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 简介：我们的目标是对来自一个随机化的综合数据集进行二次数据分析。 对照试验（RCT）旨在确定早期差异的能量平衡机制 喂食蛋白质形式不同的等热量婴儿配方奶粉的婴儿体重增加。 除了完成主要目标外，我们还从母亲那里收集了多种多样的表型- RCT期间的婴儿二对，从产后2周持续到婴儿12.5个月， 随访1.5年。因此，我们有一个独特的机会，超越了目标， 最初的随机对照试验，以评估早期饮食对高度普遍的 营养方案。 该试验随机选择了一组健康婴儿（60%为美国黑人）， (CMF)或等热量的广泛水解配方奶粉（EHF）的第一年的生活。随机分配至CMF， 与流行性出血热相比，显著增加了早期体重快速增加的可能性，这是后来肥胖的危险因素， 通过能量进出的差异。整个研究期间收集的其他表型（次要结局） RCT包括发育里程碑、饮食、母亲喂养方式、食物偏好和 味觉基因型将对这些数据进行二次分析，并根据假设， 与人体测量、早期体重增加、肥胖和身体活动的主要结果相比。 该建议的核心是五个目标，完成后将产生至少六个出版物。AIM 1将 测试提出的风险因素（早期体重快速增加，体力活动少，运动发育延迟）和 生物标志物（乳牙萌出的时间），独立或组合，预测肥胖和Z评分 12.5个月和1.5年。AIM 2将根据每月的饮食记录确定配方奶粉喂养模式， 从问卷调查母亲的喂养习惯，以测试假设，即类型的公式在瓶子里， 与母亲的喂养习惯相比，这是导致早期体重增加轨迹和儿童肥胖的更大因素。 因为EHF比CMF更苦，AIM 3将检验EHF喂养的婴儿比CMF更苦的假设。 比CMF喂养的婴儿更容易接受花椰菜口味的食物;已知苦味受体的遗传变异 西兰花中硫代葡萄糖苷激活的蛋白质的含量将在分析中考虑。AIM 4将描述模式， 长期以来母亲饮食的质量和营养成分及其与子女饮食的一致性。AIM 5 将提供与以下内容相关的描述性数据：（a）每月配方奶粉与非配方奶粉的能量贡献 和（B）确定用于估计婴儿的经验公式的准确性 基础代谢和总能量消耗，通过与能量消耗的实际测量进行比较。 这些分析将增加关于早期方案拟订的知识基础，目的是改善儿童的健康状况， 下一代的婴儿谁是配方奶粉喂养。