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Metabolic and hormonal serum markers in early childhood: Follow‐up of a randomized controlled trial during infancy evaluating a modified, low‐protein infant formula

Year: 2026
Type: article
Study design: Clinical Trial
Abstract: OBJECTIVES: High protein intake during infancy has been linked to accelerated weight gain and increased obesity risk. This study aimed to examine the effects of a low-protein formula during the first 6 months of life on blood metabolic and hormonal markers during early childhood. METHODS: Formula-fed infants (<45 days) were randomized to receive either a low-protein formula with modified amino acid composition (mLP; n = 90; 1.7 g protein/100 kcal) or a control formula (CTRL; n = 88; 2.1 g protein/100 kcal) until 6 months of age. Breastfed infants served as a reference group (n = 67). Blood samples were collected in cooperating subjects at 1, 2, and 6 years. We measured insulin-like growth factor-1 (IGF-1), IGF-binding proteins (BPs), leptin, glucose, and insulin, and calculated Homeostatic-Model-Assessment-of-Insulin-Resistance (HOMA-IR). Data were analyzed using linear mixed models and linear regression, adjusting for confounders. In addition, results were correlated to priorly published body composition measurement. RESULTS: Venous blood was collected from 87 (36%), 77 (31%), and 63 (26%) participants at ages 1, 2, and 6 years, respectively. No differences were found in metabolic markers between the formula groups or compared to the breastfed group at any time point. Furthermore, at 6 years of age, a positive correlation was found between some biomarkers (IGF-1, leptin, and HOMA-IR) and body composition measurements, but not all biomarkers showed such an association. CONCLUSIONS: In this relatively small study, providing a modified, low-protein infant formula during the first months of life did not affect hormonal and metabolic markers during early childhood.
Language: English
Field: Nursing
Open Access status: hybrid
Estimated APC paid: $3,780
OpenAlex ID: W7124428417
FWCI:
Cites: 22
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