NCT00624689已完成不适用
Double-blinded Interventional Study on the Effects of MFGM-enriched Formula With Reduced Energy and Protein Content on Growth and Development
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Body composition
研究概览
简要总结
Formula-fed infants differ from breast-fed infants in the growth pattern, risk for obesity and cardiovascular diseases, neurological development and morbidity in infections.
The investigators' hypothesis is that a modified formula with reduced energy and protein content and enrichment with Milk Fat Globule Membrane (MFGM) containing bioactive proteins and phospholipids will reduce the difference between formula-fed and breast-fed infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term infants with birth weight 2500-4500 gr
- •Fed with breastmilk only or formula only before 2 months of age
排除标准
- •Chronic illness
研究组 & 干预措施
1
Experimental
Modified formula
干预措施: Modified formula (MFGM-enriched formula with reduced energy and protein content) (Dietary Supplement)
2
No Intervention
Standard formula
3
No Intervention
Breastfed
结局指标
主要结局
Body composition
时间窗: 4 months
Pletysmography (% body fat)
次要结局
- Neurological development(1 year)
研究者
Niklas Timby
M.D, Researcher
Umeå University
研究点 (1)
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