Effects of a Reduction of Sweetened Beverages Consumption in Overweight High Consumers on Cardiometabolic Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- changes in intrahepatic fat concentration
研究概览
简要总结
The study will enroll 68 overweight male and female subjects with a high (> 2 3dl-can soda/day) consumption of sweetened beverage per day. After a run-in period of 4 weeks, subjects will be randomized to either a 12-week intervention arm in which sweetened beverages will be replaced by artificially sweetened, calorie-free beverages, or to a control arm. The following measurements will be performed at the end of the run-in period and at the end of the intervention period
- intrahepatic fat concentration
- visceral fat volume
- changes in day-long metabolic profile from baseline(plasma glucose, insulin, and triglyceride concentrations)
- changes in food intake and daily energy, carbohydrate and sugars intake from baseline
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gender male or female
- •body mass index (BMI) > 27 kg/m2 consumption of > 2 3dl-can regular soda/day
- •low to moderate physical activity (< 60 min walking/day; < 3 exercise session/week
排除标准
- •diabetes mellitus
- •liver, kidney or heart disease
- •any current drug treatment
- •contra-indications to MR examination (pacemaker, foreign bodies,etc)
- •pregnancy or planned pregnancy
- •active weight gain or weight loss (weight change > 4 kg in the past 12 months)
- •consumption of drugs or illicit substances
- •consumption of more than 10g alcohol/day
- •vegetarians or subjects on special diets
研究组 & 干预措施
artificially sweetened beverages
subjects will be required to consume only artificially-sweetened sodas, water, tea or coffee
干预措施: artificially sweetened sodas (Other)
regular sodas
subjects will continue their usual consumption of sweetened sodas
结局指标
主要结局
changes in intrahepatic fat concentration
时间窗: at the end of run-in and after 12 weeks intervention/control
intrahepatic fat content measured by 1H-MRS
次要结局
- changes in food intake from baseline(at the end of the run-in period and after 6, and 12 weeks of intervention/control)
- changes in visceral fat volume(at the end of run-in and after 12 weeks of intervention/control)
- changes in day-long metabolic profile(at the end of run-in and after 12 weeks of intervention/control)
研究者
Luc Tappy, MD
professor of physiology
University of Lausanne