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

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ClinicalTrials.gov Identifier: NCT03826212
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

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

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Soybean Germ Extract Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : February 28, 2020

Arm Intervention/treatment
Experimental: Soybean Germ Extract
Soybean Germ Extract 1,600 mg/day for 12 weeks.
Dietary Supplement: Soybean Germ Extract
Soybean Germ Extract 1,600 mg/day for 12 weeks.

Placebo Comparator: Placebo
Placebo 1,600 mg/day for 12 weeks.
Dietary Supplement: Placebo
Placebo 1,600 mg/day for 12 weeks.




Primary Outcome Measures :
  1. Changes of body fat mass [ Time Frame: Baseline and 12 week ]
    Body fat mass was measured in study baseline and 12 week


Secondary Outcome Measures :
  1. Changes of percent body fat [ Time Frame: Baseline and 12 week ]
    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 %.

  2. Changes of fat free mass [ Time Frame: Baseline and 12 week ]
    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.

  3. Changes of Anthropometric indicate: body weight [ Time Frame: Screening, baseline and 12 week ]
    Anthropometric indices were measured in study screening, baseline and 12 week. Body weight in kg.

  4. Changes of Anthropometric indicate: body mass index [ Time Frame: Screening, baseline and 12 week ]
    Anthropometric indices were measured in study screening, baseline and 12 week. Weight/height^2 will be report body mass index in kg/m^2.

  5. Changes of Anthropometric indices: waist circumference, hip circumference [ Time Frame: Screening, baseline and 12 week ]
    Anthropometric indices were measured in study screening, baseline and 12 week. Waist circumference, hip circumference in cm.

  6. Changes of Anthropometric indicate: waist -hip circumference ratio [ Time Frame: Screening, baseline and 12 week ]
    Anthropometric indices were measured in study screening, baseline and 12 week. Waist circumference/hip circumference will be report waist -hip circumference ratio.

  7. Changes of lipid metabolism indicators: Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol [ Time Frame: Baseline and 12 week ]
    Lipid metabolism indicators(mg/dL) were measured in study baseline and 12 week.

  8. Changes of obesity-related hormones indicators: Adiponectin, Leptin [ Time Frame: Baseline and 12 week ]
    obesity-related hormones indicators were measured in study baseline and 12 week

  9. Changes of energy expenditure Indicators: Uncoupling protein-1(UCP-1), Peroxisome proliferator-activated receptor gamma coactivator-1 α(PGC-1 α) [ Time Frame: Baseline and 12 week ]
    energy expenditure Indicators were measured in study baseline and 12 week



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826212


Contacts
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Contact: Soo Wan Chae, Ph.D., M.D. 82-63-259-3040 soowan@jbnu.ac.kr

Locations
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Korea, Republic of
Clinical Trial Center for Functional Foods Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 54907
Contact: Soo-Wan Chae, MD., PhD    82-63-259-3040    swchae@jbctc.org   
Sponsors and Collaborators
Chonbuk National University Hospital

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Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT03826212     History of Changes
Other Study ID Numbers: NOVA-BF-SBG
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No