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: 10028809
• 负责人: Deirdre Kay Tobias
• 金额: $ 77.25万
• 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/10028809
• 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; Calories; 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 environment; 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 guidelines; 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.

项目概要/摘要 这是一个新的应用程序，提议进行首选选项替代（SUB-POP）试验， 平行臂随机对照试验，测试用无热量选项替代 SSB 对体重和标记物的影响 符合 T2D 和心脏代谢健康状况的成年参与者将被随机分配到 4 个饮料组中的一组。 （每组 N = 135）在基线亲自访问时，所有人都将每月在家中收到饮料 为期 6 个月的面对面门诊将在基线、6 个月和 6 个月后进行。 在指定的饮料替换和交付的月份内，所有参与者将被指示替换 SSB 仅在最后 6 个月的观察期内用水 亲自到诊所就诊将收集技术人员测量的数据。 人体测量、血压、生物样本（血液、尿液、粪便[每组 n=50]），以及 问卷调查（身体活动、饮料频率）和基于 SUB-POP 应用程序的口味偏好测试。 评估和在线饮食回忆将确定对饮料依从性、饮食、身体状况的重复测量 在此期间，每 3 个月有一个小组（每组 60 人）将在家中接收 Wi-Fi。 数字秤大约每天测量体重，以实现新颖的能量平衡和热量补偿 我们的建议将利用众多优势和最先进的临床试验基础设施。 BWH 预防医学部的高度协作的研究团队由以下领域的专家组成。 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 减肥和公共卫生饮食指南的解释 SUB-POP 是一项将招募的新颖随机对照试验。 超重或肥胖的成年普通 SSB 消费者，以评估用 SSB 替代 SSB 的有效性 我们的试验将利用现代招募方法，在现实世界、非盲环境中提供无热量选择。 实现 ≥30% 的非白人参与者，实施创新的干预措施、依从性和数据 收集工具，并划分两种最常见的人造甜味剂类型以探索潜力 基本上不含卡路里和糖的 ASB 是否能提供健康尚不清楚。 因此，通过解决这一巨大差距，在习惯性 SSB 消费者中过渡到水。 我们了解如何解决高度普遍且令人担忧的饮食暴露问题，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。