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European Childhood Obesity Project: Early Programming by Infant Nutrition?

NCT00338689 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1678

Last updated 2023-12-11

No results posted yet for this study

Summary

Primary hypothesis to be tested:

Early protein intake predicts infant growth and later risk of childhood obesity.

* Childhood obesity is a major public health problem and is an identified priority concern for the health care. Infants fed formula are more likely to become obese than breastfed infants. The higher protein content of infant formulae, compared with breast milk, could be a causal factor.
* The study will in a multicentre intervention trial on newborn infants investigate whether feeding infant formulae, which differ in their level of milk proteins, can influence the risk of later childhood obesity. The trial will take place in five countries with different habitual total protein intakes to increase the range of protein intakes
* The investigators will study body composition, hormonal status, protein metabolism and anthropometric markers of childhood obesity. The whole cohort will be followed up until age 18 years, to assess the long term impact on the prevalence of obesity.
* The investigators will explore the impact of consumer (parental) attitudes to, and perceptions of, different practices of infant feeding in relation to infant behaviour (satisfaction, crying, sleep duration). This consumer science information will help improve the understanding of consumer (infants and parents) acceptance of and preference for foods that contribute to healthy diets.
* If a relationship between early dietary protein intake and later childhood obesity risk is confirmed, it offers possibilities for the prevention of obesity, for improving advice given to parents and for developing nutritionally improved dietary products for infants.

Conditions

  • Infant Development

Interventions

DIETARY_SUPPLEMENT

Lower protein formula; Higher protein formula

During the intervention phase of the study, which is from inclusion in the study (latest age 2 weeks) until age 12 months, two experimental infant formulae with different protein content are fed to the enrolled infants; Lower protein formula and Higher protein formula. Additional a breastfed observational group without any intervention is included.

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Berthold Koletzko, Prof. · Ludwig-Maximilians-Universitaet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2006-08-31
Completion
2024-12-31

Countries

  • Belgium
  • Germany
  • Italy
  • Poland
  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00338689 on ClinicalTrials.gov