NCT01611649已完成2 期
Profilo Degli Acidi Grassi Omega-3 Dei Globuli Rossi in Neonati Sani Alimentati Con Una Formula Per l'Infanzia Contenente Una Miscela di Grassi Del Latte e Oli Vegetali
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Lactalis
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Sum of omega-3 fatty acid levels in membrane phospholipids of RBC
研究概览
简要总结
The objective of this study is to determine whether the use of a mix of dairy lipids and plant oils in infant formula can increase the sum of omega-3 fatty acids levels in membrane phospholipids of red blood cells (RBC) in 4 month-old infants compared with a formula containing only lipids of plant origin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full term healthy newborn from normal pregnancy
- •Newborn whose mother decided to not breastfeed or to stop breastfeed before the third week of life
排除标准
- •Newborn with low-birth-weight (<2500 g)
- •Newborn whose parents have planned a move within 6 months after birth
- •Family history of allergy to milk protein
结局指标
主要结局
Sum of omega-3 fatty acid levels in membrane phospholipids of RBC
时间窗: after 4 months of consumption
alpha linolenic acid (ALA) + eicosapentaenoic acid (EPA) + docosapentaenoic acid (DPA) + docosahexaenoic acid (DHA)
次要结局
- Serum total fatty acid levels(after 4 months of consumption)
- Insulin-like Growth Factor 1 (IGF1) blood levels(after 4 months of consumption)
- Lipid profile (triglyceride, high-density lipoprotein HDL, low-density lipoprotein LDL, total cholesterol)(after 4 months of consumption)
- Amount of formula consumed, occurrence of spit-up and vomit, description of the number, color and consistency of infant stools as a measure of tolerance to the formula(during the 4 months consumption period)
- Growth parameters: weight, height, head circumference and body composition: amount of lean and fat mass(during the 4 months consumption period)
- Total fatty acid levels in membrane phospholipids of RBC(after 4 months of consumption)
- Evolution of blood total fatty acids levels between 0 and 4 months(between 0 and 4 months)
研究者
研究点 (1)
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