Status:
UNKNOWN
Efficacy and Safety of Soybean Germ Extract on Decrease of Body Fat
Lead Sponsor:
Chonbuk National University Hospital
Conditions:
Obesity
Eligibility:
All Genders
19-65 years
Phase:
NA
Brief Summary
This study was conducted to investigate the effects of daily supplementation of Soybean germ extract on decrease of body fat
Detailed Description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into Soybean germ extract 1,600 mg or placebo group. The investigators measured B...
Eligibility Criteria
Inclusion
- age between 19 and 65 years
- 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
- Those who lost more than 10% of their weight within 3 months before the screening
- 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.
Key Trial Info
Start Date :
June 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03826212
Start Date
June 3 2019
End Date
February 28 2020
Last Update
July 24 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea, 54907