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Completed

NCT Number: NCT01487889

Polyunsaturated Fatty Acids in Child Nutrition

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.

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Key information

Conditions

Age range

Up to 8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Institute of Child Nutrition

Dortmund, 44225, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fatty acid composition of complementary food

Other

Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition

Primary outcomes

  1. Infants´ fatty acid status

    Time frame: 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.

Secondary outcomes

  1. Infants´ visual development

    Time frame: 10 months after delivery

    Infants´ visual development is assessed using the visual evoked potentials method.

  2. Infants´ cognitive development

    Time frame: 10 months after delivery

    Infants´ cognitive development is assessed using the Bayley II scale.

  3. Infants´ haemogram

    Time frame: 10 months after delivery

  4. Infants´antioxidant status

    Time frame: 10 months after delivery

  5. Infants´ body weight

    Time frame: 10 months after delivery

  6. Infants´ dietary intake

    Time frame: from 2 until 10 months after delivery

  7. Maternal dietary intake

    Time frame: pregnancy and first 2 months post partum

  8. Infant's preference for fish

    Time frame: 10 month after delivery

  9. Infant's preference for new flavour

    Time frame: 10 month after delivery

  10. Parental attitudes about fish and feeding strategies

    Time frame: 10 months after delivery

  11. Mother´s fatty acid status

    Time frame: 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.

  12. Infants´ body length

    Time frame: 10 months after delivery

  13. Infant´s head circumference

    Time frame: 10 months after delivery

Sponsors and collaborators

Lead sponsor

Research Institute of Child Nutrition, Dortmund

Other

Collaborators

  • Dr. von Hauner Children's Hospital, Germany
  • Pediatric Clinic Dortmund, Germany
  • University of Potsdam

Registry information

Official study title

Polyunsaturated Fatty Acids in Child Nutrition - A German Multimodal Optimisation Study

Acronym: PINGU

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 8, 2011
Registry last updated
Nov 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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