Health effects of substituting sugar-sweetened beverages with non-caloric beverages in adults with overweight and obesity

用无热量饮料替代含糖饮料对超重和肥胖成人的健康影响

• 批准号: 10206135
• 负责人: Deirdre Kay Tobias
• 金额: $ 78.07万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10206135
• 关键词: Address; Adherence; Adult; Age; Artificial Sweeteners; Aspartame; Awareness; Behavior; Beverages; Blinded; Blood; Blood Pressure; Body Weight; Body Weight decreased; Body Weights and Measures; Body mass index; Calories; Cardiometabolic Disease; Cardiovascular Diseases; Cellular Phone; Clinic Visits; Clinical; Clinical Trials; Clinical Trials Design; Collection; Consumption; Control Groups; Data Collection; Desire for food; Diet; Dietary Intervention; Effectiveness; Enrollment; Ensure; Epidemiology; Etiology; Feasibility Studies; Feces; Financial compensation; Frequencies; Future; Health; Heterogeneity; High Density Lipoproteins; Home; Inflammation; Infrastructure; Intake; Intention; Interleukin-6; Intervention; Intervention Trial; Knowledge; Label; Life Style; Link; Lipids; Marketing; Measures; Metabolism; Methods; Modeling; Modernization; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; Nutritional; Obesity; Observational Study; Online Systems; Overweight; Participant; Pattern; Persons; Physical activity; Pilot Projects; Population Heterogeneity; Preventive Medicine; Public Health; Questionnaires; Randomized; Randomized Controlled Trials; Recommendation; Reporting; Research Personnel; Residual state; Sampling; Source; Sugar Substitute; Taste preferences; Taxation; Testing; United States National Institutes of Health; Urine; Visit; Water; Weight Gain; arm; base; cardiometabolism; design; diabetes risk; dietary; dietary guidelines; dieting; digital; disorder risk; effectiveness evaluation; energy balance; epidemiology study; fecal microbiome; feeding; follow-up; improved; innovation; insulin sensitivity; lifestyle factors; mortality; novel; obesity prevention; obesity risk; primary outcome; public health intervention; recruit; secondary analysis; sugar; sweetened beverage; tool; treatment group; trial design; waist circumference; wireless fidelity

PROJECT SUMMARY/ABSTRACT This is a new application proposing to conduct the SUBstituting with Preferred OPtions (SUB-POP) trial, a parallel-arm RCT to test the effects of substituting SSBs with non-caloric options on body weight and markers of T2D and cardiometabolic health. Eligible adult participants will be randomized to 1 of 4 beverage groups (N=135 per group) at the baseline in-person visit and all will receive at-home monthly deliveries of beverages via Amazon for 6 months. In-person clinic visits will be conducted at baseline, 6, and 12 months. After the 6 months of assigned beverage substitution and delivery, all participants will be instructed to substitute SSBs with water only for a final 6 month observational period. In-person clinic visits will collect technician-measured anthropometrics, blood pressure, biospecimen samples (blood, urine, stool [subset n=50 per group]), and questionnaires (physical activity, beverage frequency), and taste preference test. The SUB-POP app-based assessments and online diet recall will ascertain repeated measures of beverage adherence, diet, physical activity, and appetite in the interim, every 3 months. A subset (n=60 per group) will receive at home Wi-Fi digital scales to measure body weight approximately daily for novel energy balance and caloric compensation modeling. Our proposal will leverage the many strengths and state-of-the-art clinical trial infrastructure of the Division of Preventive Medicine at BWH. The highly collaborative investigator team is comprised of experts in nutritional and obesity epidemiology, clinical trial design, implementation and analysis, energy balance and weight loss, and interpretation for public health dietary guidelines. SUB-POP is a novel RCT that will enroll adult regular SSB consumers with overweight or obesity to evaluate the effectiveness of substituting SSBs with non-caloric options in a real-world, un-blinded setting. Our trial will leverage modern recruitment methods, achieve ≥30% non-White participants, implement innovative intervention delivery, adherence, and data collection tools, and partition the two most common artificial sweetener types to explore potential heterogeneity. It is unknown whether ASBs, which are largely free of calories and sugar, provide a healthful interim strategy to transition to water among habitual SSB consumers. Thus, by addressing this large gap in our understanding of how to address a highly prevalent and concerning dietary exposure, we will inform dietary guidelines and clinical recommendations for the prevention of obesity, T2D, and cardiometabolic disease risks.

项目摘要/摘要 这是一项新的申请建议，用于通过首选选项（Sub-Pop）试验进行替换，一个 并行臂RCT测试具有非平均选择对体重和标记的替代SSB的影响 T2D和心脏代谢健康。合格的成年参与者将被随机分为4个卧室组中的1个 （每组n = 135），在基线面对面访问，所有人都将每月收到床单 通过亚马逊持续6个月。面对面的诊所就诊将在基线，6和12个月进行。 6之后 分配的床位替代和交货月，将指示所有参与者替代SSB 仅在最后6个月的观察期间使用水。面对面的诊所就诊将收集技术测量 人类学，血压，生物测量样品（血液，尿液，粪便[子集n = 50 n = 50]）和 问卷（体育锻炼，卧室频率）和口味偏好测试。基于子流行应用程序 评估和在线饮食召回将确定卧室依从性，饮食，身体的重复措施 活动和食欲每3个月。子集（每组n = 60）将在家里接收Wi-Fi 数字尺度以测量大约每天的体重，以实现新颖的能量平衡和热量补偿 造型。我们的建议将利用许多优势和最新的临床试验基础设施 BWH的预防医学司。高度协作的调查员团队已完成专家 营养和肥胖流行病学，临床试验设计，实施和分析，能量平衡和 体重减轻和公共卫生饮食指南的解释。子流行是一种新颖的RCT，可以注册 成人常规的SSB消费者超重或肥胖，以评估用SSB替代SSB的有效性 在现实世界中，非盲目的环境中的非平均选择。我们的审判将利用现代招聘方法， 实现≥30％的非白人参与者，实施创新干预，遵守和数据 收集工具，并分配两种最常见的人造甜味剂类型，以探索潜力 异质性。尚不清楚ASB是否不含卡路里和糖的ASB是否提供健康 习惯性SSB消费者之间过渡到水的临时策略。通过解决这个巨大差距 我们对如何解决高度普遍且与饮食暴露有关的理解，我们将告知饮食 预防肥胖，T2D和心脏代谢疾病风险的指南和临床建议。