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

NCT ID: NCT03826212

Last Updated: 2019-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-03

Study Completion Date

2020-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Soybean Germ Extract

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

Group Type EXPERIMENTAL

Soybean Germ Extract

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Placebo 1,600 mg/day for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo 1,600 mg/day for 12 weeks.

Interventions

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Soybean Germ Extract

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo 1,600 mg/day for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Principal Investigator, Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Soo Wan Chae, Ph.D., M.D.

Role: CONTACT

82-63-259-3040

Facility Contacts

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Soo-Wan Chae, MD., PhD

Role: primary

82-63-259-3040

Other Identifiers

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NOVA-BF-SBG

Identifier Type: -

Identifier Source: org_study_id

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