NCT00631046已完成不适用
The Importance of Increasing Intake of Essential Fatty Acids During Complementary Feeding on Infant Growth and Body Composition, Intestinal Health, Immune Function and Risk Markers for Later Metabolic Complications.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Growth
研究概览
简要总结
The objective of this intervention study is to examine the effect of n-3 LCPUFA on growth and body composition, intestinal health and microbiotic composition, immune function and risk markers for later diseases in 9-18 months old infants and toddlers.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Months 至 19 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton infants, 9 mo +/- 2 wk, born >= 37 wk of gestation
- •Birth weight >=2500g, a 5-min Apgar score >= 7, birth weight >= 5th percentile for gestational age
排除标准
- •Chronic diseases expected to influence growth and dietary intake
- •Use of medicine expected to influence growth and dietary intake
- •Fish oil supplementation
结局指标
主要结局
Growth
Body composition
Intestinal microbiota
Blood pressure
Plasma lipid profile
Insulin - glucose
Erythrocyte fatty acid composition
Ex vivo cytokine production
IGF-1 and IGFBP-3
Adipokines
Plasma CRP
Plasma IgE
次要结局
- Glucagon
- Metagenome analysis (investigating the enzymatic capacity of the intestines through prokaryotic DNA sequencing)
- Iron status (hemoglobin, ferritin)
- faecal calprotectin
- FADS1 and FADS2 genotypes
- Allergy status
研究者
研究点 (2)
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