Effect of Carbonated Soft Drinks on Body Weight, Fat Distribution and Metabolic Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Body Weight (kg)
研究概览
简要总结
Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation leading to obesity development. Although drinks sweetened with aspartame are available the anticipated positive effect of these drinks on obesity development has not been convincing. However, the mechanisms linking drinks intake to obesity are yet to be clarified.
The investigators aim is to investigate the long-term effects of intake of soft drinks, milk and water. The study is a parallel, intervention trial with 80 overweight, healthy volunteers. They will be randomly selected to drink one liter a day of one of the four drinks for six months. The objectives are changes in numerous circulating metabolic risk factors, changes in body weight, anthropometric data and fat distribution (measured by DEXA, MRI and MR-spectroscopy).
The investigators expect to clarify the mechanisms linking drinking habits to obesity development and provide scientifically based nutritional guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 20-50 years;
- •BMI between 28-36 kg/m2;
- •Weight stabile 3 months prior to the study inclusion;
- •Less than 10 hours of weekly exercise
排除标准
- •Allergic to phenylalanine or milk
- •Pregnancy or breast-feeding
结局指标
主要结局
Body Weight (kg)
时间窗: Six months
MR spectroscopy
时间窗: Six months
to assess liver fat and skeletal muscle fat
Dual-energy X-ray absorptiometry (DEXA) scan
时间窗: Six months
to assess total fat mass (kg), lean body mass (kg), and bone mass (kg)
Magnetic resonance imaging
时间窗: Six months
to assess visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAAT)
次要结局
- Fasting plasma PAI-1(Six months)
- fasting serum insulin(Six months)
- Blood pressure(Six months)
- Circulating metabolic parameters: including serum urate(Six months)
- Oral Glucose Tolerance Test (OGTT)(Six months)
- Fasting plasma FFA(Six months)
- fasting plasma glucose(Six months)
- Fasting blood lipids(Six months)
研究者
Maria Maersk Nielsen
MD, PHD
Aarhus University Hospital