Sugar-sweetened beverages and cardiovascular disease risk: an RCT

描述(由申请人提供)：含糖饮料(SSB)的消费与肥胖有关，而且与体重无关，也与糖尿病和心血管疾病的风险有关。随着公众对这些潜在有害影响的认识不断提高，人工加糖饮料(ASB)的消费量大幅增加。这些低卡路里产品在市场上被称为“节食”，暗示它们有助于减肥和改善健康。然而，没有关于ASB和体重或任何其他健康后果的长期实验研究。最近的几项前瞻性观察研究将ASB的摄入与代谢综合征、2型糖尿病和肥胖症的风险增加联系在一起。在拟议的临床试验中，270名习惯食用SSB的年轻人将被随机分配到三组中的一组：1)继续摄入习惯性水平的SSB；2)用ASB代替SSB；或3)用无糖饮料代替SSB。每一组都将在一年内收到目标饮料的送货上门服务，使用的方法是在之前成功工作的基础上进行。将认真注意确保处理的保真度、处理强度的等效性和避免实验混杂。主要的研究终点将是血清甘油三酯与高密度脂蛋白-胆固醇浓度的比率。次要终点将包括其他心血管疾病风险因素、体重、饮食质量和口味偏好的变化。 与公共健康相关：人工加糖饮料(ASB)提出了独特而重要的公共卫生问题，原因有三：1)在过去20年里，它们在美国的消费量呈指数级增长；2)习惯饮用这些产品的人通常比那些限制人工甜味剂摄入量只吃固体食物的人摄入更多的人工甜味剂；3)由于ASB的液体形式，ASB可能具有独特的生物和行为影响。然而，没有关于ASB和任何健康结果的长期对照试验，留下了至关重要的公共卫生问题没有得到回答。本研究旨在填补这一关键知识空白，通过大规模随机对照试验，不仅将ASB的效果与含糖饮料进行比较，还将其与无糖饮料进行比较。

DESCRIPTION (provided by applicant): Consumption of sugar sweetened beverages (SSB) has been linked to obesity and, independent of body weight, risk for diabetes and cardiovascular disease. With rising public health awareness of these potential adverse effects, consumption of artificially sweetened beverages (ASB) has increased dramatically. These low-calorie products are marketed as "diet," with the implication that they promote weight loss and improved health. However, there are no long term experimental studies of ASB and body weight or any other health outcome. Several recent prospective observational studies have linked intake of ASB to increased risk of the metabolic syndrome, type 2 diabetes, and obesity. In the proposed clinical trial, 270 young adults who habitually consume SSB will be randomly assigned to one of three groups: 1) to continue consuming habitual levels of SSB; 2) to substitute ASB for SSB; or 3) to substitute unsweetened beverages for SSB. Each group will receive home delivery of the targeted beverage for 1 year, using methods that build upon previous successful work. Careful attention will be given to assuring treatment fidelity, equivalence of treatment intensity, and avoidance of experimental confounders. The primary study endpoint will be the ratio of serum triglyceride to HDL-cholesterol concentrations. Secondary endpoints will include changes in other cardiovascular disease risk factors, body weight, dietary quality, and taste preferences. PUBLIC HEALTH RELEVANCE: Artificially sweetened beverages (ASB) raise unique and important public health questions for three reasons: 1) their consumption has increased exponentially in the US in the last 2 decades; 2) habitual drinkers of these products typically consume much more artificial sweetener than those who limit artificial sweetener intake to solid foods; and 3) ASB may have unique biological and behavioral effects, by virtue of their liquid form. However, there are no long-term controlled trials of ASB and any health outcome, leaving critically important public health questions unanswered. The present study aims to fill this critical knowledge gap, by comparing the effects of ASB, not just to sugar-sweetened beverages, but also to unsweetened beverages in a large- scale randomized controlled trial.