Effects of Dietary Protein From Meat vs. Dairy on Infant Growth, Body Composition and Gut Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change of linear growth
研究概览
简要总结
Current research shows that dairy protein accelerates infant weight gain, which is a risk factor for later on obesity and metabolic syndrome. However, dietary protein from other sources haven't been studied yet. This longitudinal study will compare two complementary feeding regimens with dietary protein mainly from 1) meat; 2) dairy on infant growth, body composition and gut microbiome from 5 to 12 months of age in formula fed infants. Healthy infants at approximately 5 months of age will be randomized to either a meat protein, or a dairy protein group with complementary protein mainly from meat or dairy. Infants will consume one of these diets for 7 months (6-12 months of age) and infant growth, body composition, growth biomarkers and gut microbiome will be measured to compare between groups and over time.
详细描述
Two observational follow-up visits will be conducted at 18 and 24 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1-5 months of age
- •Formula fed
- •On breast milk less than 1 month
- •Term Birth (36-42 weeks)
- •Appropriate for gestational age
排除标准
- •Congenital anomalies that impact feeding, growth, or development
- •Low birth weight
- •Not able to consume milk-based formula
- •Known chronic diseases or allergies affecting protein consumption/digestion
研究组 & 干预措施
meat group
Infants in this group will receive complementary foods with high protein content mainly from meat
干预措施: a high-protein complementary diet with meat (Behavioral)
dairy group
infants in this group will receive complementary foods mainly from dairy
干预措施: a high-protein complementary diet with dairy (Behavioral)
结局指标
主要结局
Change of linear growth
时间窗: 6 months
growth, including linear growth (length), body weight, and all the Z scores will be recorded at the beginning and end of the study.
次要结局
- Change in Body composition(5 and 12 months of age)