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

Chonbuk National University

Status: Unknown

Conditions: Obesity

Treatments: Dietary Supplement: Soybean Germ Extract; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03826212

NOVA-BF-SBG

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Soybean Germ Extract

Experimental group

Description:

Soybean Germ Extract 1,600 mg/day for 12 weeks.

Treatment:

Dietary Supplement: Soybean Germ Extract

Placebo

Placebo Comparator group

Description:

Placebo 1,600 mg/day for 12 weeks.

Treatment:

Dietary Supplement: Placebo