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.

Study Overview

• Status: Completed
• Conditions: Fatty Acid Status
• Intervention / Treatment: Other: Fatty acid composition of complementary food

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.

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dortmund, Germany, 44225
    • Research Institute of Child Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infants´ fatty acid status	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infants´ visual development	Infants´ visual development is assessed using the visual evoked potentials method.	10 months after delivery
Infants´ cognitive development	Infants´ cognitive development is assessed using the Bayley II scale.	10 months after delivery
Infants´ haemogram		10 months after delivery
Infants´antioxidant status		10 months after delivery
Infants´ body weight		10 months after delivery
Infants´ dietary intake		from 2 until 10 months after delivery
Maternal dietary intake		pregnancy and first 2 months post partum
Infant's preference for fish		10 month after delivery
Infant's preference for new flavour		10 month after delivery
Parental attitudes about fish and feeding strategies		10 months after delivery
Mother´s fatty acid status	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		10 months after delivery
Infant´s head circumference		10 months after delivery

Collaborators and Investigators

• Sponsor: Research Institute of Child Nutrition, Dortmund
• Collaborators: University of Potsdam; Dr. von Hauner Children's Hospital, Germany; Pediatric Clinic Dortmund, Germany
• Investigators: Study Director: Mathilde Kersting, Professor, Research Institute of Child Nutrition

Publications and helpful links

General Publications

• Libuda L, Mesch CM, Stimming M, Demmelmair H, Koletzko B, Warschburger P, Blanke K, Reischl E, Kalhoff H, Kersting M. Fatty acid supply with complementary foods and LC-PUFA status in healthy infants: results of a randomised controlled trial. Eur J Nutr. 2016 Jun;55(4):1633-44. doi: 10.1007/s00394-015-0982-2. Epub 2015 Jul 14.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: September 15, 2011
• First Submitted That Met QC Criteria: December 6, 2011
• First Posted (Estimate): December 8, 2011

Study Record Updates

• Last Update Posted (Estimate): November 6, 2014
• Last Update Submitted That Met QC Criteria: November 5, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: PINGU0911DO