Effect of a Meal Replacement on Weight Loss Obesity Patients With Metabolic Syndrome : A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Participants with weight loss unit in kilograms
研究概览
简要总结
The purpose of this study is to determine whether meal replacement, SlimWell ®, is effective in the treatment of obesity patients with metabolic syndrome.
详细描述
The participants are divided into two groups: intervention group and control group. In the intervention group, the participants receive a meal replacement plus life style modification. In the control group, the participants receive only life style modification.
Sample size calculation is 69 participants per group. Primary outcome is to compare the weight loss between the intervention group and control group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index more than or equal to 25 kg/m2
- •Patients with metabolic syndrome
- •Patients who are on anti-hypertensive drugs, oral hypoglycemic drugs and lipid lowering drugs.
排除标准
- •Uncontrolled diabetes patients
- •Patients with gastrointestinal abnormalities
- •Patients with cardiovascular diseases
- •Patients with hematologic disorders
- •Patients with Glomerular filtration rate less than 60 ml/min/1.73m2
- •Patients with drug or alcohol abuse
- •Pregnancy and lactation
研究组 & 干预措施
meal replacement group
the participants receive a meal replacement plus life style modification
干预措施: meal replacement group (Dietary Supplement)
meal replacement group
the participants receive a meal replacement plus life style modification
干预措施: control group (Behavioral)
control group
the participants receive life style modification only.
干预措施: control group (Behavioral)
结局指标
主要结局
Participants with weight loss unit in kilograms
时间窗: 3 months
Change from baseline body weight at 3 months
次要结局
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study meal replacement, Graded According to NCI CTCAE Version 3.0(3 months)
- Participants with waist circumference change in centimeters(3 months)
- Participants with triglyceride change in mg/dl.(3 months)