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

Chonbuk National University

Status: Completed

Conditions: Immunity

Treatments: Dietary Supplement: TFD21-1 group; Dietary Supplement: TCD21-55 group; Dietary Supplement: TMD21-16 group

Study type: Interventional

Funder types: Other

Identifiers

NCT05190237

MIFI-IE-FS

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups, including a placebo group

TMD21-16 group

Experimental group

Description:

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)

Treatment:

Dietary Supplement: TMD21-16 group

TCD21-55 group

Experimental group

Description:

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)

Treatment:

Dietary Supplement: TCD21-55 group

TFD21-1 group

Placebo Comparator group

Description:

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)

Treatment:

Dietary Supplement: TFD21-1 group