as purified protein extract from whey(Lactoferrin))
Control group: 1 tablet, once a day (0 mg as purified protein extract from whey(
Sponsors
Lion Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) General adult (men and women) between the ages of 20 and 80 2) A person whose WBC is less than 3x10 3 cells/µL or greater than 8 x10 3 cells/µL in the screening test. 3) Those who meet one or more of the following criteria ? Those who have had symptoms of upper respiratory infection (Common cold, Tonsillitis, Pharyngitis, Laryngitis, Rhinitis etc.) more than twice within 1 year before the screening test ? Those who have had symptoms of herpes zoster more than twice within 1 year before the screening test ? Those who have had symptoms of stomatitis more than twice within 1 year before the screening test 4) Those who have a high score(> 16) on the Perceived Stress Scale (PSS) 5) A person who agrees to participate in the human application test and completes a written informed consent form before the human application test begins
Exclusion criteria
Exclusion criteria: 1) At the time of screening, any disease that may affect immunity (e.g., leukemia, autoimmune disease, inflammatory systemic disease, metabolic syndrome, infectious disease, or conditions (e.g., Such as malnutrition) 2) Have clinically significant endocrine, respiratory or musculoskeletal disorders requiring medical treatment 3) Severe brain disease (e.g. stroke, cerebral infarction, cerebral hemorrhage, etc.) or heart disease (e.g. cardiovascular disease, arrhythmia, heart failure, myocardial infarction, history of pacemaker use) 4) Participants with uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg, measured after 10 minutes of rest). 5) Fasting blood glucose =126 mg/dL or starting antidiabetic medication(Oral hypoglycemic agents, insulin, etc.) 6) TSH lower than 0.1µIU/ml or upper than 10 µIU/ml 7) Immunizations (Influenza, COVID-19, Herpes Zoster, etc.) within 2 months before screening 8) AST(GOT) and ALT(GPT) is at least twice the normal range 9) Creatinine is at least twice the normal range 10) Those who have consumed medicine(e.g., immunosuppressants, antibiotics, steroids, anti-inflammatory drugs, antihistamines, etc.) or health supplements related to immune function(e.g., Products containing individually approved or notified raw materials such as perilla leaf extract, silk protein acid hydrolyzate Sil Q1, beta-glucan powder, red ginseng, zinc, et) within 2 weeks before screening 11) Those who consumed more than 1,000 ml/day of milk or related products 12) Those with a history of gastrointestinal diseases (e.g., Crohn's disease, Gastric bypass surgery, irritable bowel syndrome) or Those with a history of milk products(e.g., lactoferrin) significant hypersensitivity reactions 13) Pregnant or lactating women or subjects planning to become pregnant during the clinical trial period 14) Individuals who have participated in another clinical trial within 8 weeks before the start of the current trial or plan to participate in another trial during the course of the current trial 15) Individuals sensitive to or allergic to ingredients related to the test food for the human clinical trial 16) BMI(Body Mass Index) greater than 30 kg/m2 17) Those who have consumed excessive amounts of alcohol within 1 month (30 days) prior to Visit 1(man 210g/week, women 140g/week) 18) Individuals judged by the participant to be unsuitable for the current human clinical trial 19) Those who plan or are expected to use concomitant non-drugs or therapies during the clinical trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Natural Killer Cell activity | — |
Secondary
| Measure | Time frame |
|---|---|
| Cytokine(IFN-?, TNF-a, IL-6, IL-10, IL-12);WBC Count;The frequency of upper respiratory tract infections;FSS (Fatigue Severity Scale);Assessment of improvement of subjects and testers | — |
Countries
Korea, Republic of
Contacts
Public ContactJang min woo
Pusan National University Hospital
Outcome results
None listed