Randomised controlled trialcited by the Tayebat archiveabstract only checked A-DRY-12 standard review
Large infant trial: avoiding intact cow's milk protein did not prevent type 1 diabetes
Effect of Hydrolyzed Infant Formula vs Conventional Formula on Risk of Type 1 Diabetes: The TRIGR Randomized Clinical Trial.
Overview
Writing Group for the TRIGR Study Group et al.. JAMA 2018 · PMID 29297078 · DOI 10.1001/jama.2017.19826
Type 1 diabetes in 8.4% vs 7.6%; no significant difference.
Does the study support the specific claim? No · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Test hydrolysed formula for T1D prevention.
- How was the study done?
RCT, 11.5-year follow-up.
- How many people, animals or samples were studied?
2,159 at-risk infants.
- What was actually found?
No benefit.
- How large was the observed effect?
HR 1.1 (0.8-1.5).
- What do the results mean in everyday life?
Cow's milk formula did not raise T1D risk in this test.
- What are the study's limitations?
Specific population.
- What does it say about Elawady's specific claim?
Contradicts the implied claim.
- Do the results apply to Germany and Europe?
Includes Europe.
- What can explicitly not be concluded from this study?
Anything about adult dairy.
Scientific in-depth review
1. Full reference
- Authors
- Writing Group for the TRIGR Study Group, Knip M, Åkerblom HK, Al Taji E, Becker D, Bruining J, Castano L, Danne T, de Beaufort C, Dosch HM, Dupre J, Fraser WD, Howard N, Ilonen J, Konrad D, Kordonouri O, Krischer JP, Lawson ML, Ludvigsson J, Madacsy L, Mahon JL, Ormisson A, Palmer JP, Pozzilli P, Savilahti E, Serrano-Rios M, Songini M, Taback S, Vaarala O, White NH, Virtanen SM, Wasikowa R
- Journal
- JAMA
- Year
- 2018
- Identifier
- PMID 29297078 DOI 10.1001/jama.2017.19826 · PMC5833549
- Verification
- verified – PubMed E-utilities efetch, 2026-10-25
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Grants listed in PubMed: CIHR, NCATS NIH HHS, NICHD NIH HHS, NIDDK NIH HHS
2. Research question
Does weaning to extensively hydrolysed casein formula reduce type 1 diabetes in at-risk infants?
3. Study design and population
- Study design
- Randomised controlled trial – International double-blind randomised trial (TRIGR).
- Population
Infants with HLA-conferred susceptibility and a first-degree relative with T1D
- Country
15 countries (78 centres)
- Period
2002-2007 recruitment; follow-up to Feb 2017 (median 11.5 y)
- Sample size
2,159 infants
- Inclusion and exclusion criteria
HLA risk genotype and first-degree relative with T1D.
4. Methods and endpoints
- Exposure / intervention
Extensively hydrolysed casein formula
- Comparator
Conventional cow's milk formula with 20% hydrolysate
- Endpoints
Type 1 diabetes (WHO criteria); age at diagnosis; adverse events.
- Statistical methods
Adjusted Cox HR with centre random effect.
5. Actual results
- Results
T1D 8.4% (hydrolysate, n=91) vs 7.6% (conventional, n=82); difference 0.8% (-1.6% to 3.2%); adjusted HR 1.1 (0.8-1.5), P=.46; median age at diagnosis 6.0 vs 5.8 years.
- Absolute risks
8.4% vs 7.6% cumulative incidence.
- Authors' conclusion
Hydrolysed formula did not reduce T1D incidence; findings do not support revising dietary recommendations for at-risk infants.
6. Strengths
- Large multinational RCT
- Long follow-up
- Double-blind
7. Weaknesses
- Specific high-risk infant population
- Compares formula types, not dairy vs no dairy in adults
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- low
- Rationale
Well-conducted RCT; 80.8% completed.
9. Assessment of the statistical interpretation
Null result with reasonably narrow CI.
10. Relevance to the specific claim
Contradicts the implied C-DRY-12.
11. Independent contrary findings
Itself.
12. Transferability to Germany and Europe
Includes European centres.
13. Overall methodological judgement
High-quality null trial.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | low |
| Precision of results | moderate |
| Directness | very indirect |
| Reproducibility | unknown |
| Consistency with the overall evidence | unknown |
| Regional transferability | moderate |
| Adequacy of the interpretation (by the archive) | not supported by the study |
14. Open questions
None for this question.
15. Linked fact checks
- Dairy contributes to further diseases cited in the archive bibliography: non-Hodgkin lymphoma, type 1 diabetes (cow's milk proteins in infancy) and galactose-induced skin ageing. – Studies contradicting or limiting the claim
Use by the Tayebat archive
Note: according to the archive, the studies were compiled by the archive operators. Whether Dr. Elawady himself cited this study is not established.
- What the archive says about the study
Listed in bibliography without interpretation.
- A. What was actually studied?
Hydrolysed vs conventional cow's milk formula and T1D.
- B. What did the authors find?
No difference (HR 1.1).
- C. What conclusions do the authors themselves draw?
No reduction in T1D; no need to change recommendations.
- D. What does the archive derive from it?
Implied as dairy-harm evidence by inclusion.
- E. Is this derivation scientifically justified?
Not justified: the trial is null and contradicts a cow's milk protein-T1D link.
- Adequacy of the interpretation (by the archive)
- not supported by the study