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

Safety Issues Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03035721
• Other study ID #: Low protein formula_RCT
• Status: Completed
• Phase: N/A
• First received: January 17, 2017
• Last updated: June 28, 2017
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Infant Nutrition Disorders
• Nutrition Disorders
• Safety Issues

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan	Milano

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Humana Co.Ltd.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	enrollment, 2 months and 4 months
Primary	Evaluate lenght	Lenght (cm) of each baby was measured according standard procedures.	enrollment 2 months and 4 months
Primary	Evaluate head circumference	Head circumference was measured to the nearest 1 mm using non-stretch measuring tape.	enrollment 2 months and 4 months
Primary	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).	enrollment, 2 months and 4 months
Primary	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.	2 months, 4 months
Primary	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.	2 months and 4 months
Primary	Evaluate occurence of adverse events	Adverse events were assessed based on inquires to the parents and on their daily records.	2 months and 4 months
Secondary	Evaluate body mass index (k/m2: weight/length2)	Body mass index [BMI: (Kg/m2)] was assessed for all infants enrolled at each study points.	enrollment, 2 months and 4 months
Secondary	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)].	enrollment, 2 months and 4 months