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This study was conducted to investigate the efficacy and safety of Black rice bran extract on immune enhancement.
This study was a 8 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Black rice bran extract on immune enhancement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Black rice bran extract group | Experimental | 2 times a day, 2 capsule for 1 time, after breakfast/dinner meal(1.52 g/day, Black rice bran extract 1 g/day) |
|
| Placebo group | Placebo Comparator | 2 times a day, 2 capsule for 1 time, after breakfast/dinner meal(1.52 g/day, Black rice bran extract 0 g/day) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Black rice bran extract | Dietary Supplement | 2 times a day, 2 capsule for 1 time, after breakfast/dinner 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 | baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Interleukin-2, Interleukin-12, Interferon-Gamma and Tumor necrosis factor-alpha | For blood Interleukin-2, Interleukin-12, Interferon-Gamma and Tumor necrosis factor-alpha analysis, collect 3 ml of blood in one serum separate 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. | baseline and 8 weeks |
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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 of intervention
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 and gastrointestinal disorders
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Wan Chae, Ph.D., M.D. | Contact | 82-63-259-3040 | soowan@jbnu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods Chonbuk National University Hospital | Recruiting | Jeonju | Jeollabuk-do | 54907 | South Korea |
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| Placebo | Dietary Supplement | 2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week |
|
| Changes of Wisconsin Upper Respiratory Symptom Survey-21(WURSS-21) | The Wisconsin Upper Respiratory Symptom Survey-21 will investigate on the day of visit (1st, 2nd and 3rd visits). The Wisconsin Upper Respiratory Symptom Survey-21 consists of seven stages, including individual symptoms, functional quality of life, and overall improvement. Find the total score of symptoms by obtaining the sum of symptom questions, and the total score of quality of life by obtaining the sum of life questions. Additionally, the sum of the total points of symptoms and quality of life is obtained.
| baseline, 4 weeks and 8 weeks |