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Polyunsaturated Fatty Acids in Child Nutrition

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01487889
Acronym
PINGU
Enrollment
214
Registered
2011-12-08
Start date
2011-04-30
Completion date
2013-09-30
Last updated
2014-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Acid Status

Brief summary

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.

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.

Interventions

OTHERFatty acid composition of complementary food

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

Sponsors

Dr. von Hauner Children's Hospital, Germany
CollaboratorUNKNOWN
University of Potsdam
CollaboratorOTHER
Pediatric Clinic Dortmund, Germany
CollaboratorUNKNOWN
Research Institute of Child Nutrition, Dortmund
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 8 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Infants´ fatty acid status10 months after deliveryFatty 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

MeasureTime frameDescription
Infants´ cognitive development10 months after deliveryInfants´ cognitive development is assessed using the Bayley II scale.
Infants´ haemogram10 months after delivery
Infants´antioxidant status10 months after delivery
Infants´ body weight10 months after delivery
Infants´ dietary intakefrom 2 until 10 months after delivery
Maternal dietary intakepregnancy and first 2 months post partum
Infants´ visual development10 months after deliveryInfants´ visual development is assessed using the visual evoked potentials method.
Infant's preference for new flavour10 month after delivery
Parental attitudes about fish and feeding strategies10 months after delivery
Mother´s fatty acid status2 months after deliveryFatty 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 length10 months after delivery
Infant´s head circumference10 months after delivery
Infant's preference for fish10 month after delivery

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026