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Completed

NCT Number: NCT05190237

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.

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Key information

Conditions

Immunity

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

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

Primary outcomes

  1. Changes in intestinal microflora

    Time frame: baseline and 4 weeks

    Put more than 1 g of feces in the fecal kit, and perform analysis

  2. Changes of Natural Killer cell activity

    Time frame: 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

Secondary outcomes

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

    Time frame: 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.

  2. Wisconsin Upper Respiratory Symptom Survey-21(WURSS-21)

    Time frame: 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.

  3. Patient global assessment(PGA)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 13, 2022
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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