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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platycodon Grandiflorus Extract(GCWB107) group | Experimental | Once-daily, once a tablet, after meals (900 mg/day, 571 mg/day as a Platycodon Grandiflorus Extract(GCWB107)) |
|
| Placebo group | Placebo Comparator | Once-daily, once a tablet, after meals (900 mg/day, 0 mg/day as a Platycodon Grandiflorus Extract(GCWB107)) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platycodon Grandiflorus Extract(GCWB107) | Dietary Supplement | Once-daily, once a tablet, after meals, for 12 week |
|
| 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 |
| 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 |
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Inclusion 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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Wan Chae, Ph.D., M.D. | Contact | 82-63-259-3040 | soowan@jbnu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods Chonbuk National University Hospital | Recruiting | Jeonju | Jeollabuk-do | 54907 | South Korea |
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| Placebo | Dietary Supplement | Placebo for 12 week |
|
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 |