Polyunsaturated Fatty Acids in Child Nutrition (PINGU)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Dr. von Hauner Children's Hospital, Germany
University of Potsdam, Germany
Pediatric Clinic Dortmund, Germany
Information provided by (Responsible Party):
Research Institute of Child Nutrition, Dortmund
ClinicalTrials.gov Identifier:
NCT01487889
First received: September 15, 2011
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Fatty Acid Status
Other: Fatty acid composition of complementary food

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Polyunsaturated Fatty Acids in Child Nutrition - A German Multimodal Optimisation Study

Resource links provided by NLM:


Further study details as provided by Research Institute of Child Nutrition, Dortmund:

Primary Outcome Measures:
  • Infants´ fatty acid status [ Time Frame: 10 months after delivery ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Infants´ visual development [ Time Frame: 10 months after delivery ] [ Designated as safety issue: No ]
    Infants´ visual development is assessed using the visual evoked potentials method.

  • Infants´ cognitive development [ Time Frame: 10 months after delivery ] [ Designated as safety issue: No ]
    Infants´ cognitive development is assessed using the Bayley II scale.

  • Infants´ haemogram [ Time Frame: 10 months after delivery ] [ Designated as safety issue: No ]
  • Infants´antioxidant status [ Time Frame: 10 months after delivery ] [ Designated as safety issue: No ]
  • Infants´ body weight [ Time Frame: 10 months after delivery ] [ Designated as safety issue: No ]
  • Infants´ dietary intake [ Time Frame: from 2 until 10 months after delivery ] [ Designated as safety issue: No ]
  • Maternal dietary intake [ Time Frame: pregnancy and first 2 months post partum ] [ Designated as safety issue: No ]
  • Infant's preference for fish [ Time Frame: 10 month after delivery ] [ Designated as safety issue: No ]
  • Infant's preference for new flavour [ Time Frame: 10 month after delivery ] [ Designated as safety issue: No ]
  • Parental attitudes about fish and feeding strategies [ Time Frame: 10 months after delivery ] [ Designated as safety issue: No ]
  • Mother´s fatty acid status [ Time Frame: 2 months after delivery ] [ Designated as safety issue: No ]
    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.

  • Infants´ body length [ Time Frame: 10 months after delivery ] [ Designated as safety issue: No ]
  • Infant´s head circumference [ Time Frame: 10 months after delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 171
Study Start Date: April 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rapeseed oil
Study group receive commercial vegetable-potato-meat-meals containing rapeseed oil as part of complementary food
Other: Fatty acid composition of complementary food
Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition
Experimental: Fatty fish
Study group receive 2 times per week a vegetable-potato-meat-meals as part of complementary food.
Other: Fatty acid composition of complementary food
Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition
Active Comparator: Corn oil
Study group receive commercial vegetable-potato-meat-meals containing corn oil as part of complementary food
Other: Fatty acid composition of complementary food
Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 8 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487889

Locations
Germany
Research Institute of Child Nutrition
Dortmund, Germany, 44225
Sponsors and Collaborators
Research Institute of Child Nutrition, Dortmund
Dr. von Hauner Children's Hospital, Germany
University of Potsdam, Germany
Pediatric Clinic Dortmund, Germany
Investigators
Study Director: Mathilde Kersting, Professor Research Institute of Child Nutrition
  More Information

No publications provided

Responsible Party: Research Institute of Child Nutrition, Dortmund
ClinicalTrials.gov Identifier: NCT01487889     History of Changes
Other Study ID Numbers: PINGU0911DO
Study First Received: September 15, 2011
Last Updated: June 3, 2013
Health Authority: Germany: Federal Ministry of Education and Research

ClinicalTrials.gov processed this record on April 17, 2014