Effect of Milk Thistle Derivative Silibinin(A) as a Potential Anti-obesity Agent
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of total body weight loss
研究概览
简要总结
Our preliminary reports have found in silico and in vitro that the milk thistle derivative Silibinin(A) is able to inhibit pancreatic lipase, in a similar way that the classical anti-obesity drug orlistat.
Therefore, the investigators want to carry out the present trial in order to confirm that Silibinin(A) is able to in vivo inhibit pancreatic lipase, which will reduce the fat absorption and therefore will decrease the amount of energy from food intake.
Considering that milk thistle has been extensively studied in humans as liver-protector, the investigators consider that the use of human subjects will be of great interest to accelerate the employment of this compound to improve the effectiveness of dietary treatment in overweight/obese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI > 24,9
- •Voluntarily participate in the study
排除标准
- •significant cognitive impairment
- •psychiatric disorders
- •chronic pharmacological treatment that may affect the effectiveness of the dietary intervention (corticosteroids, thyroid hormones, oral antidiabetic agents or lipid-lowering drugs)
- •chronic disease that may interfere with dietary therapy (cancer, renal or hepatic impairment, chronic gastrointestinal conditions)
- •acute disease episodes during the study
- •subjects who followed a hypocaloric diet at the allocation time or in the 3 months prior to the beginning of the study
- •pregnant women
结局指标
主要结局
Percentage of total body weight loss
时间窗: 3 months
Change in body weight from baseline to the end of study period (3 months).
次要结局
- Body fat percentage(3 months)
- Plasma triglycerides(3 months)
- Body mass index (BMI)(3 months)
- Plasma total cholesterol(3 months)
- Plasma low density level cholesterol (cLDL)(3 months)
- Waist circumference(3 months)
研究者
Juan Jose Hernández Morante
Main researcher at Eating-related disorders research unit
Universidad Católica San Antonio de Murcia