the Efficacy and Safety of Fermented Soybean(Doenjang Powder) on Intestinal Microflora and Immune Enhancement.
NCT ID: NCT05190237
Last Updated: 2022-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2021-11-19
2022-02-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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)
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
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)
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
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)
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
Interventions
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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
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
19 Years
75 Years
ALL
No
Sponsors
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Chonbuk National University Hospital
OTHER
Responsible Party
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Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Locations
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Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Countries
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Other Identifiers
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MIFI-IE-FS
Identifier Type: -
Identifier Source: org_study_id
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