NCT04023864Unknown不适用
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
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes of body fat mass
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of Platycodon grandiflorus extract(GCWB107) on decrease of body fat.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes of body fat mass
时间窗: 0 week and 12 week
Body fat mass was measured in study baseline and 12 week.
次要结局
- Changes of fat free mass(0 week and 12 week)
- Changes of Anthropometric indicators(Screening, 0 week, and 12 week)
- Changes of indicator of lipid metabolism(0 week and 12 week)
- Changes of Obesity-related hormone index(0 week and 12 week)
- Changes of percent body fat(0 week and 12 week)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital
研究点 (2)
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