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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03826212
• Other study ID #: NOVA-BF-SBG
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: July 2019
• Source: Chonbuk National University Hospital
• Contact: Soo Wan Chae, Ph.D., M.D.
• Phone: 82-63-259-3040
• Email: soowan[@]jbnu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted to investigate the effects of daily supplementation of Soybean germ extract on decrease of body fat

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Soybean Germ Extract
Soybean Germ Extract 1,600 mg/day for 12 weeks.
• Placebo
Placebo 1,600 mg/day for 12 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of body fat mass	Body fat mass was measured in study baseline and 12 week	Baseline and 12 week
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes of obesity-related hormones indicators: Adiponectin, Leptin	obesity-related hormones indicators were measured in study baseline and 12 week	Baseline and 12 week
Secondary	Changes of energy expenditure Indicators: Uncoupling protein-1(UCP-1), Peroxisome proliferator-activated receptor gamma coactivator-1 a(PGC-1 a)	energy expenditure Indicators were measured in study baseline and 12 week	Baseline and 12 week