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| Name | Class |
|---|---|
| Dr. von Hauner Children's Hospital, Germany | UNKNOWN |
| University of Potsdam | OTHER |
| Pediatric Clinic Dortmund, Germany | UNKNOWN |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapeseed oil | Experimental | Study group receive commercial vegetable-potato-meat-meals containing rapeseed oil as part of complementary food |
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| Fatty fish | Experimental | Study group receive 2 times per week a vegetable-potato-meat-meals as part of complementary food. |
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| Corn oil | Active Comparator | Study group receive commercial vegetable-potato-meat-meals containing corn oil as part of complementary food |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathilde Kersting, Professor | Research Institute of Child Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Child Nutrition | Dortmund | 44225 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26169870 | Derived | 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. |
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| 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 |