Double Blind, Randomized Controlled Study to Evaluate the Efficacy and Safety of Extract of Gelidium Elegans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- change in visceral, subcutaneous, total fat area and ratio of visceral and subcutaneous fat area will be combined to report by Fat CT after 12-week treatment
研究概览
简要总结
Extract of Gelidium elegans inhibits lipid differentiation, accumulation, and synthesis in vitro and in vivo. It has also anti-obesity effect by inhibiting weight gain and decreasing body fat. In a preliminary study of obese adults aged 20 years or older, the extracts of Gelidium elegans showed a tendency to decrease in body fat and visceral fat, and to increase lean body mass. Based on these results, we tried to confirm the effect of body weight and body fat reduction of Gelidium elegans extract in overweight and obese people.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 19 and 50
- •BMI is at or greater than 23 and less than 30 kg/m^2
排除标准
- •uncontrolled hypertension
- •uncontrolled diabetes
- •current serious cerebrovascular and cardiovascular disease
研究组 & 干预措施
Test group
taken 3 tablets of Gelidium elegans extract (1000 mg/day) once a day for 12 weeks
干预措施: Exract of Gelidium elegans (Dietary Supplement)
Control group
taken 3 tablets of placebo once a day for 12 weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
change in visceral, subcutaneous, total fat area and ratio of visceral and subcutaneous fat area will be combined to report by Fat CT after 12-week treatment
时间窗: 12 week
change in body fat mass by DEXA after 12-week treatment
时间窗: 12 week
次要结局
- change in body weight and body fat mass will be combined to report by Bio-impedance(12 week)
- change in laboratory test result of fasting insulin(12 week)
- change in ratio of waist and hip circumference(12 week)
- body mass index(12 week)
- change in lean body mass by DEXA(12 week)
- change in waist circumference(12 week)
- change in laboratory test result of CRP(12 week)
- change in HOMA-beta(12 week)
- change in hip circumference(12 week)
- change in laboratory test result of total cholesterol, HDL, LDL and triglyceride will be combined to report as lipid profile(12 week)
- change in HOMA-IR(12 week)