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Status unknownNCT04023864Updated Dec 2, 2019

Efficacy and Safety of Platycodon Grandiflorus Extract(GCWB107) on Decrease of Body Fat

An interventional study of Platycodon Grandiflorus Extract(GCWB107) and Placebo in Body Fat, sponsored by Chonbuk National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-02.

Sponsored by Chonbuk National University Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Oct 2018, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study summary

This study was conducted to investigate the effects of daily supplementation of Platycodon grandiflorus extract(GCWB107) on decrease of body fat.

Read the detailed description

This study was a 12-week, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into Platycodon grandiflorus extract(GCWB107) group and a placebo group. It is to evaluate the changes in the displayed evaluation items when taking Platycodon grandiflorus extract(GCWB107) extract once a day, in comparison with taking a placebo.

02

Conditions studied

  • Body Fat

Keywords

  • Platycodon Grandiflorus Extract
  • Body Fat
03

In context

Lead sponsor

Chonbuk National University Hospital is the lead sponsor of 88 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Males and females aged between 19 and 65 years at the screening
  • Participants who were BMI 25\~29.9 kg/m\^2
  • Participants who have fully understood the information provided about the study voluntarily decided to participate and agreed to comply with precautions

Exclusion criteria

Exclusion Criteria:

  • Participants who decrease 10% more of weight within 3 months period to the screening examination
  • Participants taking for products affecting body weight within 4 weeks before the screening examination(i.e., Improvement of body fat Healthy functional food, contraceptive, steroid drug treatment, female hormone drug treatment) (However, participation is possible after a 4-week withdrawal period prior to the first intake day)
  • Participants who drink more than 14 units/week of alcohol intake
  • Patients with a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry system, musculoskeletal system, inflammatory and hematologic
  • Patients with diabetics who are taking oral hypoglycemic agents and insulin (at the screening)
  • Participants with a past history of gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgery (but, excluding simple cecal surgery and hernia surgery) that can affect the absorption of products of the human trial
  • Participants who have a history of clinically significant hypersensitivity to balloon flower and saponin components
  • Participants receiving antipsychotic medication within 2 months prior to the screening examination
  • Participants who were doubtful about drug abuse
  • Participants who have participated in other clinical trials within 3 months prior to the screening examination
  • Participants who have SBP≥180 mmHg and DBP≥110 mmHg
  • Menopause women

  • Participants who show the following relevant results in a Laboratory test

    • Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
    • Serum Creatinine > 2.0 mg/dl
  • Women who are pregnant or breastfeeding
  • Women who may become pregnant and have not used appropriate contraceptives
  • Participants who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Platycodon Grandiflorus Extract(GCWB107) group

    Once-daily, once a tablet, after meals (900 mg/day, 571 mg/day as a Platycodon Grandiflorus Extract(GCWB107))

    Dietary Supplement: Platycodon Grandiflorus Extract(GCWB107)

  • Placebo comparator
    Placebo group

    Once-daily, once a tablet, after meals (900 mg/day, 0 mg/day as a Platycodon Grandiflorus Extract(GCWB107))

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementPlatycodon Grandiflorus Extract(GCWB107)

    Once-daily, once a tablet, after meals, for 12 week

  • Dietary supplementPlacebo

    Placebo for 12 week

06

What researchers measure

Primary outcomes

  1. Changes of body fat mass

    Body fat mass was measured in study baseline and 12 week.

    Time frame: 0 week and 12 week

Secondary outcomes

  1. 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 reported percent body fat in %.

    Time frame: 0 week and 12 week

  2. 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 reported fat free mass in g.

    Time frame: 0 week and 12 week

  3. Changes of Anthropometric indicators

    Anthropometric indicators(i.e., weight, body mass index, waist circumference, hip circumference, waist-hip ratio) were measured in study screening, 0 weeks, and 12 weeks.

    Time frame: Screening, 0 week, and 12 week

  4. Changes of indicator of lipid metabolism

    Indicators of lipid metabolism(i.e., Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol) were measured in the study for 0 weeks and 12 weeks.

    Time frame: 0 week and 12 week

  5. Changes of Obesity-related hormone index

    Obesity-related hormone indexes(i.e., Adiponectin, Leptin)were measured in the study for 0 weeks and 12 weeks.

    Time frame: 0 week and 12 week

07

Study locations

1 of 1 sites recruiting
  • Clinical Trial Center for Functional Foods Chonbuk National University Hospital
    Jeonju, Jeollabuk-do 54907, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04023864
Lead sponsor
Chonbuk National University Hospital
Responsible party
Soo-Wan Chae (Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital) — Principal investigator
First posted
Jul 18, 2019
Start date
Oct 19, 2018
Primary completion
Jun 30, 2020 (estimated)
Completion
Nov 30, 2020 (estimated)
Last update
Dec 2, 2019

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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