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

Not Applicable

Completed

• Conditions: Immunity
• Interventions: Dietary Supplement: TCD21-55 group; Dietary Supplement: TFD21-1 group; Dietary Supplement: TMD21-16 group

• Registration Number: NCT05190237
• Lead Sponsor: Chonbuk National University Hospital

Brief Summary

This study was conducted to investigate the efficacy and safety of Fermented soybean(Doenjang powder) on intestinal microflora and immune enhancement.

Detailed Description

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 Timeline

• Study Start: 2021-11-19
• Study First Submitted: 2021-12-22
• Primary Completion: 2021-12-24
• Study First Submitted QC: 2022-01-09
• Study First Posted: 2022-01-13
• Status Verified: 2022-02
• Study Completion: 2022-02-07
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCD21-55 group	TCD21-55 group	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)
TFD21-1 group	TFD21-1 group	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)
TMD21-16 group	TMD21-16 group	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)

Primary Outcome Measures

Name	Time	Method
Changes of Natural Killer cell activity	baseline and 4 weeks	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
Changes in intestinal microflora	baseline and 4 weeks	Put more than 1 g of feces in the fecal kit, and perform analysis

Secondary Outcome Measures

Name	Time	Method
Changes of Interleukin-2, Interleukin-12, Interferon-Gamma and Tumor necrosis factor-alpha	baseline and 4 weeks	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.
Wisconsin Upper Respiratory Symptom Survey-21(WURSS-21)	baseline and 4 weeks	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.
Patient global assessment(PGA)	4 weeks	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).

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of