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摘要 2美国儿童肥胖症的患病率自1970年代以来已经增加了两倍，超过体重增加 - 即使在Young中也是如此 3个儿童 - 是成人肥胖和相关合并症的先驱。在美国，建议 4个儿童从1至2岁时食用全牛奶（3.5％脂肪），以支持快速的早期生长和大脑 5开发，然后在2岁时过渡到低脂（1％）或非脂肪牛奶，以减少饱和脂肪和 6卡路里摄入量。令人惊讶的是，很少有严格的试验支持有关最佳脂肪量的建议 7牛奶。矛盾的是，现有的观察性研究表明，较低的脂肪牛奶消耗与 8儿童的肥胖增加。牛奶中发现的脂肪类型对心脏代谢疾病风险的影响 9也受到质疑。我们提出了一项随机对照试验，以评估消费的影响 从儿童肥胖和其他健康和发育结果开始的10个牛奶开始 11个孩子已经成功地从母乳和/或配方奶粉过渡到2岁的牛奶。为了 12个拟议的试验，幼儿牛奶类型（牛奶 - tot）研究，我们将招募625名幼儿的父母，并随机招募 13将它们分配给全部或1％的牛奶组1年。我们的主要目的是确定牛奶脂肪类型 从2岁到3岁开始消耗的14（整个1％）会影响肥胖的变化。 15（主要结果）和体重指数z得分，三次调查质量指数和腰围z- 16分（次要结果）。次要目的是评估牛奶类型从2岁到3岁的消费方式 17影响牛奶的变化，总脂肪和饱和脂肪，添加的糖，总能量摄入和整体饮食质量，如 18以及血脂，葡萄糖调节指数，维生素D状态和神经认知发展。探索性 19 AIM将评估肠道菌群的变化。牛奶-TOT研究的结果将为循证提供信息 20关于儿童需要优化其增长，发展和的最佳牛奶脂肪的建议 21健康。这些建议将影响医疗保健提供者关于儿童类型的建议 22消费以及通知联邦营养计划，该计划共同向一半的幼儿提供牛奶 23美国