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This study was conducted to investigate the efficacy and safety of SGF200 on immune enhancement.
This study was a 8 weeks, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into SGF200 group or placebo group. The investigators measured Natural Killer cell activity, Cytokines(IL-2, IL-12, IFN-γ, TNF-α), questionnaire scores of upper airway infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGF200 group | Experimental | 1 times a day, 1 capsule for 1 time, before breakfast meal[350 mg/day (Bacillus amyloliquefaciens spore 1x10^9 CFU/day, GF101 200 U/day)] |
|
| placebo group | Placebo Comparator | 1 times a day, 1 capsule for 1 time, before breakfast meal[350 mg/day (Bacillus amyloliquefaciens spore 0 CFU/day, GF101 0 U/day)] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGF200 group | Dietary Supplement | 1 times a day, 1 capsule for 1 time, before breakfast meal, for 8 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Natural Killer cell activity | Natural Killer cell activity was measured in study baseline and 8 week. A ratio of effector cell and target cell was 2.5:1, 5:1, 10:1 (Experimental - Effector Spontaneous - Target Spontaneous) / (Target Maximum - Target Spontaneous) × 100 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Cytokines | For blood Cytokines analysis, collect 3 ml of blood in one SST tube for 5 ml, leave at room temperature for 30 minutes for clotting, after then centrifuge at 3000 rpm (or 2000 xg) for 10 minutes. Inspection item were IL-2, IL-12, IFN-γ, TNF-α. | 8 weeks |
| Changes of Wisconsin Upper Respiratory Symptom Survey-21 |
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Inclusion Criteria:
Exclusion Criteria:
If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
Those who received influenza vaccination within 3 months before first intake for test product
Those who have a body mass index(BMI) of less than 18.5 kg / m^2 or greater than 35 kg / m^2 at the screening
Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic
Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
Those who have received antipsychotic medication within 3 months before screening
Those who alcoholic or drug abuse suspected
Those who participated in other clinical trials within 3 months before screening
Laboratory test by show the following results
Pregnancy or breast feeding
Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 54907 | South Korea |
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| Placebo | Dietary Supplement | Placebo for 8 week |
|
Wisconsin Upper Respiratory Symptom Survey-21 consists of seven steps, including individual symptoms, functional quality of life, and overall improvement. Find the sum of the symptom questions and give them the total score. Seek, sum up the questions of life, and get the total quality of life. The sum of the total score of symptoms and the total score of quality of life is also obtained. |
| 8 weeks |