Comparison of the Effects of a 12-Week Consumption of Two Carbonated Beverages on Insulin Sensitivity
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
- Matsuda Insulin sensitivity Index
研究概览
简要总结
The purpose of this study is to determine whether consumption of carbonated drinks containing sweeteners affect insulin sensitivity.
详细描述
Sweeteners are natural or synthetic sugar substitutes which provide a sweetness taste to drink and food with few or no additional calories. Sweeteners are widely used in commercialized beverages. Despite some debate, no significant toxicity was demonstrated at a reasonable level of consumption (less than 20 cans per day). However little data is available on the metabolic effects of a regular consumption of beverages containing sweeteners. The objective of the study is to evaluate the effect of a regular consumption (twice a day for 12 weeks) of a carbonated drink with sweeteners, in a normal diet, compared with unsweetened sparkling water on insulin sensitivity in healthy normoweight and overweight subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Healthy male or female
- •Subject taking at least three main meals (breakfast, lunch, dinner)
- •Subject able to understand and sign an informed consent
- •Subject drinking and enjoying soft drinks
- •Subject appreciating sweeteners taste
- •19 kg/m² < BMI< 30 kg/m²
排除标准
- •Any severe or acute illness that may influence the results of the study or may be life-threatening
- •Pregnant or breastfeeding subject
- •Past or present metabolic or digestive diseases, with the exception of a possible appendectomy
- •Diabetes or severe acute illness that may alter blood sugar
- •Treatment that may interfere with glucose homeostasis
- •Past or present kidney disease (renal failure, ... )
- •Local or systemic medication that may change water status, metabolism and feeding behavior
- •Antiplatelet treatment
- •Alcohol consumption ≥ 3-4 glasses / day ( ≥ 21 drinks / week )
- •Sustained physical exercise (more than 4 hours per week)
- •Subject adding sweeteners (tablets or powder) in their diet
- •Subject drinking more than two cans of drinks with sweeteners / day
- •Subject dieting to lose weight
- •Subject unable or unwilling to consume 2 liters of fluid / day
结局指标
主要结局
Matsuda Insulin sensitivity Index
时间窗: Before and after each of the two 12-week intervention period
次要结局
- Insulinogenic Index defined as ∆ insulin 0-30 / ∆ glucose 0-30(Before and after each of the two 12-week intervention period)
- Disposition index defined as Insulin sensitivity x insulinogenic Index(Before and after each of the two 12-week intervention period)
- HOMA-IR Index defined as fasting Glycemia x fasting insulinemia/22.5(Before and after each of the two 12-week intervention period)
- Dietary intake(Before and after each of the two 12-week intervention period)
- Physical activity(Before and after each of the two 12-week intervention period)