Sugar-sweetened beverages and cardiovascular disease risk: an RCT

含糖饮料和心血管疾病风险：随机对照试验

• 批准号: 8128446
• 负责人: DAVID S LUDWIG
• 金额: $ 77.5万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-14 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8128446
• 关键词: Adverse effects; Alanine Transaminase; Animals; Artificial Sweeteners; Attention; Awareness; Behavioral; Beverages; Biological; Blood Pressure; Body Weight; Body Weight decreased; Body fat; C-reactive protein; Cardiovascular Diseases; Cell physiology; Clinical Trials; Consumption; Descriptor; Development; Diet; Dietary Fiber; Dual-Energy X-Ray Absorptiometry; Effectiveness; Fabaceae; Fibrinogen; Food; Health; Health Benefit; High Density Lipoprotein Cholesterol; Home environment; Hour; Individual; Intake; Interview; Knowledge; LDL Cholesterol Lipoproteins; Left; Link; Liquid substance; Marketing; Measures; Metabolic syndrome; Methods; Micronutrients; Mineral Waters; Non-Insulin-Dependent Diabetes Mellitus; OGTT; Obesity; Observational Study; Outcome; Plasminogen Activator Inhibitor 1; Public Health; Randomized; Randomized Controlled Trials; Risk; Risk Factors; Sampling; Sensory; Serum; Solid; Solutions; Staging; Taste Perception; Tea; Testing; Triglycerides; Uric Acid; Urine; Water; Weight Gain; Work; base; cardiovascular disorder risk; control trial; diabetes risk; fruits and vegetables; hedonic; improved; insulin sensitivity; preference; prospective; public health relevance; research study; response; sugar; sweet taste perception; sweetened beverage; targeted delivery; waist circumference; young adult

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.

描述（由申请人提供）：含糖饮料（SSB）的消费与肥胖有关，并且与体重无关，与糖尿病和心血管疾病的风险有关。随着公众对这些潜在不利影响的认识不断提高，人工甜味剂饮料 (ASB) 的消费量急剧增加。这些低热量产品被称为“减肥产品”，暗示它们可以促进减肥和改善健康。然而，目前还没有关于 ASB 和体重或任何其他健康结果的长期实验研究。最近的几项前瞻性观察研究表明，摄入 ASB 与代谢综合征、2 型糖尿病和肥胖的风险增加有关。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之一：1）继续食用习惯水平的 SSB； 2）用ASB替代SSB；或3）用不加糖的饮料代替SSB。每个小组将使用以前成功工作的方法，在一年内接受目标饮料的送货上门服务。将仔细注意确保治疗保真度、治疗强度的等效性以及避免实验混杂因素。主要研究终点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危险因素、体重、饮食质量和口味偏好的变化。 公共健康相关性：人工甜味剂饮料 (ASB) 提出了独特而重要的公共健康问题，原因有以下三个：1) 过去 20 年来，美国的消费量呈指数级增长； 2) 经常饮用这些产品的人通常比那些限制摄入固体食物的人造甜味剂的人消耗更多的人造甜味剂； 3) 由于其液体形式，ASB 可能具有独特的生物学和行为效应。然而，目前还没有针对 ASB 和任何健康结果的长期对照试验，因此至关重要的公共卫生问题尚未得到解答。本研究旨在通过大规模随机对照试验比较 ASB 的效果，不仅与含糖饮料，而且与不加糖饮料比较，从而填补这一关键的知识空白。