Evidence map›Paper›PMID 23072617›Full record

Trial reportBMC pediatrics2012

The influence of a formula supplemented with dairy lipids and plant oils on the erythrocyte membrane omega-3 fatty acid profile in healthy full-term infants: a double-blind randomized controlled trial.

Maria Lorella Giannì, Paola Roggero, Charlotte Baudry, Amandine Ligneul, Daniela Morniroli, Francesca Garbarino, Pascale le Ruyet, Fabio Mosca

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pediatrics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01611649 (Profilo Degli Acidi Grassi Omega-3 Dei Globuli Rossi in Neonati Sani Alimentati Con Una Formula Per l'Infanzia Contenente Una Miscela di Grassi Del Latte e Oli Vegetali), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01611649 phase2completednot on this map

Profilo Degli Acidi Grassi Omega-3 Dei Globuli Rossi in Neonati Sani Alimentati Con Una Formula Per l'Infanzia Contenente Una Miscela di Grassi Del Latte e Oli Vegetali

TypeinterventionalSponsorLactalisRan2012Enrolled117ConditionsInfant DevelopmentArmsFormula containing dairy lipids and plant oils, Formula containing plant oils, Formula containing dairy lipids and plant oils, DHA+ARA
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 2 countries.

Maria Lorella GiannìNeonatal Intensive Care Unit (NICU), Department of Clinical Science and Comunity Health, Fondazione IRCCS,Ca' Granda, Ospedale Maggiore Policlinico, University of Milan, Milan, Italy. maria.gianni@unimi.it
Paola Roggero
Charlotte Baudry
Amandine Ligneul
Daniela Morniroli
Francesca Garbarino
Pascale le Ruyet
Fabio Mosca
University of Milan · ITPérinatalité & Risques Toxiques · FRFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHuman milk is the optimal nutrition for infants. When breastfeeding is not possible, supplementation of infant formula with long chain polyunsaturated fatty acids appears to promote neurodevelopmental outcome and visual function. Plant oils, that are the only source of fat in most of infant formulas, do not contain specific fatty acids that are present in human and cow milk and do not encounter milk fat triglyceride structure. Experimental data suggest that a mix of dairy lipids and plant oils can potentiate endogenous synthesis of n-3 long chain polyunsaturated fatty acids. This trial aims to determine the effect of an infant formula supplemented with a mixture of dairy lipids and plant oils on the erythrocyte membrane omega-3 fatty acid profile in full-term infants (primary outcome). Erythrocyte membrane long chain polyunsaturated fatty acids and fatty acids content, the plasma lipid profile and the insulin-growth factor 1 level, the gastrointestinal tolerance, the changes throughout the study in blood fatty acids content, in growth and body composition are evaluated as secondary outcomes. METHODS/

designIn a double-blind controlled randomized trial, 75 healthy full-term infants are randomly allocated to receive for four months a formula supplemented with a mixture of dairy lipids and plant oils or a formula containing only plant oils or a formula containing plant oils supplemented with arachidonic acid and docosahexaenoic acid. Twenty-five breast-fed infants constitute the reference group. Erythrocyte membrane omega-3 fatty acid profile, long chain polyunsaturated fatty acids and the other fatty acids content, the plasma lipid profile and the insulin-growth factor 1 level are measured after four months of intervention. Gastrointestinal tolerance, the changes in blood fatty acids content, in growth and body composition, assessed by means of an air displacement plethysmography system, are also evaluated throughout the study. DISCUSSION: The achievement of an appropriate long chain polyunsaturated fatty acids status represents an important goal in neonatal nutrition. Gaining further insight in the effects of the supplementation of a formula with dairy lipids and plant oils in healthy full-term infants could help to produce a formula whose fat content, composition and structure is more similar to human milk.

trial registrationClinicalTrials.gov Identifier NCT01611649.

Indexed as

Dietary SupplementsErythrocyte MembraneFatty Acids, Omega-3Infant FormulaLipidsPlant OilsAnimalsDouble-Blind MethodHumansInfant, NewbornMilkTerm BirthFatty Acids, Omega-3LipidsPlant Oils

Identifiers

PMID23072617
PMCPMC3480864
OpenAlexW2058091922

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.