Lower protein content in infant formula reduces BMI and obesity risk at school age: follow-up of a randomized trial
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Updated: May 2, 2026

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Published on: July 29, 2020
Martina Weber1, Veit Grote, Ricardo Closa-Monasterolo
1Division of Metabolic and Nutritional Medicine, Dr. von Hauner Children's Hospital, University of Munich Medical Centre, Munich, Germany (MW, VG, and BK); the Paediatrics Research Unit, Universitat Rovira i Virgili, Reus, Spain (RC-M and JE); Centre Hospitalier Chrétien St Vincent, Liège-Rocourt, Belgium (J-PL); the Department of Paediatrics, University Children's Hospital Queen Fabiola, Université Libre de Bruxelles, Brussels, Belgium (ED); the Department of Paediatrics, San Paolo Hospital, University of Milan, Milan, Italy (MG and EV); the Children's Memorial Health Institute, Neonatal Intensive Care Unit, Warsaw, Poland (DG); and the Children's Memorial Health Institute, Department of Gastroenterology, Hepatology and Eating Disorders, Warsaw, Poland (PS).
Background:
Early nutrition is recognized as a target for the effective prevention of childhood obesity. Protein intake was associated with more rapid weight gain during infancy-a known risk factor for later obesity.
Objective:
We tested whether the reduction of protein in infant formula reduces body mass index (BMI; in kg/m(2)) and the prevalence of obesity at 6 y of age.
Design:
The Childhood Obesity Project was conducted as a European multicenter, double-blind, randomized clinical trial that enrolled healthy infants born between October 2002 and July 2004. Formula-fed infants (n = 1090) were randomly assigned to receive higher protein (HP)- or lower protein (LP)-content formula (within recommended amounts) in the first year of life; breastfed infants (n = 588) were enrolled as an observational reference group. We measured the weight and height of 448 (41%) formula-fed children at 6 y of age. BMI was the primary outcome.
Results:
HP children had a significantly higher BMI (by 0.51; 95% CI: 0.13, 0.90; P = 0.009) at 6 y of age. The risk of becoming obese in the HP group was 2.43 (95% CI: 1.12, 5.27; P = 0.024) times that in the LP group. There was a tendency for a higher weight in HP children (0.67 kg; 95% CI: -0.04, 1.39 kg; P = 0.064) but no difference in height between the intervention groups. Anthropometric measurements were similar in the LP and breastfed groups.
Conclusions:
Infant formula with a lower protein content reduces BMI and obesity risk at school age. Avoidance of infant foods that provide excessive protein intakes could contribute to a reduction in childhood obesity. This trial was registered at clinicaltrials.gov as NCT00338689.
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