Secondary Analyses of RCT Data on Infant Formula and Nutritional Programming

婴儿配方奶粉和营养规划的随机对照试验数据的二次分析

• 批准号: 9795361
• 负责人: JULIA ANNE MENNELLA
• 金额: $ 7.95万
• 依托单位: MONELL CHEMICAL SENSES CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-27 至 2021-09-26
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9795361
• 关键词: African American; Age; American; Amino Acids; Anthropometry; Award; Beverages; Biological Markers; Breast Feeding; Broccoli - dietary; Categories; Cattle; Cereals; Child; Comorbidity; Cross-Sectional Studies; Data; Data Analyses; Data Set; Deposition; Development; Diet; Diet Records; Dietary Practices; Dietary intake; Energy Intake; Energy Metabolism; Energy-Generating Resources; Equation; Evaluation; Factor Analysis; Feces; Feeding Patterns; Feeds; Food; Food Preferences; Formula Diets; Genetic; Genetic Variation; Genotype; Glucosinolates; Goals; Growth; Health; Heart; Infant; Infant formula; Instruction; Intake; Knowledge; Life; Manuscripts; Measures; Metabolic; Minority; Modeling; Mothers; Motor; Nutrient; Nutritional; Obesity; Observational Study; Paper; Pattern; Pediatrics; Peptides; Phenotype; Physical activity; Postpartum Period; Proteins; Publications; Publishing; Questionnaires; Randomized; Randomized Controlled Trials; Receptor Gene; Records; Research; Risk; Risk Factors; Savory; Secondary to; Sleep; Taste Buds; Taste Perception; Testing; Time; Tooth eruption; United States National Institutes of Health; Vegetables; Weight Gain; Work; adult obesity; age group; base; cohort; cost; deciduous tooth; energy balance; experience; falls; feeding; follow-up; food flavor; imprint; improved; infancy; knowledge base; maternal obesity; next generation; nutrition; obesity biomarkers; obesity in children; person centered; preference; primary outcome; programs; randomized trial; secondary analysis; secondary outcome; skills; statistics; total energy expenditure; treatment effect; treatment group; trial design

PROJECT ABSTRACT Précis: Our goal is to conduct secondary data analyses on a comprehensive data set from a randomized controlled trial (RCT) designed to determine the energy balance mechanisms underlying the differential early weight gain experienced by infants who were fed isocaloric infant formulas that differed in the form of protein. In addition to accomplishing the primary aims, we collected multiple and diverse phenotypes from mother- infant dyads during the RCT, which lasted from 2 weeks postpartum until infants were 12.5 months, with a follow-up evaluation at 1.5 years. Therefore, we have a unique opportunity that go beyond the goals of the original RCT to assess direct and indirect effects of early diet on the highly pervasive phenomenon of nutritional programming. The trial randomized a diverse group of healthy infants (60% black Americans) to feed either cow milk formula (CMF) or an isocaloric extensively hydrolyzed formula (EHF) for the first year of life. Randomization to CMF, compared to EHF, significantly increased the likelihood of early rapid weight gain, a risk factor for later obesity, via differences in energy in and out. Additional phenotypes (secondary outcomes) collected throughout the RCT included measures of developmental milestones, diet, maternal feeding styles, food preferences, and taste genotype. These data will be subjected to secondary analyses and, depending on the hypothesis, compared with primary outcomes of anthropometry, early weight gain, adiposity, and physical activity. At the heart of the proposal are five aims, which upon completion will yield at least six publications. AIM 1 will test how proposed risk factors (early rapid weight gain, low physical activity, delayed motor development) and biomarkers (timing of primary teeth eruption), independently or in combination, predict adiposity and Z scores at 12.5 months and 1.5 years. AIM 2 will determine from monthly diet records the formula-feeding patterns and from questionnaires the feeding practices of mothers, to test the hypothesis that type of formula in the bottle is a bigger contributor to early weight gain trajectories and childhood obesity than are maternal feeding practices. Because EHF tastes more bitter than CMF, AIM 3 will test the hypothesis that EHF-fed infants will be more accepting than CMF-fed infants of broccoli-flavored food; genetic variation in a known bitter taste receptor activated by glucosinolates in broccoli will be factored in the analyses. AIM 4 will characterize the pattern, quality, and nutrient content of the diet of mothers over time and concordance with their children’s diets. AIM 5 will provide descriptive data related to (a) contribution of energy from formula versus non-formula each month during the first year of life and (b) determination of the accuracy of empiric equations used to estimate infant basal metabolic and total energy expenditure, by comparisons with actual measures of energy expenditure. These analyses will add to the knowledge base on early programming, with the goal of improving the health of the next generation of infants who are formula fed.

项目摘要 概要：我们的目标是对随机数据集的综合数据集进行二次数据分析 对照试验（RCT）旨在确定早期差异背后的能量平衡机制 喂养蛋白质形式不同的等热量婴儿配方奶粉的婴儿体重增加。 除了实现主要目标外，我们还从母体中收集了多种不同的表型 随机对照试验期间的婴儿二人组，从产后 2 周持续到婴儿 12.5 个月大， 因此，我们有一个超越目标的独特机会。 最初的随机对照试验旨在评估早期饮食对高度普遍的现象的直接和间接影响 营养规划。 该试验随机抽取不同组的健康婴儿（60% 美国黑人）来喂养两种配方奶粉 (CMF) 或生命第一年的等热量主要水解配方奶粉 (EHF)，随机分配至 CMF， 与 EHF 相比，显着增加了早期体重快速增加的可能性，这是后期肥胖的危险因素， 通过整个过程中收集的能量进出的差异（次要结果）。 随机对照试验包括对发育里程碑、饮食、母亲喂养方式、食物偏好和 这些数据将进行二次分析，并根据假设， 与人体测量、早期体重增加、肥胖和体力活动等主要结果相比。 该提案的核心是五个目标，完成后将产生至少六项出版物。 测试所提出的风险因素（早期体重快速增加、体力活动少、运动发育迟缓）和 生物标志物（乳牙萌出时间）可单独或组合预测肥胖和 Z 分数 AIM 2 将在 12.5 个月和 1.5 岁时根据每月饮食记录确定配方奶喂养模式和 通过对母亲的喂养习惯进行问卷调查，检验瓶中配方奶类型是 与母亲的喂养方式相比，它对早期体重增加轨迹和儿童肥胖的影响更大。 由于 EHF 的味道比 CMF 更苦，AIM 3 将检验以下假设：EHF 喂养的婴儿会更苦。 与 CMF 喂养的婴儿相比，接受西兰花味食物的已知苦味受体存在遗传变异； 西兰花中的芥子油苷激活将被纳入分析中，AIM 4 将表征该模式。 随着时间的推移，母亲饮食的质量和营养含量以及与孩子饮食的一致性 AIM 5。 将提供与 (a) 每月配方奶与非配方奶的能量贡献相关的描述性数据 生命第一年期间的情况以及 (b) 确定用于估计婴儿的经验方程的准确性 代谢和总能量消耗，与能量消耗的实际测量值进行比较。 这些分析将增加早期编程的知识库，目标是改善人们的健康 配方奶喂养的下一代婴儿。