Efficacy and Safety of Soybean Germ Extract on Decrease of Body Fat
NCT ID: NCT03826212
Last Updated: 2019-07-24
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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UNKNOWN
NA
80 participants
INTERVENTIONAL
2019-06-03
2020-02-28
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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Soybean Germ Extract
Soybean Germ Extract 1,600 mg/day for 12 weeks.
Soybean Germ Extract
Soybean Germ Extract 1,600 mg/day for 12 weeks.
Placebo
Placebo 1,600 mg/day for 12 weeks.
Placebo
Placebo 1,600 mg/day for 12 weeks.
Interventions
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Soybean Germ Extract
Soybean Germ Extract 1,600 mg/day for 12 weeks.
Placebo
Placebo 1,600 mg/day for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* BMI 25\~29.9 kg/m\^2
* 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 take a product(body fat improvement health functional foods, birth control pills, steroids, female hormone) that affects your weight within 4 weeks prior to the screening
* Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
* Diabetic patients taking oral hypoglycemic agents or insulin (based on screening subjects)
* A person with a history of clinically significant hypersensitivity to soybeans
* Those who have received antipsychotic medication within 2 months before screening
* Anyone with substance abuse or suspicion
* Those who participated in other clinical trials within 3 months before screening
* Systolic Blood Pressure(SBP) 180 mmHg, Diastolic Blood Pressure(DBP) 110 mmHg or more
* Menopausal woman
* 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
65 Years
ALL
Yes
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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Central Contacts
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Facility Contacts
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Other Identifiers
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NOVA-BF-SBG
Identifier Type: -
Identifier Source: org_study_id
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