Insulin-free Cow Milk Formula in Prevention of Type 1 Diabetes Associated Autoimmunity - FINDIA Pilot Study

Pilot Study of Dietary Prevention of Type 1 Diabetes Associated Beta-cell Autoimmunity in Children at Genetic Risk

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01055080

Acronym

FINDIA

Enrollment

987

Registered

2010-01-25

Start date

2002-05-31

Completion date

2009-12-31

Last updated

2010-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta-cell Autoimmunity

Keywords

type 1 diabetes, beta-cell autoantibodies, cow's milk formula, bovine insulin

Brief summary

The purpose of this study is to determine whether weaning to whey-based hydrolysed formula or essentially bovine insulin free whey-based FINDIA formula instead of standard cow's milk based formula is effective in the prevention of type 1 diabetes associated beta-cell autoimmunity in children at genetic risk of type 1 diabetes.

Interventions

DIETARY_SUPPLEMENTCow's milk formula

Weaning to three different type of cow's milk formula when breast milk is not available during the first 6 months of life

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

* HLA-conferred genetic susceptibility for type 1 diabetes

Exclusion criteria

* Pre-term, maternal diabetes with insulin treatment

Design outcomes

Primary

Measure	Time frame
Beta-cell autoantibodies	3,6,12,24,36,48,60,72 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026