An interventional study of Low protein formula and Standard protein formula in Safety Issues and Infant Nutrition Disorders, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Completed at 1 site in Italy. Open to participants aged 1 Day to 3 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-29.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Not applicable, Interventional, and Other
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.
275 studies on the registry are indexed under Nutrition Disorders; 31 are open to participants now.
This study's enrollment of 150 is above the median of 117 across 194 interventional studies indexed under Nutrition Disorders.
Browse Nutrition Disorders studies →Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 214 studies on the registry; 71 are open to participants now.
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Exclusion Criteria:
Full term healthy infants randomized to receive a low protein formula for the first 4 months of life
Dietary Supplement: Low protein formula
Full term healthy infants randomized to receive a standard protein formula for the first 4 months of life
Dietary Supplement: Standard protein formula
Breastfed full term healthy infants
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.
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.
Evaluate weight
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).
Time frame: enrollment, 2 months and 4 months
Evaluate lenght
Lenght (cm) of each baby was measured according standard procedures.
Time frame: enrollment 2 months and 4 months
Evaluate head circumference
Head circumference was measured to the nearest 1 mm using non-stretch measuring tape.
Time frame: enrollment 2 months and 4 months
Evaluate body composition (fat mass and fat free mass)
Body composition \[fat mass and fat free mass (g)\]was assessed using an air-displacement plethysmography (PEA POD Infant Body Composition System; COSMED, Italy).
Time frame: enrollment, 2 months and 4 months
Evaluate weight increase
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.
Time frame: 2 months, 4 months
Evaluate gastrointestinal tolerance
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.
Time frame: 2 months and 4 months
Evaluate occurence of adverse events
Adverse events were assessed based on inquires to the parents and on their daily records.
Time frame: 2 months and 4 months
Evaluate body mass index (k/m2: weight/length2)
Body mass index \[BMI: (Kg/m2)\] was assessed for all infants enrolled at each study points.
Time frame: enrollment, 2 months and 4 months
Evaluate z-score
Z-scores values for age were then calculated using the z score calculator provided by WHO \[WHO Anthro (version 3.2.2, January 2011)\].
Time frame: enrollment, 2 months and 4 months
Plan to share: Undecided
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico