Polyunsaturated Fatty Acids in Child Nutrition (PINGU)
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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 |
- 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 membrans, whole plasma, and cheek cells in order to assess the fatty acid composition.
- 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 membrans, 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: | January 2013 |
| Estimated Primary Completion Date: | January 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 |
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| Germany | |
| Research Institute of Child Nutrition | |
| Dortmund, Germany, 44225 | |
| 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: | December 6, 2011 |
| Health Authority: | Germany: Federal Ministry of Education and Research |
ClinicalTrials.gov processed this record on May 23, 2013