NCT03826212UnknownNot Applicable
A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Soybean Germ Extract on Decrease of Body Fat
Chonbuk National University Hospital1 site in 1 country80 target enrollmentStarted: June 3, 2019Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Changes of body fat mass
Study Overview
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 Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and body mass index, etc.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Soybean Germ Extract
Experimental
Soybean Germ Extract 1,600 mg/day for 12 weeks.
Intervention: Soybean Germ Extract (Dietary Supplement)
Placebo
Placebo Comparator
Placebo 1,600 mg/day for 12 weeks.
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Changes of body fat mass
Time Frame: Baseline and 12 week
Body fat mass was measured in study baseline and 12 week
Secondary Outcomes
- Changes of Anthropometric indicate: body weight(Screening, baseline and 12 week)
- Changes of energy expenditure Indicators: Uncoupling protein-1(UCP-1), Peroxisome proliferator-activated receptor gamma coactivator-1 α(PGC-1 α)(Baseline and 12 week)
- Changes of Anthropometric indices: waist circumference, hip circumference(Screening, baseline and 12 week)
- Changes of lipid metabolism indicators: Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol(Baseline and 12 week)
- Changes of percent body fat(Baseline and 12 week)
- Changes of fat free mass(Baseline and 12 week)
- Changes of Anthropometric indicate: body mass index(Screening, baseline and 12 week)
- Changes of Anthropometric indicate: waist -hip circumference ratio(Screening, baseline and 12 week)
- Changes of obesity-related hormones indicators: Adiponectin, Leptin(Baseline and 12 week)
Investigators
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital
Study Sites (1)
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