Polyunsaturated Fatty Acids in Child Nutrition (PINGU)
Polyunsaturated Fatty Acids in Child Nutrition - A German Multimodal Optimisation Study
Primary objective of this study is to examine the effects of 2 different approaches of dietary strategies to optimise fatty acid composition in complementary food on infant's fatty acid status and its consequences on cognitive and visual development.
Subjects are randomly assigned to one of three groups:
- Rapeseed oil (high in n-3 PUFA and small n-6:n-3 ratio to support endogenous n- 3 LC-PUFA metabolism)
- Fatty fish (preformed n-3 LC-PUFA, especially DHA)
- Corn oil (as control group, high in n-6 PUFA, common in complementary food).
The intervention starts with the beginning of complementary feeding as generally recommended between 4 to 6 months of age and ends at the age of 10 months. For this period of time subjects of all groups receive commercial vegetable-potato-meat-meals as part of complementary food which only differs in the fatty acid composition.
研究概览
详细说明
A well balanced supply of polyunsaturated fatty acids, in particular the omega-3 long chain docosahexaenoic acid (DHA), in early childhood is essential for children's cognitive and visual development. DHA can either be supplied preformed in the diet (e.g. via fatty fish) or synthesised by conversion of its essential precursor alpha-linolenic acid (e.g. via rapeseed oil). The study examines the effect of two different approaches to optimise infants´ fatty acid status.
The study sample consists of healthy newborns and their mothers (3 x 57 infants according to a priori power calculation) who are enrolled in delivery hospitals in the region of Dortmund, Germany. In total, the individual study program covers the first 10 months of infant's life. Biomarkers of fatty acid status from the mother are collected 8 weeks pp for the estimation of pre- and perinatal fatty acid supply. Additionally, information on maternal diet during pregnancy and after delivery is assessed. The intervention covers the period of complementary feeding (from 4 to 6 months of age until 10 months of age). In all groups the specific study food is given 5 to 7 times a week, whereas 2 of these are fish meals in the fatty fish group. At the age of 4 and 10 months blood samples are collected from the infants to examine the effect on blood fatty acid status. Parameters of visual and cognitive development are also assessed at the age of 4 and 10 months using VEP examinations and Bayley scales. Infants´ dietary intake is assessed from the end of the 2 months until 10 months of age using continuous weighed dietary records.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Dortmund、德国、44225
- Research Institute of Child Nutrition
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- a term healthy newborn infant ( birth weight > 2500 g, gestational age > 37 weeks
- German speaking mother
- the intention of the mother to breast-feed the children and to feed study menus at least 5 times per week beginning in the fifth to seventh month of life.
Exclusion Criteria:
- preterm children
- twins
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Rapeseed oil
Study group receive commercial vegetable-potato-meat-meals containing rapeseed oil as part of complementary food
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Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition
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实验性的:Fatty fish
Study group receive 2 times per week a vegetable-potato-meat-meals as part of complementary food.
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Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition
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有源比较器:Corn oil
Study group receive commercial vegetable-potato-meat-meals containing corn oil as part of complementary food
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Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Infants´ fatty acid status
大体时间:10 months after delivery
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Fatty acids (saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids including long-chain polyunsaturated fatty acids) are measured in percent of total fatty acids in erythrocyte membranes, whole plasma, and cheek cells in order to assess the fatty acid composition.
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10 months after delivery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Infants´ visual development
大体时间:10 months after delivery
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Infants´ visual development is assessed using the visual evoked potentials method.
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10 months after delivery
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Infants´ cognitive development
大体时间:10 months after delivery
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Infants´ cognitive development is assessed using the Bayley II scale.
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10 months after delivery
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Infants´ haemogram
大体时间:10 months after delivery
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10 months after delivery
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Infants´antioxidant status
大体时间:10 months after delivery
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10 months after delivery
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Infants´ body weight
大体时间:10 months after delivery
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10 months after delivery
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Infants´ dietary intake
大体时间:from 2 until 10 months after delivery
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from 2 until 10 months after delivery
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Maternal dietary intake
大体时间:pregnancy and first 2 months post partum
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pregnancy and first 2 months post partum
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Infant's preference for fish
大体时间:10 month after delivery
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10 month after delivery
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Infant's preference for new flavour
大体时间:10 month after delivery
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10 month after delivery
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Parental attitudes about fish and feeding strategies
大体时间:10 months after delivery
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10 months after delivery
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Mother´s fatty acid status
大体时间:2 months after delivery
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Fatty acids (saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids including long-chain polyunsaturated fatty acids) are measured in percent of total fatty acids in erythrocyte membranes, whole plasma, cheek cells, and breast milk in order to assess the fatty acid composition.
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2 months after delivery
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Infants´ body length
大体时间:10 months after delivery
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10 months after delivery
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Infant´s head circumference
大体时间:10 months after delivery
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10 months after delivery
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合作者和调查者
合作者
调查人员
- 研究主任:Mathilde Kersting, Professor、Research Institute of Child Nutrition
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- PINGU0911DO
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