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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Body Fat

Intervention / Treatment
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* Dietary Supplement: Platycodon Grandiflorus Extract(GCWB107)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platycodon Grandiflorus Extract(GCWB107) group<br>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)<br>* Once-daily, once a tablet, after meals, for 12 week<br>|
| Placebo Comparator: Placebo group<br>Once-daily, once a tablet, after meals (900 mg/day, 0 mg/day as a Platycodon Grandiflorus Extract(GCWB107)) | Dietary Supplement: Placebo<br>* Placebo for 12 week<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platycodon Grandiflorus Extract, Body Fat