Evidence map›Paper›PMID 40910342›Full record

Trial reportJournal of pediatric gastroenterology and nutrition2025

Immunological effects of alpha-lactalbumin-enriched low-protein infant formula: A randomized controlled trial.

Ulrika T Nilsson, Olle Hernell, Bo Lönnerdal, Lotte N Jacobsen, Maria Nunez-Salces, Anne S Kvistgaard, Christina West, Pia K Åkeson

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of pediatric gastroenterology and nutrition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
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.

Ulrika T NilssonDepartment of Clinical Sciences Malmö, Pediatrics, Lund University, Malmö, Sweden.ORCID https://orcid.org/0009-0009-8911-703X
Olle HernellDepartment of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.ORCID https://orcid.org/0000-0001-8841-6200
Bo LönnerdalDepartment of Nutrition, University of California, Davis, Davis, California, USA.ORCID https://orcid.org/0000-0002-3459-2484
Lotte N JacobsenArla Foods Ingredients Group P/S, Viby, Denmark.
Maria Nunez-SalcesArla Foods Ingredients Group P/S, Viby, Denmark.ORCID https://orcid.org/0000-0002-1879-7797
Anne S KvistgaardArla Foods Ingredients Group P/S, Viby, Denmark.
Christina WestDepartment of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.ORCID https://orcid.org/0000-0001-9599-2580
Pia K ÅkesonDepartment of Clinical Sciences Malmö, Pediatrics, Lund University, Malmö, Sweden.ORCID https://orcid.org/0000-0003-2010-3130

Funding

Arla Foods Ingredients Group P/S, Viby J, DenmarkRegion Skåne Council Foundation for Research and Development
6 · The paper itself

Abstract

objectivesBreast-fed (BF) have lower risk of infections during infancy compared to those formula-fed (FF). A higher content of alpha-lactalbumin (α-lac) in breast milk, which may promote a more favorable gut microbiota, could be one reason. In this study, we evaluated whether increased concentration of α-lac in low-protein infant formula affects the immune response and the incidence of infections during infancy.

methodsIn a double-blinded randomized controlled trial, healthy-term infants (n = 245) received low-protein infant formulas with α-lac-enriched whey (α-lac-EW; 1.75 g protein/100 kcal, 27% α-lac) or casein glycomacropeptide-reduced whey (CGMP-RW; 1.76 g protein/100 kcal, 14% α-lac), or standard formula (SF; 2.2 g protein/100 kcal, 10% α-lac) from 2 to 6 months. BF constituted a reference group. Cytokines and high-sensitivity C-reactive protein (hsCRP) were measured during intervention and infection-related morbidity, and treatment was evaluated until 12 months.

resultsSerum interleukin-6 (IL-6) was lower in BF than in all FF groups during intervention (p < 0.001). No other differences in cytokines (tumor necrosis factor alpha [TNF-α], transforming growth factor beta 1 [TGF-β1], TGF-β2, IL-1, IL-10, IL-12, interferon gamma [INF-γ]) or hsCRP were found among the study groups. Infection-related morbidity did not differ among study groups, except slight differences in the use of antibiotics during (α-lac-EW vs. CGMP-RW [p = 0.008]) and after intervention (α-lac-EW vs. BF [p = 0.016]).

conclusionsIncreased α-lac concentration in low-protein infant formula to levels similar to breast milk did not affect the cytokine profile and had minor effect on infection-related morbidity. The higher IL-6 concentrations in FF than in BF needs further investigation.

Indexed as

Infant FormulaLactalbuminBreast FeedingCaseinsC-Reactive ProteinCytokinesDouble-Blind MethodFemaleGastrointestinal MicrobiomeHumansInfantInfant, NewbornMaleMilk, HumanWhey ProteinsCaseinsC-Reactive ProteinCytokinesLactalbuminWhey Proteinscytokinesgut microbiotainfant nutritioninfectious diseases

Identifiers

PMID40910342
PMCPMC12580452

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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 Socratic graph.