Milk Type in Toddlers (Milk-TOT) Study: Impact of Whole versus Low-fat Milk on Child Adiposity, Health and Development

幼儿牛奶类型 (Milk-TOT) 研究：全脂牛奶与低脂牛奶对儿童肥胖、健康和发育的影响

• 批准号: 10735791
• 负责人: Anisha Indravadan Patel
• 金额: $ 75.73万
• 依托单位: UNIV OF CALIF/DIV/AGRICULTURE/NAT/RESOUR
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10735791
• 关键词: 1 year old; 2 year old; 3 year old; 5 year old; Adolescent obesity; Adult; Affect; Age; Appetite Regulation; Body mass index; Brain; Calories; Cardiometabolic Disease; Caring; Cattle; Characteristics; Child; Childhood; Clinical; Consumption; Development; Diet; Dietary intake; Energy Intake; Ensure; Epidemic; Essential Fatty Acids; Fatty acid glycerol esters; Food; Growth; Guidelines; Health; Health Personnel; Height; Home; Hormones; Household; Human Milk; Infant; Insulin Resistance; Intake; Leptin; Measurement; Measures; Metabolic; Milk; Neurocognitive; Nursery Schools; Nutrient; Nutrition Policy; Obesity; Observational Study; Outcome; Outcome Study; Overweight; Parents; Participant; Policies; Preschool Child; Prevalence; Proteins; Public Health; Randomized; Randomized, Controlled Trials; Recommendation; Risk Factors; Role; Satiation; School-Age Population; Source; Standardization; Surveys; Testing; Time; Toddler; Underweight; Vitamin D; Weight; Woman; adult obesity; blood lipid; cardiometabolism; comorbidity; dietary; disorder risk; drinking; evidence base; excessive weight gain; follow up assessment; follow-up; gut microbiota; indexing; infancy; microbiota; milk fat; milk intake; nutrition; obesity in children; obesity prevention; pediatrician; primary outcome; programs; recruit; saturated fat; secondary outcome; sugar; waist circumference

1 Abstract 2 The prevalence of child obesity in the U.S. has tripled since the 1970s and excess weight gain – even in young 3 children – is a precursor to adult obesity and associated co-morbidities. In the U.S. it is recommended that 4 children consume whole cow’s milk (3.5% fat) from ages 1 to 2 years to support rapid early growth and brain 5 development, and then at age 2 years transition to low-fat (1%) or non-fat milk to reduce saturated fat and 6 calorie intake. Surprisingly few rigorous trials support recommendations regarding the optimal amount of fat in 7 milk. Paradoxically, existing observational studies suggest that lower fat milk consumption is associated with 8 increased adiposity in children. The effects of the types of fat found in milk on cardiometabolic disease risk 9 have also been questioned. We propose a randomized controlled trial to evaluate the effect of consumption of 10 whole versus 1% milk on child adiposity and other health and developmental outcomes beginning after 11 toddlers have successfully transitioned from breastmilk and/or formula to cow’s milk at 2 years of age. For the 12 proposed trial, Milk Type in Toddlers (Milk-TOT) Study, we will recruit 625 parents of toddlers and randomly 13 assign them to either whole or 1% milk groups for 1 year. Our primary aim is to determine how milk fat type 14 (whole versus 1%) consumed from age 2 to 3 years affects change in adiposity as measured by waist-to-height 15 ratio (primary outcome), and body mass index z-score, tri-ponderal mass index, and waist circumference z- 16 score (secondary outcomes). Secondary aims are to evaluate how milk type consumed from age 2 to 3 years 17 affects changes in milk, total and saturated fat, added sugars, total energy intake and overall diet quality, as 18 well as blood lipids, glucoregulatory indices, vitamin D status, and neurocognitive development. An exploratory 19 aim will assess changes in gut microbiota. Results from the Milk-TOT Study will inform evidence-based 20 recommendations about the optimal milk fat that children need to optimize their growth, development, and 21 health. Such recommendations will influence healthcare provider advice about the type of milk that children 22 consume as well as inform federal nutrition programs that collectively provide milk to half of young children in 23 the U.S.

1篇摘要 2自20世纪70年代以来，美国儿童肥胖症的患病率增加了两倍， 3个孩子-是成人肥胖和相关并发症的前兆。在美国，建议 4儿童从1岁到2岁食用全脂牛奶（3.5%脂肪），以支持快速的早期生长和大脑 5发育，然后在2岁时过渡到低脂（1%）或脱脂牛奶，以减少饱和脂肪和 6卡路里的摄入量令人惊讶的是，很少有严格的试验支持关于最佳脂肪量的建议， 7牛奶奇怪的是，现有的观察性研究表明，低脂肪牛奶的消费与 8儿童肥胖症的增加。牛奶中脂肪类型对心脏代谢疾病风险的影响 9人也受到质疑。我们提出了一个随机对照试验，以评估消费的影响， 10全脂牛奶与1%牛奶对儿童肥胖和其他健康和发育结果的影响 11名幼儿在2岁时成功地从母乳和/或配方奶粉过渡到牛奶。为 12拟议的试验，幼儿牛奶类型（牛奶TOT）研究，我们将招募625名幼儿的父母， 13将他们分配到全脂或1%牛奶组1年。我们的主要目的是确定牛奶脂肪类型 2至3岁食用14（全部与1%）影响肥胖的变化，以腰围与身高为衡量标准 15比值（主要结局）、体重指数z评分、三重体重指数和腰围z评分。 16分（次要结局）。次要目的是评估2至3岁的牛奶类型 17影响牛奶、总脂肪和饱和脂肪、添加糖、总能量摄入和整体饮食质量的变化， 18以及血脂、葡萄糖调节指数、维生素D状态和神经认知发育。探索性 19 aim将评估肠道微生物群的变化。Milk-TOT研究的结果将为基于证据的 20建议有关的最佳牛奶脂肪，儿童需要优化他们的生长，发展，和 21健康这些建议将影响医疗保健提供者关于儿童所需牛奶类型的建议。 22消费以及告知联邦营养计划，共同提供牛奶的一半幼儿在 23美国