Polyunsaturated Fatty Acids in Child Nutrition

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fatty Acid Status

Intervention / Treatment
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* Other: Fatty acid composition of complementary food


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 8 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapeseed oil<br>Study group receive commercial vegetable-potato-meat-meals containing rapeseed oil as part of complementary food | Other: Fatty acid composition of complementary food<br>* Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition<br>|
| Experimental: Fatty fish<br>Study group receive 2 times per week a vegetable-potato-meat-meals as part of complementary food. | Other: Fatty acid composition of complementary food<br>* Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition<br>|
| Active Comparator: Corn oil<br>Study group receive commercial vegetable-potato-meat-meals containing corn oil as part of complementary food | Other: Fatty acid composition of complementary food<br>* Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition<br>|

What is the study measuring?
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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 |