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This study was conducted to investigated the effects of daily supplementation of Blueberry Yeast Fermentation Freeze Dying Powder on Promotion of Immunity.
This study was a 8-week, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into Blueberry Yeast Fermentation Freeze Dying Powder extract 2.07 g or placebo group. The investigated measured Natural Killer cell activity, Cytokines, Upper respiratory infection questionnaire score, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blueberry Yeast Fermentation Freeze Dying Powder Extract | Experimental | Blueberry Yeast Fermentation Freeze Dying Powder Extract 2.07 g/day for 8 weeks. |
|
| Placebo | Placebo Comparator | Placebo 2.07 g/day for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blueberry Yeast Fermentation Freeze Dying Powder Extract | Dietary Supplement | Blueberry Yeast Fermentation Freeze Dying Powder Extract 2.07 g/day for 8 weeks. |
|
| 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 50:1, 25:1, 12.5:1. (Experimental - Effector Spontaneous - Target Spontaneous) / (Target Maximum - Target Spontaneous) × 100 | 8 week |
| 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-6, IL-12, IFN-γ, TNF-α. | 8 week |
| Changes of Upper respiratory infection questionnaire score |
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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 the screening
Those who have a body mass index(BMI) of less than 18.5 kg / m2 or greater than 35 kg / m2 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 2.07 g/day for 8 weeks. |
|
The upper respiratory infection questionnaire will investigate the occurrence of symptoms of upper respiratory infections (or symptoms), the score by symptom, the duration (days), and survey on the day of visit (1st, 2nd and 3rd visits). The questionnaire items were classified into three groups according to whether or not the symptoms of upper respiratory infections (or symptoms) occurrence (yes or no), the types of symptoms (sore throat, rhinorrhea, nasal obstruction, sneezing, hoarseness, myalgia, earache, fever, headache, cough, sputum, dyspnea, diarrhea, nausea, vomiting)and symptoms level (0 if no symptoms, 1 if slightly, 2 if normal, 3 severe). |
| 8 week |