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 enrollmentJune 3, 2019

ConditionsObesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: Chonbuk National University Hospital
Enrollment: 80
Locations: 1
Primary Endpoint: Changes of body fat mass
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 3, 2019

End Date

February 28, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chonbuk National University Hospital

Responsible Party

Principal Investigator

Soo-Wan Chae

Principal Investigator, Clinical Trial Center for Functional Foods

Chonbuk National University Hospital

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

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)