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

1摘要 自20世纪70年代以来，美国儿童肥胖症的流行率增加了两倍，体重超标--即使是在年轻人 3个孩子-是成人肥胖和相关共病的先兆。在美国，建议 4名儿童从1岁到2岁食用全脂牛奶(3.5%脂肪)，以支持快速早期发育和大脑 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卡路里摄入量。令人惊讶的是，很少有严格的试验支持关于人体内最佳脂肪量的建议 7杯牛奶。矛盾的是，现有的观察性研究表明，较低的脂肪牛奶摄入量与 8儿童肥胖症增加。牛奶中脂肪种类对心脏代谢性疾病风险的影响 9人也受到了讯问。我们提出了一项随机对照试验来评估消费的效果 10%全脂牛奶与1%牛奶对儿童肥胖及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。对于 12建议的试验，幼儿的牛奶类型(Milk-TOT)研究，我们将招募625名幼儿父母和随机 13将他们分成全脂牛奶组或1%牛奶组，为期一年。我们的主要目标是确定乳脂类型 从2岁到3岁摄入14%(整体与1%)会影响以腰围到身高衡量的肥胖症的变化 15比率(主要结果)，以及体重指数z得分、三体质量指数和腰围z- 16分(二次结局)。次要目标是评估2至3岁儿童的牛奶类型 17影响牛奶、总脂肪和饱和脂肪、添加糖、总能量摄入量和整体饮食质量的变化，如 18以及血脂、血糖调节指数、维生素D状况和神经认知发育。探索性的 19 AIM将评估肠道微生物区系的变化。Milk-TOT研究的结果将为基于证据的 关于儿童最佳乳脂的20条建议，以优化他们的生长、发育和 21健康。这样的建议将影响医疗保健提供者关于儿童牛奶类型的建议 22消费并告知联邦营养计划，这些计划总共向#年一半的幼儿提供牛奶 23日，美国

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.