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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

介入性

注册 (实际的)

214

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Dortmund、德国、44225
        • Research Institute of Child Nutrition

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 1个月 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:Rapeseed oil
Study group receive commercial vegetable-potato-meat-meals containing rapeseed oil as part of complementary food
Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition
实验性的:Fatty fish
Study group receive 2 times per week a vegetable-potato-meat-meals as part of complementary food.
Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition
有源比较器:Corn oil
Study group receive commercial vegetable-potato-meat-meals containing corn oil as part of complementary food
Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition

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
Infants´ fatty acid status
大体时间:10 months after delivery
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.
10 months after delivery

次要结果测量

结果测量
措施说明
大体时间
Infants´ visual development
大体时间:10 months after delivery
Infants´ visual development is assessed using the visual evoked potentials method.
10 months after delivery
Infants´ cognitive development
大体时间:10 months after delivery
Infants´ cognitive development is assessed using the Bayley II scale.
10 months after delivery
Infants´ haemogram
大体时间:10 months after delivery
10 months after delivery
Infants´antioxidant status
大体时间:10 months after delivery
10 months after delivery
Infants´ body weight
大体时间:10 months after delivery
10 months after delivery
Infants´ dietary intake
大体时间:from 2 until 10 months after delivery
from 2 until 10 months after delivery
Maternal dietary intake
大体时间:pregnancy and first 2 months post partum
pregnancy and first 2 months post partum
Infant's preference for fish
大体时间:10 month after delivery
10 month after delivery
Infant's preference for new flavour
大体时间:10 month after delivery
10 month after delivery
Parental attitudes about fish and feeding strategies
大体时间:10 months after delivery
10 months after delivery
Mother´s fatty acid status
大体时间:2 months after delivery
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.
2 months after delivery
Infants´ body length
大体时间:10 months after delivery
10 months after delivery
Infant´s head circumference
大体时间:10 months after delivery
10 months after delivery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年4月1日

初级完成 (实际的)

2013年9月1日

研究完成 (实际的)

2013年9月1日

研究注册日期

首次提交

2011年9月15日

首先提交符合 QC 标准的

2011年12月6日

首次发布 (估计)

2011年12月8日

研究记录更新

最后更新发布 (估计)

2014年11月6日

上次提交的符合 QC 标准的更新

2014年11月5日

最后验证

2014年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • PINGU0911DO

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