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

Body Fat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04023864
• Other study ID #: GCWB-BF-PG
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: November 2019
• Source: Chonbuk National University Hospital
• Contact: Soo Wan Chae, Ph.D., M.D.
• Phone: 82-63-259-3040
• Email: soowan[@]jbnu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Fat

Intervention

Dietary Supplement:
• Platycodon Grandiflorus Extract(GCWB107)
Once-daily, once a tablet, after meals, for 12 week
• Placebo
Placebo for 12 week

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of body fat mass	Body fat mass was measured in study baseline and 12 week.	0 week and 12 week
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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