Effect of Artificially Sweetened Beverages on Diabetes Control in Adults with Type 2 Diabetes

项目总结 添加人工甜味剂(AS)的减肥饮料在食品中占有独特的类别 因为它们是没有卡路里或营养的强烈甜味的来源。减肥饮料是 在美国饮食中，砷摄入量的最大贡献者，以及减肥饮料的消费 在过去30多年里，随着肥胖症和2型糖尿病的双重流行，这一数字增加了。一个 新兴的基础、临床和人群研究表明，减肥饮料与 肥胖、肾功能下降和代谢综合征、2型糖尿病风险增加，以及 心血管疾病。其他正在开发的研究表明，减肥饮料和甜味剂 它们可能会改变肠道激素、肠道微生物群、口味偏好、饱腹感和总的饮食摄入量，因此 提供看似合理的机制，可借此改变疾病风险。这些初始报告以及相关 媒体夸张的报道，引发了科学和公众对减肥饮料可能 在健康状态下打球。尽管这个萌芽中的知识框架，证据基础在很大程度上是不知情的 测试减肥饮料摄入量是否影响临床风险测量的随机临床试验。 此外，这一主题的一个核心问题是缺乏针对人口的研究 糖尿病，可能是饮食饮料摄入量方面最重要的人群。糖尿病患者 是减肥饮料的最大消费者，倾向于将其作为饮食来源的替代品 糖，尤其是用来代替加糖饮料。这一行为已经得到了节食和 科学组织，减肥饮料被推销为更好健康的代名词，适合 减肥，从而有利于糖尿病的控制。潜在的公共卫生问题是， 很少有数据支持或驳斥患有糖尿病的人习惯饮食饮料的好处或坏处 糖尿病。为了开始解决这一重要的科学鸿沟，我们建议测试减肥饮料的效果 随机双臂摄入量对自由生活的2型糖尿病成人患者糖尿病控制参数的影响 平行试验，磨合期2周，积极干预期12周。我们将招聘240人 2型糖尿病患者，他们通常是商业减肥饮料的消费者，并随机选择 接受和消费：1)选择商业减肥饮料(3份或24盎司)。每日)；或2) 选择不加调味的瓶装水(起泡或原味)(3份或24盎司。每日)。主要结果将是 糖化血红蛋白(HbA1c)是临床糖尿病控制的中心指标，我们还将测量 心脏代谢风险和肾功能。此外，我们将测量合理的机制，使饮食 饮料摄入量可能通过评估节食饮料摄入量对心脏功能成分的影响来改变风险 肠道微生物群以及通常的饮食摄入量、食欲和口味偏好。

PROJECT SUMMARY Diet beverages sweetened with artificial sweeteners (AS) occupy a unique category in the food environment as they are a source of intensely sweet taste with no calories or nutrients. Diet beverages are the single largest contributor to AS intake in the U.S. diet, and consumption of diet beverages has significantly increased over the past 30 plus years in concert with the twin epidemics of obesity and type 2 diabetes. A burgeoning body of basic, clinical, and population research suggests that diet beverages are linked with obesity, decline in kidney function, and increased risk of metabolic syndrome, type 2 diabetes, and cardiovascular disease. Other developing research has suggested diet beverages and the AS that sweeten them may alter gut hormones, the gut microbiome, taste preferences, satiety, and overall dietary intake, thus providing plausible mechanisms whereby disease risk may be altered. These initial reports, and related hyperbolic media coverage, have sparked both scientific and public interest in the role that diet beverages may play in health. Despite this budding framework of knowledge, the evidence base is largely uninformed by randomized clinical trials testing whether intake of diet beverages impacts measures of clinical risk. Furthermore, an issue central to this topic is the lack of research addressing the population with diabetes, perhaps the most important population with respect to diet beverage intake. People with diabetes are the highest consumers of diet beverages, tending to consume them as a replacement for dietary sources of sugar, especially in place of sugar-sweetened beverages. This behavior has been endorsed by dietetic and scientific organizations, and diet beverages are marketed as being synonymous with better health, suitable for weight loss, and thus advantageous for diabetes control. The underlying public health concern is that there are few data to support or refute the benefit or harm of habitual diet beverage consumption by people with diabetes. To begin addressing this important scientific gap we propose to test the effect of diet beverage intake on diabetes control parameters in free-living adults with type 2 diabetes in a randomized, two arm parallel trial with a run-in period of 2-weeks and an active intervention period of 12-weeks. We will recruit 240 patients with type 2 diabetes who are usual consumers of commercial diet beverages and randomize them to receive and consume either: 1) A commercial diet beverage of choice (3 servings or 24 oz. daily); or 2) Unflavored bottled water of choice (sparkling or plain) (3 servings or 24 oz. daily). The primary outcome will be a central measure of clinical diabetes control in glycated hemoglobin (HbA1c), and we will also measure cardiometabolic risk and kidney function. Additionally, we will measure plausible mechanisms whereby diet beverage intake may alter risk by assessing the effect of diet beverage intake on the functional composition of the gut microbiome as well as usual dietary intake, appetite, and taste preferences.