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This study was conducted to investigate the efficacy and safety of Fermented soybean(Doenjang powder) on intestinal microflora and immune enhancement.
This study was a 4 weeks, randomized, double-blind human trial to evaluate the efficacy and safety of Fermented soybean(Doenjang powder) on intestinal microflora and immune enhancement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMD21-16 group | Experimental | Effective Microorganisms high content soybean paste powder group - 2 times a day, 1 pack for 1 time, after breakfast/dinner meal(6 g/day, Soybean paste 6 g/day) |
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| TCD21-55 group | Experimental | Effective Microorganisms low content soybean paste powder group - 2 times a day, 1 pack for 1 time, after breakfast/dinner meal(6 g/day, Soybean paste 6 g/day) |
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| TFD21-1 group | Placebo Comparator | Commercial soybean paste powder group - 2 times a day, 1 pack for 1 time, after breakfast/dinner meal(6 g/day, Soybean paste 6 g/day) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMD21-16 group | Dietary Supplement | 2 times a day, 1 pack for 1 time, after breakfast/dinner meal(6 g/day, Soybean paste 6 g/day) for 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in intestinal microflora | Put more than 1 g of feces in the fecal kit, and perform analysis | baseline and 4 weeks |
| Changes of Natural Killer cell activity | Natural Killer cell activity was measured in study baseline and 4 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 | baseline and 4 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 4 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 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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| 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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| TCD21-55 group | Dietary Supplement | 2 times a day, 1 pack for 1 time, after breakfast/dinner meal(6 g/day, Soybean paste 6 g/day) for 4 weeks |
|
| TFD21-1 group | Dietary Supplement | 2 times a day, 1 pack for 1 time, after breakfast/dinner meal(6 g/day, Soybean paste 6 g/day) for 4 weeks |
|
| Wisconsin Upper Respiratory Symptom Survey-21(WURSS-21) | The Wisconsin Upper Respiratory Symptom Survey-21 will investigate on the day of visit(visit 1,2). 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. All items of symptom score rank on a seven-point scale(1=very mild and 7=severe), where a higher score means higher severity. The symptom score ranges from 0(Do not have this symptom) to 70. All items of quality of life score rank on a seven-point scale(1=very mildly and 7=severely), where a higher score means higher severity. The quality of life score ranges from 0(Not at all) to 63. Therefore, the total score ranges from 0 to 133. | baseline and 4 weeks |
| Patient global assessment(PGA) | It is a questionnaire in which the study subjects self-evaluate the degree of improvement in immunity improvement 4 weeks after intake compared to before and after intake of human-applied test products. A total of five-step evaluation criteria are used for evaluation, and they are evaluated as very good (1), good (2), constant (3), bad (4), and very bad (5). | 4 weeks |