the Efficacy and Safety of Fermented Soybean(Doenjang Powder) on Intestinal Microflora and Immune Enhancement.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Immunity

Intervention / Treatment
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* Dietary Supplement: TMD21-16 group
* Dietary Supplement: TCD21-55 group
* Dietary Supplement: TFD21-1 group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men and women over 19 and under 75 years After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice 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 Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit Serum Creatinine > 2.0 mg/dL 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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMD21-16 group<br>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) | Dietary Supplement: TMD21-16 group<br>* 2 times a day, 1 pack for 1 time, after breakfast/dinner meal(6 g/day, Soybean paste 6 g/day) for 4 weeks<br>|
| Experimental: TCD21-55 group<br>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) | Dietary Supplement: TCD21-55 group<br>* 2 times a day, 1 pack for 1 time, after breakfast/dinner meal(6 g/day, Soybean paste 6 g/day) for 4 weeks<br>|
| Placebo Comparator: TFD21-1 group<br>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) | Dietary Supplement: TFD21-1 group<br>* 2 times a day, 1 pack for 1 time, after breakfast/dinner meal(6 g/day, Soybean paste 6 g/day) for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fermented Soybean(Doenjang), Immunity