Status:
UNKNOWN
Efficacy and Safety of Platycodon Grandiflorus Extract(GCWB107) on Decrease of Body Fat
Lead Sponsor:
Chonbuk National University Hospital
Conditions:
Body Fat
Eligibility:
All Genders
19-65 years
Phase:
NA
Brief Summary
This study was conducted to investigate the effects of daily supplementation of Platycodon grandiflorus extract(GCWB107) on decrease of body fat.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04023864
Start Date
October 19 2018
End Date
November 30 2020
Last Update
December 2 2019
Active Locations (1)
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1
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea, 54907