Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT
- Conditions
- Safety IssuesInfant Nutrition Disorders
- Interventions
- Dietary Supplement: Low protein formulaDietary Supplement: Standard protein formula
- Registration Number
- NCT03035721
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low protein formula group Low protein formula Full term healthy infants randomized to receive a low protein formula for the first 4 months of life Standard protein formula group Standard protein formula Full term healthy infants randomized to receive a standard protein formula for the first 4 months of life
- Primary Outcome Measures
Name Time Method Evaluate weight enrollment, 2 months and 4 months Weight (g) of each baby was measured on an electronic scale accurate to 0.1 g (PEA POD Infant Body Composition System; Cosmed, Concord, CA, US). Body length was measured to the nearest 1 mm on a Harpenden neonatometer (Holtain, Crymych, UK).
Evaluate lenght enrollment 2 months and 4 months Lenght (cm) of each baby was measured according standard procedures.
Evaluate head circumference enrollment 2 months and 4 months Head circumference was measured to the nearest 1 mm using non-stretch measuring tape.
Evaluate gastrointestinal tolerance 2 months and 4 months 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 occurrence of spitting up, vomiting and colic, defined as intermittent attacks of abdominal pain when the baby screamed and drew up his/her legs but was well between episodes, was recorded. Colic was further classified as severe if the episodes were more than twice per day. Daily frequency of stool passage was also collected.Evaluate occurence of adverse events 2 months and 4 months Adverse events were assessed based on inquires to the parents and on their daily records.
Evaluate body composition (fat mass and fat free mass) enrollment, 2 months and 4 months Body composition \[fat mass and fat free mass (g)\]was assessed using an air-displacement plethysmography (PEA POD Infant Body Composition System; COSMED, Italy).
Evaluate weight increase 2 months, 4 months Weight increase (g/day) was calculated as a change in body weight from weight at study enrollment divided by the time interval from enrolment to the assessment at 4 months Fat mass (g/day) and fat free mass (g/day) increases were also calculated.
- Secondary Outcome Measures
Name Time Method Evaluate body mass index (k/m2: weight/length2) enrollment, 2 months and 4 months Body mass index \[BMI: (Kg/m2)\] was assessed for all infants enrolled at each study points.
Evaluate z-score enrollment, 2 months and 4 months Z-scores values for age were then calculated using the z score calculator provided by WHO \[WHO Anthro (version 3.2.2, January 2011)\].
Trial Locations
- Locations (1)
NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan
🇮🇹Milano, Italy