Efficacy and Safety of Soybean Germ Extract on Decrease of Body Fat

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.

Official Title
-----------------
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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Soybean Germ Extract
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soybean Germ Extract<br>Soybean Germ Extract 1,600 mg/day for 12 weeks. | Dietary Supplement: Soybean Germ Extract<br>* Soybean Germ Extract 1,600 mg/day for 12 weeks.<br>|
| Placebo Comparator: Placebo<br>Placebo 1,600 mg/day for 12 weeks. | Dietary Supplement: Placebo<br>* Placebo 1,600 mg/day for 12 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of body fat mass | Body fat mass was measured in study baseline and 12 week | Baseline and 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of percent body fat | Measurement is made using dual energy X-ray absorptiometry (DEXA / Hologic Discovery, USA). Left arm, right arm, left leg, right leg, trunk, total will be report percent body fat in %. | Baseline and 12 week | 
| Changes of fat free mass | Measurement is made using dual energy X-ray absorptiometry (DEXA / Hologic Discovery, USA). Left arm, right arm, left leg, right leg, trunk, total will be report fat free mass in g. | Baseline and 12 week | 
| Changes of Anthropometric indicate: body weight | Anthropometric indices were measured in study screening, baseline and 12 week. Body weight in kg. | Screening, baseline and 12 week | 
| Changes of Anthropometric indicate: body mass index | Anthropometric indices were measured in study screening, baseline and 12 week. Weight/height^2 will be report body mass index in kg/m^2. | Screening, baseline and 12 week | 
| Changes of Anthropometric indices: waist circumference, hip circumference | Anthropometric indices were measured in study screening, baseline and 12 week. Waist circumference, hip circumference in cm. | Screening, baseline and 12 week | 
| Changes of Anthropometric indicate: waist -hip circumference ratio | Anthropometric indices were measured in study screening, baseline and 12 week. Waist circumference/hip circumference will be report waist -hip circumference ratio. | Screening, baseline and 12 week | 
| Changes of lipid metabolism indicators: Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol | Lipid metabolism indicators(mg/dL) were measured in study baseline and 12 week. | Baseline and 12 week | 
| Changes of obesity-related hormones indicators: Adiponectin, Leptin | obesity-related hormones indicators were measured in study baseline and 12 week | 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) | energy expenditure Indicators were measured in study baseline and 12 week | Baseline and 12 week |