Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTSoybean Germ Extract
Soybean Germ Extract 1,600 mg/day for 12 weeks.
DIETARY_SUPPLEMENTPlacebo
Placebo 1,600 mg/day for 12 weeks.
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of body fat mass | Baseline and 12 week | Body fat mass was measured in study baseline and 12 week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of fat free mass | Baseline and 12 week | 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. |
| Changes of Anthropometric indicate: body weight | Screening, baseline and 12 week | Anthropometric indices were measured in study screening, baseline and 12 week. Body weight in kg. |
| Changes of Anthropometric indicate: body mass index | Screening, baseline and 12 week | Anthropometric indices were measured in study screening, baseline and 12 week. Weight/height\^2 will be report body mass index in kg/m\^2. |
| Changes of Anthropometric indices: waist circumference, hip circumference | Screening, baseline and 12 week | Anthropometric indices were measured in study screening, baseline and 12 week. Waist circumference, hip circumference in cm. |
| Changes of percent body fat | Baseline and 12 week | 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 %. |
| Changes of lipid metabolism indicators: Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol | Baseline and 12 week | Lipid metabolism indicators(mg/dL) were measured in study baseline and 12 week. |
| Changes of obesity-related hormones indicators: Adiponectin, Leptin | Baseline and 12 week | obesity-related hormones indicators were measured in study 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 | energy expenditure Indicators were measured in study baseline and 12 week |
| Changes of Anthropometric indicate: waist -hip circumference ratio | Screening, baseline and 12 week | Anthropometric indices were measured in study screening, baseline and 12 week. Waist circumference/hip circumference will be report waist -hip circumference ratio. |
Countries
South Korea
Contacts
Primary ContactSoo Wan Chae, Ph.D., M.D.
Outcome results
None listed