Clinical trial NCT04023864: Efficacy and Safety of Platycodon Grandiflorus Extract(GCWB107) on Decrease of Body Fat
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Body Fat
Keywords: Platycodon Grandiflorus Extract
Body Fat
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 evaluate the changes in the displayed evaluation items when taking Platycodon grandiflorus extract(GCWB107) extract once a day, in comparison with taking a placebo.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of body fat mass
timeFrame: 0 week and 12 week
Secondary outcomes:
measure: Changes of percent body fat
timeFrame: 0 week and 12 week
measure: Changes of fat free mass
timeFrame: 0 week and 12 week
measure: Changes of Anthropometric indicators
timeFrame: Screening, 0 week, and 12 week
measure: Changes of indicator of lipid metabolism
timeFrame: 0 week and 12 week
measure: Changes of Obesity-related hormone index
timeFrame: 0 week and 12 week
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References: