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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Dortmund, Alemanha, 44225
- Research Institute of Child Nutrition
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Rapeseed oil
Study group receive commercial vegetable-potato-meat-meals containing rapeseed oil as part 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.
|
Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition
|
|
Comparador Ativo: Corn oil
Study group receive commercial vegetable-potato-meat-meals containing corn oil as part of complementary food
|
Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Infants´ fatty acid status
Prazo: 10 months after delivery
|
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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Infants´ visual development
Prazo: 10 months after delivery
|
Infants´ visual development is assessed using the visual evoked potentials method.
|
10 months after delivery
|
|
Infants´ cognitive development
Prazo: 10 months after delivery
|
Infants´ cognitive development is assessed using the Bayley II scale.
|
10 months after delivery
|
|
Infants´ haemogram
Prazo: 10 months after delivery
|
10 months after delivery
|
|
|
Infants´antioxidant status
Prazo: 10 months after delivery
|
10 months after delivery
|
|
|
Infants´ body weight
Prazo: 10 months after delivery
|
10 months after delivery
|
|
|
Infants´ dietary intake
Prazo: from 2 until 10 months after delivery
|
from 2 until 10 months after delivery
|
|
|
Maternal dietary intake
Prazo: pregnancy and first 2 months post partum
|
pregnancy and first 2 months post partum
|
|
|
Infant's preference for fish
Prazo: 10 month after delivery
|
10 month after delivery
|
|
|
Infant's preference for new flavour
Prazo: 10 month after delivery
|
10 month after delivery
|
|
|
Parental attitudes about fish and feeding strategies
Prazo: 10 months after delivery
|
10 months after delivery
|
|
|
Mother´s fatty acid status
Prazo: 2 months after delivery
|
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
Prazo: 10 months after delivery
|
10 months after delivery
|
|
|
Infant´s head circumference
Prazo: 10 months after delivery
|
10 months after delivery
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Mathilde Kersting, Professor, Research Institute of Child Nutrition
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- PINGU0911DO
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .