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This study was conducted to investigate the effects of daily supplementation of Soybean germ extract on decrease of body fat
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soybean Germ Extract | Experimental | Soybean Germ Extract 1,600 mg/day for 12 weeks. |
|
| Placebo | Placebo Comparator | Placebo 1,600 mg/day for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soybean Germ Extract | Dietary Supplement | Soybean Germ Extract 1,600 mg/day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of body fat mass | Body fat mass was measured in study baseline and 12 week | Baseline and 12 week |
| 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 |
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Inclusion Criteria:
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
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Wan Chae, Ph.D., M.D. | Contact | 82-63-259-3040 | soowan@jbnu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods Chonbuk National University Hospital | Recruiting | Jeonju | Jeollabuk-do | 54907 | South Korea |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Dietary Supplement | Placebo 1,600 mg/day for 12 weeks. |
|
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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |