None listed
Conditions
Interventions
Dietary Supplement : Subjects are randomly allocated to either experimental or placebo group and take test materials (Undaria pinnatifida Sporophyll extract 500mg/day) or placebo twice a day, each tim
Sponsors
Duksung Women's University
Naturalendo Tech
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women aged 20 to 75 years old 2) Peripheral blood WBC of 3×10^3/µl or more and less than 8×10^3/µl in the screening test 3) Those whose awareness of Stress Self-Assessment scale is above “strong” (4 scales: None, Moderate, Strong, Intense) 4) Those who have had upper respiratory tract infections* more than two times within one year before the start of the test {*cough, tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, etc} 5) A person who has agreed to participate in this test and signed a written consent form by the subject (or legal representative) voluntarily
Exclusion criteria
Exclusion criteria: 1) Those who have been treated or are currently being treated for clinically significant acute or chronic endocrine system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal disease, psychotic, infectious diseases, etc. 2) Those who suffer from immune system disease (AIDS, autoimmune disease, systemic lupus erythematosus, sjogren's syndrome, etc.) 3) Those who suffer from severe cardiovascular diseases (stroke, hemorrhage, etc), and sever heart diseases (angina, myocardial infarction, heart failure, arrhythmia requiring treatments) or malignant tumor, etc. 4) Those with uncontrolled hypertension (160/100mmHg or more, measured after 10 minutes of rest for the subject) 5) Subjects who have got a vaccination within 3 months before screening. 6) Those whose AST(GOT) or ALT(GPT) blood level is 3 times or more than the normal upper limit of the relevant organ. 7) Those whose creatinine blood level is more than the normal upper limit. 8) Those who have consumed or are ingesting health functional foods that may affect immunity within 2 weeks before screening. 9) Those who complain of gastrointestinal symptoms such as heartburn and indigestion. 10) Those who are pregnant, lactating or planning to become pregnant during the study period. 11) Those who have participated in other studies within 3 months before screening, or plan to participate in others during this study. 12) Those who the researcher deems unsuitable for this study. 13) Those who are sensitive or allergic to test food.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Natural killer cell activity (2.5:1, 5:1, 10:1) | — |
Secondary
| Measure | Time frame |
|---|---|
| blood test: IFN-?, TNF-a, IL-1ß, IL-2, IL-6, IL-10, IgG, IgM (Multiplex);White blood cell count;The degree of infection, duration, and incidence of the upper respiratory tract infection;??????;Evaluation of improvement by the test subjects themselves;Adverse events;clinical laboratory test(hematologic/chemistry examination, Urinalysis);Vital Sign(pulsus, arteriotony) , Physical measurement (Weight);electrocardiography | — |
Countries
Korea, Republic of
Contacts
Public ContactHee Yeon Jang
Jeonbuk National University Hospital
Outcome results
None listed