Clinical trial NCT03826212: Efficacy and Safety of Soybean Germ Extract on Decrease of Body Fat
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Changes of body fat mass
timeFrame: Baseline and 12 week
Secondary outcomes:
measure: Changes of percent body fat
timeFrame: Baseline and 12 week
measure: Changes of fat free mass
timeFrame: Baseline and 12 week
measure: Changes of Anthropometric indicate: body weight
timeFrame: Screening, baseline and 12 week
measure: Changes of Anthropometric indicate: body mass index
timeFrame: Screening, baseline and 12 week
measure: Changes of Anthropometric indices: waist circumference, hip circumference
timeFrame: Screening, baseline and 12 week
measure: Changes of Anthropometric indicate: waist -hip circumference ratio
timeFrame: Screening, baseline and 12 week
measure: Changes of lipid metabolism indicators: Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol
timeFrame: Baseline and 12 week
measure: Changes of obesity-related hormones indicators: Adiponectin, Leptin
timeFrame: Baseline and 12 week
measure: Changes of energy expenditure Indicators: Uncoupling protein-1(UCP-1), Peroxisome proliferator-activated receptor gamma coactivator-1 α(PGC-1 α)
timeFrame: Baseline and 12 week
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References: