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

A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Platycodon Grandiflorus Extract(GCWB107) on Decrease of Body Fat

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

Study Overview

• Status: Unknown
• Conditions: Body Fat
• Intervention / Treatment: Dietary supplement: Platycodon Grandiflorus Extract(GCWB107); Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Once-daily, once a tablet, after meals, for 12 week
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; Placebo for 12 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of body fat mass	Body fat mass was measured in study baseline and 12 week.	0 week and 12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 %.	0 week and 12 week
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.	0 week and 12 week
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.	Screening, 0 week, and 12 week
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.	0 week and 12 week
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.	0 week and 12 week

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2018
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 28, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Body Fat; Platycodon Grandiflorus Extract
• Other Study ID Numbers: GCWB-BF-PG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No