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

人工甜味饮料对成人 2 型糖尿病患者糖尿病控制的影响

• 批准号: 10404994
• 负责人: Andrew Owen Odegaard
• 金额: $ 56.77万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-15 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10404994
• 关键词: Address; Adult; Artificial Sweeteners; Basic Science; Behavior; Beverages; Body Weight decreased; Calories; Cardiovascular Diseases; Caring; Categories; Chronic Disease; Clinical; Clinical Research; Complement; Consumption; Data; Desire for food; Diabetes Mellitus; Diet; Dietary intake; Dietetics; Glycosylated Hemoglobin; Glycosylated hemoglobin A; Health; Hormones; Hour; Intake; Intervention; Knowledge; Link; Measures; Metabolic; Metabolic syndrome; Non-Insulin-Dependent Diabetes Mellitus; Nutrient; Obesity; Obesity Epidemic; Outcome; Patients; Persons; Play; Population; Population Research; Positioning Attribute; Primary Prevention; Public Health; Publications; Randomized; Randomized Clinical Trials; Recommendation; Renal function; Reporting; Research; Risk; Risk Factors; Role; Running; Satiation; Secondary Prevention; Source; Taste preferences; Testing; Twin Multiple Birth; Water; Water consumption; arm; cardiometabolic risk; clinical risk; clinically significant; diabetes control; dietary; disorder risk; evidence base; experience; food environment; glycemic control; gut microbiome; improved; interest; microbiome composition; pilot trial; preference; primary outcome; randomized trial; recruit; scientific organization; sugar; sweet taste perception; sweetened beverage

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.

项目概要 添加人工甜味剂（AS）的减肥饮料在食品中占据着独特的类别 环境，因为它们是强烈甜味的来源，不含热量或营养。减肥饮料是 在美国饮食中，AS 摄入量的最大贡献者是无糖饮料的消费量 过去 30 多年来，随着肥胖和 2 型糖尿病的双重流行，这一数字不断增加。一个 大量的基础、临床和人口研究表明，无糖饮料与 肥胖、肾功能下降以及代谢综合征、2 型糖尿病和糖尿病的风险增加 心血管疾病。其他正在进行的研究表明无糖饮料和甜味剂 它们可能会改变肠道激素、肠道微生物组、口味偏好、饱腹感和总体饮食摄入量，因此 提供可能改变疾病风险的合理机制。这些初步报告以及相关 夸张的媒体报道，激发了科学界和公众对减肥饮料可能发挥的作用的兴趣 玩得健康。尽管知识框架正在萌芽，但证据基础在很大程度上并未得到充分的了解。 随机临床试验测试无糖饮料的摄入是否影响临床风险的衡量标准。 此外，该主题的一个核心问题是缺乏针对患有以下疾病的人群的研究： 糖尿病可能是饮食饮料摄入量最重要的人群。糖尿病患者 是无糖饮料的最大消费者，倾向于将其作为膳食来源的替代品 糖，尤其是代替含糖饮料。这种行为得到了饮食和 科学组织和减肥饮料被宣传为更好健康的代名词，适合 体重减轻，从而有利于糖尿病的控制。潜在的公共卫生问题是 很少有数据支持或反驳患有习惯性饮食饮料的人的益处或危害 糖尿病。为了开始解决这一重要的科学差距，我们建议测试无糖饮料的效果 在随机、两组中，自由生活的 2 型糖尿病成人患者的糖尿病控制参数摄入量 平行试验，磨合期为 2 周，积极干预期为 12 周。我们将招募240名 经常饮用商业减肥饮料的 2 型糖尿病患者，并将他们随机分组 接受并饮用： 1) 选择的商业减肥饮料（每日 3 份或 24 盎司）；或 2) 精选无味瓶装水（气泡水或原味水）（每日 3 份或 24 盎司）。主要结果将是 糖化血红蛋白 (HbA1c) 是临床糖尿病控制的核心指标，我们还将测量 心脏代谢风险和肾功能。此外，我们将测量饮食的合理机制 通过评估无糖饮料摄入量对功能成分的影响，饮料摄入量可能会改变风险 肠道微生物组以及通常的饮食摄入量、食欲和口味偏好。