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

NCT05190237 | Completed DMC

• 1 other identifier: MIFI-IE-FS
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Immunity

Keywords

Fermented Soybean(Doenjang); Immunity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Changes of Interleukin-2, Interleukin-12, Interferon-Gamma and Tumor necrosis factor-alpha

  baseline and 4 weeks

• Wisconsin Upper Respiratory Symptom Survey-21(WURSS-21)

  baseline and 4 weeks

• Patient global assessment(PGA)

  4 weeks

Study Arms (3)

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)

Dietary Supplement: TMD21-16 group

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)

Dietary Supplement: TCD21-55 group

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)

Dietary Supplement: TFD21-1 group

Interventions

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

TMD21-16 group

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

TCD21-55 group

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

TFD21-1 group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 13, 2022
• Study Start: November 19, 2021
• Primary Completion: December 24, 2021
• Study Completion: February 7, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Locations

KR (1)