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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
45
2 times a day, 1 pack for 1 time, after breakfast/dinner meal(6 g/day, Soybean paste 6 g/day) for 4 weeks
2 times a day, 1 pack for 1 time, after breakfast/dinner meal(6 g/day, Soybean paste 6 g/day) for 4 weeks
2 times a day, 1 pack for 1 time, after breakfast/dinner meal(6 g/day, Soybean paste 6 g/day) for 4 weeks
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Changes in intestinal microflora
Put more than 1 g of feces in the fecal kit, and perform analysis
Time frame: 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
Time frame: baseline and 4 weeks
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.
Time frame: 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.
Time frame: baseline and 4 weeks
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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).
Time frame: 4 weeks