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Polyunsaturated Fatty Acids in Child Nutrition (PINGU)

5. november 2014 opdateret af: Research Institute of Child Nutrition, Dortmund

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

214

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Dortmund, Tyskland, 44225
        • Research Institute of Child Nutrition

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 1 måned (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Rapeseed oil
Study group receive commercial vegetable-potato-meat-meals containing rapeseed oil as part of complementary food
Andet: 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
Eksperimentel: Fatty fish
Study group receive 2 times per week a vegetable-potato-meat-meals as part of complementary food.
Andet: 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
Aktiv komparator: Corn oil
Study group receive commercial vegetable-potato-meat-meals containing corn oil as part of complementary food
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Infants´ fatty acid status
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Infants´ visual development
Tidsramme: 10 months after delivery
Infants´ visual development is assessed using the visual evoked potentials method.
10 months after delivery
Infants´ cognitive development
Tidsramme: 10 months after delivery
Infants´ cognitive development is assessed using the Bayley II scale.
10 months after delivery
Infants´ haemogram
Tidsramme: 10 months after delivery
10 months after delivery
Infants´antioxidant status
Tidsramme: 10 months after delivery
10 months after delivery
Infants´ body weight
Tidsramme: 10 months after delivery
10 months after delivery
Infants´ dietary intake
Tidsramme: from 2 until 10 months after delivery
from 2 until 10 months after delivery
Maternal dietary intake
Tidsramme: pregnancy and first 2 months post partum
pregnancy and first 2 months post partum
Infant's preference for fish
Tidsramme: 10 month after delivery
10 month after delivery
Infant's preference for new flavour
Tidsramme: 10 month after delivery
10 month after delivery
Parental attitudes about fish and feeding strategies
Tidsramme: 10 months after delivery
10 months after delivery
Mother´s fatty acid status
Tidsramme: 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
Tidsramme: 10 months after delivery
10 months after delivery
Infant´s head circumference
Tidsramme: 10 months after delivery
10 months after delivery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Research Institute of Child Nutrition, Dortmund

Samarbejdspartnere

University of Potsdam
Dr. von Hauner Children's Hospital, Germany
Pediatric Clinic Dortmund, Germany

Efterforskere

  • Studieleder: Mathilde Kersting, Professor, Research Institute of Child Nutrition

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2011

Primær færdiggørelse (Faktiske)

1. september 2013

Studieafslutning (Faktiske)

1. september 2013

Datoer for studieregistrering

Først indsendt

15. september 2011

Først indsendt, der opfyldte QC-kriterier

6. december 2011

Først opslået (Skøn)

8. december 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. november 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. november 2014

Sidst verificeret

1. november 2014

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • PINGU0911DO

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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