Clinical trial NCT03035721: Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety Issues
Infant Nutrition Disorders
Keywords: Full term healthy infants
Low protein content formula
Safety
Growth
Body composition
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
Collaborators: name: Humana Co.Ltd.
First posted: 2017-01-30
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* healthy
* singleton
* full-term infants (gestational age 37/0 to 41/6 weeks)
* birth weight adequate for gestational age (\>p10 and \<p90 for gestational age) according to the World Health Organization growth charts.

Exclusion Criteria:

* presence of congenital diseases
* presence of chromosomal abnormalities
* presence of conditions that could interfere with growth, such as brain, metabolic, cardiac and gastrointestinal diseases, perinatal infections.
* being born to mother affected by endocrine and/or metabolic diseases
* having a family history of allergic disease

Primary outcomes:
measure: Evaluate weight
timeFrame: enrollment, 2 months and 4 months
measure: Evaluate lenght
timeFrame: enrollment 2 months and 4 months
measure: Evaluate head circumference
timeFrame: enrollment 2 months and 4 months
measure: Evaluate body composition (fat mass and fat free mass)
timeFrame: enrollment, 2 months and 4 months
measure: Evaluate weight increase
timeFrame: 2 months, 4 months
measure: Evaluate gastrointestinal tolerance
timeFrame: 2 months and 4 months
measure: Evaluate occurence of adverse events
timeFrame: 2 months and 4 months
Secondary outcomes:
measure: Evaluate body mass index (k/m2: weight/length2)
timeFrame: enrollment, 2 months and 4 months
measure: Evaluate z-score
timeFrame: enrollment, 2 months and 4 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan
Study officials:
affiliation: NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy, 20122
name: Paola Roggero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liotto N, Orsi A, Menis C, Piemontese P, Morlacchi L, Condello CC, Gianni ML, Roggero P, Mosca F. Clinical evaluation of two different protein content formulas fed to full-term healthy infants: a randomized controlled trial. BMC Pediatr. 2018 Feb 13;18(1):59. doi: 10.1186/s12887-018-1046-6.