Conjugated Linoleic Acid and Body Fat Mass in Obese Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in lean body mass at 12 weeks
研究概览
简要总结
The purpose of this clinical trial is to examine the effects of a low and high dose of conjugated linoleic acid supplement on body composition in obese humans. Individuals with a body mass index between 30 and 35kg/m2 are randomized to receive either placebo, 3.2gCLA, or 6.4g CLA daily for twelve weeks. Changes in body composition, weight, and clinical laboratory values are compared between the three groups.
详细描述
Sixty healthy obese adult volunteers will be enrolled and randomized into either: 1) placebo, 2) 3.2 g CLA, or 3) 6.4 g CLA groups and supplemented for 12 weeks. Body fat mass (BFM) and lean body mass will be determined by DEXA at baseline and twelve weeks during the intervention. In addition, indirect calorimetry will be performed at baseline and twelve weeks to measure changes in energy expenditure. The effect of CLA supplementation on weight, waist and hip measurements, and BMI will also be determined at 12 weeks. Plasma CLA and pill counts will be measured as an indication of compliance. Several blood parameters will be monitored throughout the study, and five random 24-hour recall surveys will be used to monitor dietary intake of CLA-rich foods, energy, micronutrients and antioxidants.
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
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 30 and 35 kg/m2
排除标准
- •history of chronic disease
- •food allergies or intolerances
- •drug therapy for diagnosed disease or lipid-lowering
- •use of weight-lowering medication or diet
- •use of tobacco products
- •current or planned pregnancy
- •use of CLA supplement in previous 3 months
- •current substance abuse
- •abnormal clinical laboratory values
结局指标
主要结局
Change in lean body mass at 12 weeks
Change in body mass index at 12 weeks
Change in body weight at 12 weeks
Change in energy expenditure at 12 weeks
Change in body fat mass at 12 weeks
次要结局
- Change in lipid profile at 6 weeks and 12 weeks
- Change in clinical laboratory values at 6 weeks and 12 weeks (safety)