Safety Issues Clinical Trial
Official title:
Clinical Evaluation of a Low Protein Content Formula Fed to Full Term Healthy Infants in the First Months of Life: a Randomized Controlled Trial
This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects.
Infants were randomized to receive either a standard protein formula or a low-protein
formula. The composition of the low-protein formula vs the standard formula was: energy (65
vs. 68 kcal/100 mL), protein (1.2 vs. 1.7 g/100 mL).
To investigate the safety of the low-protein formula without any bias, a 4-month
intervention period was selected during which the infants were fed only formula.
Anthropometric parameters (weight, length, and head circumference) and body composition were
assessed at enrollment, at 2 and 4 months' of age. Parents were asked to keep a diary on the
occurrence of gastrointestinal symptoms or any other symptoms and were contacted every two
weeks either by clinic visits or phone calls.
The reference group was constituted by a cohort of healthy, exclusively breastfed, full-term
infants.
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