Evidence map›Paper›PMID 38906178›Full record

Trial reportThe Journal of nutrition2024

High Concentrations of Immunoglobulin G Against Cow Milk Proteins and Frequency of Cow Milk Consumption Are Associated With the Development of Islet Autoimmunity and Type 1 Diabetes-The Trial to Reduce Insulin-dependent Diabetes Mellitus (IDDM) in the Genetically at Risk (TRIGR) Study.

Sari Niinistö, David Cuthbertson, Maija E Miettinen, Leena Hakola, Anita Nucci, Tuuli E Korhonen, Heikki Hyöty, Jeffrey P Krischer, Outi Vaarala, Mikael Knip and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of nutrition, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00179777 (TRIGR - Trial to Reduce IDDM in the Genetically at Risk), which is not on this 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.

NCT00179777 nacompletednot on this map

TRIGR - Trial to Reduce IDDM in the Genetically at Risk

TypeinterventionalSponsorUniversity of HelsinkiRan2002 to 2017Enrolled5,156ConditionsDiabetes Mellitus, Type 1ArmsHydrolysed infant formula, Nonhydrolysed infant formula
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
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

13 authors.

Sari NiinistöDepartment of Public Health and Welfare, Finnish Institute for Health and Welfare, Helsinki, Finland. Electronic address: sari.niinisto@thl.fi.
David CuthbertsonHealth Informatics Institute, Morsani College of Medicine, University of South Florida, Tampa, FL, United States.
Maija E MiettinenDepartment of Public Health and Welfare, Finnish Institute for Health and Welfare, Helsinki, Finland.
Leena HakolaUnit of Health Sciences, Faculty of Social Sciences, Tampere University, Tampere, Finland; Tampere University Hospital, Wellbeing Services County of Pirkanmaa, Tampere, Finland.
Anita NucciDepartment of Nutrition, Georgia State University, Atlanta, GA, United States.
Tuuli E KorhonenDepartment of Public Health and Welfare, Finnish Institute for Health and Welfare, Helsinki, Finland.
Heikki HyötyFaculty of Medicine and Health Technology, Tampere University, Tampere, Finland; Fimlab Laboratories, Pirkanmaa Hospital District, Tampere, Finland.
Jeffrey P KrischerHealth Informatics Institute, Morsani College of Medicine, University of South Florida, Tampa, FL, United States.
Outi VaaralaResearch Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Helsinki, Finland.
Mikael KnipResearch Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Helsinki, Finland; Pediatric Research Center, New Children's Hospital, Helsinki University Hospital, Helsinki, Finland; Department of Pediatrics, Tampere University Hospital, Tampere, Finland.
Erkki SavilahtiPediatric Research Center, New Children's Hospital, Helsinki University Hospital, Helsinki, Finland.
Suvi M VirtanenDepartment of Public Health and Welfare, Finnish Institute for Health and Welfare, Helsinki, Finland; Unit of Health Sciences, Faculty of Social Sciences, Tampere University, Tampere, Finland; Department of Pediatrics, Tampere University Hospital, Tampere, Finland; Center for Child Health Research, Tampere University and Tampere University Hospital, Tampere, Finland.
TRIGR Investigators

Funding

Trial to Reduce IDDM in the Genetically at Risk StudyU01HD040364 · NICHD · UNIVERSITY OF HELSINKI · PI KNIP, MIKAEL · 2001 to 2015
$32.7M
Trial to Reduce IDDM in the Genetically at Risk: A Nutritional primary preventionU01HD042444 · NICHD · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BECKER, DOROTHY J · 2001 to 2015
$24.4M
Trial to Reduce IDDM in the Genetically at Risk (TRIGR) Data Management UnitR01HD051997 · NICHD · UNIVERSITY OF SOUTH FLORIDA · PI KRISCHER, JEFFREY P · 2016 to 2018
$2.3M
Effect of early diet and virus infections on immune regulation and the development islet autoimmunity -Trial to Reduce IDDM in the Genetically at Risk (TRIGR)DP3DK106918 · NIDDK · NATIONAL INSTITUTE FOR HEALTH & WELFARE · PI VIRTANEN, SUVI MIRJAMI · 2015 to 2015
$1.1M
CIHRNICHD NIH HHS R01 HD051997NICHD NIH HHS U01 HD040364NICHD NIH HHS U01 HD042444NIDDK NIH HHS DP3 DK106918
6 · The paper itself

Abstract

backgroundThe Trial to Reduce IDDM in the Genetically at Risk (TRIGR) (NCT00179777) found no difference type 1 diabetes risk between hydrolyzed and regular infant formula. However, cow milk consumption during childhood is consistently linked to type 1 diabetes risk in prospective cohort studies.

objectivesOur primary aim was to study whether humoral immune responses to cow milk and cow milk consumption are associated with type 1 diabetes in TRIGR children.

methodsTRIGR comprised 2159 children with genetic susceptibility to type 1 diabetes born between 2002 and 2007 in 15 countries. Children were randomly assigned into groups receiving extensively hydrolyzed casein or a regular cow milk formula and followed up until age 10 y. Type 1 diabetes-related autoantibodies and antibodies to cow milk proteins were analyzed. Infant formula intake was measured by structured dietary interviews and milk consumption with a food frequency questionnaire. Associations of milk antibodies and milk consumption with risk to develop type 1 diabetes were analyzed using Cox survival model.

resultsCow milk antibody concentrations both in cord blood [hazards ratio (HR) for islet autoimmunity: 1.30; 95% CI: 1.05, 1.61; HR for type 1 diabetes: 1.32; 95% CI: 1.02, 1.71] and longitudinally from birth to 3 years (HR for islet autoimmunity: 1.39; 95% CI: 1.07, 1.81; HR for type 1 diabetes: 1.43; 95% CI: 1.04, 1.96) were associated with increased risk of developing type 1 diabetes. The amount of regular infant formula was associated with reduced islet autoimmunity risk in the regular infant formula group (HR: 0.92; 95% CI: 0.85, 0.99). Furthermore, frequent liquid milk consumption after infancy was associated with increased risk of islet autoimmunity or type 1 diabetes.

conclusionsElevated cow milk antibody concentrations and high consumption of liquid milk after infancy are related to type 1 diabetes development in children with an increased genetic susceptibility to type 1 diabetes. Enhanced antibody concentrations to cow milk may provide a biomarker of immune system prone to develop islet autoimmunity. This trial was registered at clinicaltrials.gov as NCT00179777.

Indexed as

AutoimmunityDiabetes Mellitus, Type 1Immunoglobulin GInfant FormulaIslets of LangerhansMilkMilk ProteinsAnimalsAutoantibodiesCaseinsCattleChildChild, PreschoolDietFemaleFollow-Up StudiesAutoantibodiesCaseinsImmunoglobulin GMilk Proteinschildrencow milkcow milk antibodiescow milk–based infant formulaextensively hydrolyzed infant formulainfantsislet autoimmunitytype 1 diabetes

Identifiers

PMID38906178
PMCPMC11375457

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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.