Effect of Momordica Charantia Administration on Anthropometric Indicators in Patients With Obesity
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change from baseline body weight (BW) at 12 weeks
研究概览
简要总结
Momordica charantia has shown to exert anti-obesity effects through numerous mechanisms of action described in preclinical studies. Important reductions in body weight and other anthropometric indicators have been reported in clinical trials. However, these beneficial effects of Momordica charantia on obesity have been observed mainly in type 2 diabetes mellitus patients. The purpose of this study is to evaluate the effect of Momordica charantia administration on anthropometric indicators in patients with obesity.
详细描述
A randomized, double-blind, placebo controlled clinical trial is carried out in 24 patients with obesity according to the body mass index.
Patients are assigned to two different arms: one group receives Momordica charantia, 2 capsules with 500 mg twice daily before breakfast and dinner for 12 weeks or placebo, under the same scheme of treatment.
Body weight, body mass index, waist circumference, body fat percentage and other clinical and laboratory parameters are evaluated.
This protocol is approved by a local ethics committee and written informed consent will be obtained from all volunteers.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of obesity type I according to body mass index (IMC: 30.0 - 34.9 kg/m2)
- •Body weight without variations above or under 5% in the last three months before entering the study
- •Fasting plasma glucose: <126 mg/dL
- •Total cholesterol: <240 mg/dL
- •Triglycerides: <400 mg/dL
- •Women in childbearing years must have a contraceptive method
- •Letter of consent and release signed by each patient
排除标准
- •Women with confirmed or suspected pregnancy
- •Women under lactation and/or puerperium
- •Known uncontrolled renal, hepatic, cardiovascular or thyroid disease
- •Physical impossibility for taking pills
- •Known hypersensibility to the Momordica charantia or placebo
结局指标
主要结局
Change from baseline body weight (BW) at 12 weeks
时间窗: 12 weeks
BW is evaluated at baseline and after 12 weeks with an electric bioimpedance digital scale (Model TBF-300 A; Tanita Corporation of America Inc., Arlington Heights, IL)
Change from baseline body mass index (BMI) at 12 weeks
时间窗: 12 weeks
BMI is calculated at baseline and after 12 weeks with the Quetelet index formula
Change from baseline fat mass at 12 weeks
时间窗: 12 weeks
Fat mass is measured at baseline and after 12 weeks with an electric bioimpedance digital scale (Model TBF-300 A; Tanita Corporation of America Inc., Arlington Heights, IL)
Change from baseline waist circumference (WC) at 12 weeks
时间窗: 12 weeks
WC is evaluated at baseline and after 12 weeks with a flexible tape in the midpoint between the lowest rib and the iliac crest
次要结局
- Change from baseline total cholesterol at 12 weeks(12 weeks)
- Change from baseline aspartate aminotransferase (AST) at 12 weeks(12 weeks)
- Change from baseline systolic blood pressure at 12 weeks(12 weeks)
- Change from baseline very low density lipoprotein (VLDL) at 12 weeks(12 weeks)
- Change from baseline uric acid at 12 weeks(12 weeks)
- Change from baseline alanine aminotransferase (ALT) at 12 weeks(12 weeks)
- Change from baseline diastolic blood pressure at 12 weeks(12 weeks)
- Change from baseline triglycerides at 12 weeks(12 weeks)
- Change from baseline creatinine at 12 weeks(12 weeks)
- Change from baseline fasting plasma glucose (FPG) at 12 weeks(12 weeks)
- Change from baseline high density lipoprotein cholesterol (HDL-c) at 12 weeks(12 weeks)
- Change from baseline low density lipoprotein cholesterol (LDL-c) at 12 weeks(12 weeks)
研究者
Marisol Cortez Navarrete
Principal investigator
University of Guadalajara