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

NCT03035721 | Completed

• 1 other identifier: Low protein formula_RCT
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety Issues; Infant Nutrition Disorders

Keywords

Full term healthy infants; Low protein content formula; Safety; Growth; Body composition

Outcome Measures

Primary Outcomes (7)

• 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

• Evaluate lenght

  Lenght (cm) of each baby was measured according standard procedures.

  enrollment 2 months and 4 months

• Evaluate head circumference

  Head circumference was measured to the nearest 1 mm using non-stretch measuring tape.

  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).

  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.

  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.

  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.

  2 months and 4 months

Secondary Outcomes (2)

• Evaluate body mass index (k/m2: weight/length2)

  enrollment, 2 months and 4 months

• Evaluate z-score

  enrollment, 2 months and 4 months

Study Arms (3)

Low protein formula group

EXPERIMENTAL

Full term healthy infants randomized to receive a low protein formula for the first 4 months of life

Dietary Supplement: Low protein formula

Standard protein formula group

ACTIVE COMPARATOR

Full term healthy infants randomized to receive a standard protein formula for the first 4 months of life

Dietary Supplement: Standard protein formula

Breastfeeding group

NO INTERVENTION

Breastfed full term healthy infants

Interventions

Low protein formula DIETARY_SUPPLEMENT

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.

Low protein formula group

Standard protein formula DIETARY_SUPPLEMENT

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.

Standard protein formula group

Eligibility Criteria

• Age: 1 Day - 3 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead
• Humana Co.Ltd.: collaborator

Study Sites (1)

NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan

Milan, 20122, Italy

Location

Related Publications (1)

• 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.

  PMID: 29439736 DERIVED

MeSH Terms

Conditions

Infant Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Paola Roggero, MD

  NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy, 20122

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Anthropometric and body composition measurements were performed by three medical investigators who were blinded to allocated treatment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 30, 2017
• Study Start: June 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 29, 2017

Record last verified: 2017-01

Locations

IT (1)