Evidence map›Paper›PMID 41540496›Full record

Trial reportJournal of pediatric gastroenterology and nutrition2026

Metabolic and hormonal serum markers in early childhood: Follow-up of a randomized controlled trial during infancy evaluating a modified, low-protein infant formula.

Jacqueline Muts, Stefanie M P Kouwenhoven, Nadja Antl, Marieke Abrahamse-Berkeveld, Britt J van Keulen, Hans Demmelmair, Lesca M Holdt, Wolfgang Wilfert, Chris H P van den Akker, Johannes B van Goudoever and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of pediatric gastroenterology and nutrition, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

11 authors.

Jacqueline MutsDepartment of Pediatrics, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.ORCID https://orcid.org/0000-0001-9471-8168
Stefanie M P KouwenhovenDepartment of Pediatric & Neonatal Intensive Care, Erasmus MC-Sophia, Rotterdam, the Netherlands.
Nadja AntlDepartment Paediatrics, Division of Metabolic and Nutritional Medicine, Dr. von Hauner Children's Hospital, LMU University Hospital, LMU Munich, Munich, Germany.
Marieke Abrahamse-BerkeveldDanone Research & Innovation, Utrecht, the Netherlands.
Britt J van KeulenDepartment of Pediatrics, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
Hans DemmelmairDepartment Paediatrics, Division of Metabolic and Nutritional Medicine, Dr. von Hauner Children's Hospital, LMU University Hospital, LMU Munich, Munich, Germany.
Lesca M HoldtInstitute of Laboratory Medicine, University Hospital, LMU Munich, Munich, Germany.
Wolfgang WilfertInstitute of Laboratory Medicine, University Hospital, LMU Munich, Munich, Germany.
Chris H P van den AkkerAmsterdam Reproduction & Development Research Institute, Amsterdam UMC, Amsterdam, the Netherlands.
Johannes B van GoudoeverDepartment of Pediatrics, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
Berthold KoletzkoDepartment Paediatrics, Division of Metabolic and Nutritional Medicine, Dr. von Hauner Children's Hospital, LMU University Hospital, LMU Munich, Munich, Germany.

Funding

charitable Else Kröner-Fresenius-Foundation, LMU Medical Faculty and LMU University HospitalsDanone Research & Innovation, UtrechtDZKJ 01GL2406AEU Joint Programming Initiative (JPI HDL)European Commission Framework Programme EarlyNutrition 289346German Ministry of Education and Research 01EA2203Athe German Federal Ministry of Education and Research as part of the German Center for Child and Adolescent Health DZKJ; 01GL2406A
6 · The paper itself

Abstract

objectivesHigh protein intake during infancy has been linked to accelerated weight gain and increased obesity risk. This study aimed to examine the effects of a low-protein formula during the first 6 months of life on blood metabolic and hormonal markers during early childhood.

methodsFormula-fed infants (<45 days) were randomized to receive either a low-protein formula with modified amino acid composition (mLP; n = 90; 1.7 g protein/100 kcal) or a control formula (CTRL; n = 88; 2.1 g protein/100 kcal) until 6 months of age. Breastfed infants served as a reference group (n = 67). Blood samples were collected in cooperating subjects at 1, 2, and 6 years. We measured insulin-like growth factor-1 (IGF-1), IGF-binding proteins (BPs), leptin, glucose, and insulin, and calculated Homeostatic-Model-Assessment-of-Insulin-Resistance (HOMA-IR). Data were analyzed using linear mixed models and linear regression, adjusting for confounders. In addition, results were correlated to priorly published body composition measurement.

resultsVenous blood was collected from 87 (36%), 77 (31%), and 63 (26%) participants at ages 1, 2, and 6 years, respectively. No differences were found in metabolic markers between the formula groups or compared to the breastfed group at any time point. Furthermore, at 6 years of age, a positive correlation was found between some biomarkers (IGF-1, leptin, and HOMA-IR) and body composition measurements, but not all biomarkers showed such an association.

conclusionsIn this relatively small study, providing a modified, low-protein infant formula during the first months of life did not affect hormonal and metabolic markers during early childhood.

Indexed as

Diet, Protein-RestrictedInfant FormulaBiomarkersBlood GlucoseBreast FeedingChildChild, PreschoolDietary ProteinsFemaleFollow-Up StudiesHumansInfantInfant, NewbornInfant Nutritional Physiological PhenomenaInsulinInsulin-Like Growth Factor Binding ProteinsBiomarkersBlood GlucoseDietary ProteinsInsulinInsulin-Like Growth Factor Binding ProteinsInsulin-Like Growth Factor ILeptinbody compositionhormonal regulationinfant feedingmetabolic markersprotein intake

Identifiers

PMID41540496
PMCPMC13050800

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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 OpenQuestion graph.