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Feasibility and compliance in a nutritional primary prevention trial in infants at increased risk for type 1 diabetes

S M Virtanen1, S Bärlund, M Salonen

  • 1Nutrition Unit, National Institute for Health and Welfare, Helsinki, Finland.

Acta Paediatrica (Oslo, Norway : 1992)
|December 1, 2010
PubMed

Insights

The pilot study for the Trial to Reduce IDDM in the Genetically at Risk (TRIGR) found that using a hydrolyzed formula in infancy was feasible and compliant. This supports further research into preventing type 1 diabetes in high-risk children.

Area of Science:

  • Pediatric Endocrinology
  • Immunology
  • Nutritional Science

Background:

  • Type 1 diabetes (T1D) incidence is rising globally, particularly in genetically susceptible children.
  • Early life nutrition, specifically infant formula, is being investigated as a potential factor in T1D development.
  • The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) aimed to assess hydrolyzed formula's role in preventing T1D.

Purpose of the Study:

  • To evaluate the feasibility and compliance of a pilot study investigating hydrolyzed formula for preventing type 1 diabetes.
  • To gather data for planning the main TRIGR study, including sample size estimation.

Main Methods:

  • A pilot randomized trial involving 240 children at increased genetic risk for T1D.
  • Dietary assessment using self-administered forms, questionnaires, and food records.
  • Biometric measurements (weight, height) and blood sample collection at multiple time points from birth to 24 months.

Main Results:

  • 84% of subjects used the study formula for at least 2 months, indicating good feasibility.
  • No significant differences in linear growth or weight gain were observed between the hydrolyzed and cow's milk-based formula groups.
  • Higher IgA and IgG antibody levels to cow's milk proteins were found in the cow's milk-based formula group, confirming differential protein exposure.

Conclusions:

  • The pilot study demonstrated the feasibility of the TRIGR protocol and acceptable dietary compliance.
  • Valuable insights were gained for optimizing the design and sample size of the main TRIGR trial.
  • Infant feeding with hydrolyzed formula is a viable strategy to explore for T1D prevention in at-risk populations.
Abstract

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