NCT03035721

Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT

Clinical Evaluation of a Low Protein Content Formula Fed to Full Term Healthy Infants in the First Months of Life: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 1 Day – 3 Weeks
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Safety Issues
• Infant Nutrition Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low protein formula	Infants were enrolled to receive low protein formula (energy: 65 kcal/100 mL, protein: 1.2 g/100 mL, protein-to-energy ratio:1.9 g/100 kcal, carbohydrates: 8 g/100 mL, fat: 3.1 g/100 mL) for the firsts 4 months of life.
DIETARY_SUPPLEMENT	Standard protein formula	Infants were enrolled to receive standard protein formula (energy: 68 kcal/100 mL, protein: 1.7 g/100 mL, protein-to-energy ratio:2.5 g/100 kcal, carbohydrates: 7.1 g/100 mL, fat: 3.5 g/100 mL) for the firsts 4 months of life.

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-01-01
• Completion: 2016-06-01
• First posted: 2017-01-30
• Last updated: 2017-06-29

Locations

1 site across 1 country: Italy