NCT03826212

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 3, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

January 23, 2019

Last Update Submit

July 23, 2019

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Changes of body fat mass

    Body fat mass was measured in study baseline and 12 week

    Baseline and 12 week

Secondary Outcomes (9)

  • Changes of percent body fat

    Baseline and 12 week

  • Changes of fat free mass

    Baseline and 12 week

  • Changes of Anthropometric indicate: body weight

    Screening, baseline and 12 week

  • Changes of Anthropometric indicate: body mass index

    Screening, baseline and 12 week

  • Changes of Anthropometric indices: waist circumference, hip circumference

    Screening, baseline and 12 week

  • +4 more secondary outcomes

Study Arms (2)

Soybean Germ Extract

EXPERIMENTAL

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

Dietary Supplement: Soybean Germ Extract

Placebo

PLACEBO COMPARATOR

Placebo 1,600 mg/day for 12 weeks.

Dietary Supplement: Placebo

Interventions

Soybean Germ ExtractDIETARY_SUPPLEMENT

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

Soybean Germ Extract
PlaceboDIETARY_SUPPLEMENT

Placebo 1,600 mg/day for 12 weeks.

Placebo

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

82-63-259-3040soowan@jbnu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

First Submitted

January 23, 2019

First Posted

February 1, 2019

Study Start

June 3, 2019

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

July 24, 2019

Record last verified: 2019-07

Locations

KR(1)