Infant Nutrition Disorders, Safety Issues
Conditions
Keywords
Full term healthy infants, Low protein content formula, Safety, Growth, Body composition
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.
Interventions
DIETARY_SUPPLEMENTLow 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_SUPPLEMENTStandard 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.
Sponsors
Humana Co.Ltd.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Anthropometric and body composition measurements were performed by three medical investigators who were blinded to allocated treatment.
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 \[WHO Anthro (version 3.2.2, January 2011)\]. |
| 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. |
Countries
Italy
Outcome results
None listed