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

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.

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

Study Overview

• Status: Completed
• Conditions: Immunity
• Intervention / Treatment: Dietary supplement: TMD21-16 group; Dietary supplement: TCD21-55 group; Dietary supplement: TFD21-1 group

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Actual): December 24, 2021
• Study Completion (Actual): February 7, 2022

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: January 9, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Immunity; Fermented Soybean(Doenjang)
• Other Study ID Numbers: MIFI-IE-FS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No