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

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ClinicalTrials.gov Identifier: NCT03035721
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : June 29, 2017
Sponsor:
Collaborator:
Humana Co.Ltd.
Information provided by (Responsible Party):
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study Description
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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.

Condition or disease Intervention/treatment Phase
Safety Issues Infant Nutrition Disorders Dietary Supplement: Low protein formula Dietary Supplement: Standard protein formula Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Anthropometric and body composition measurements were performed by three medical investigators who were blinded to allocated treatment.
Primary Purpose: Other
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
Study Start Date : June 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : June 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Low protein formula group
Full term healthy infants randomized to receive a low protein formula for the first 4 months of life
 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.
Active Comparator: Standard protein formula group
Full term healthy infants randomized to receive a standard protein formula for the first 4 months of life
 Dietary Supplement: 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.
No Intervention: Breastfeeding group
Breastfed full term healthy infants


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate weight [ Time Frame: 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).

  2. Evaluate lenght [ Time Frame: enrollment 2 months and 4 months ]
    Lenght (cm) of each baby was measured according standard procedures.

  3. Evaluate head circumference [ Time Frame: enrollment 2 months and 4 months ]
    Head circumference was measured to the nearest 1 mm using non-stretch measuring tape.

  4. Evaluate body composition (fat mass and fat free mass) [ Time Frame: 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).

  5. Evaluate weight increase [ Time Frame: 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.

  6. Evaluate gastrointestinal tolerance [ Time Frame: 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.


  7. Evaluate occurence of adverse events [ Time Frame: 2 months and 4 months ]
    Adverse events were assessed based on inquires to the parents and on their daily records.


Secondary Outcome Measures :
  1. Evaluate body mass index (k/m2: weight/length2) [ Time Frame: enrollment, 2 months and 4 months ]
    Body mass index [BMI: (Kg/m2)] was assessed for all infants enrolled at each study points.

  2. Evaluate z-score [ Time Frame: 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)].


Eligibility Criteria
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Ages Eligible for Study:   up to 3 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035721


Locations
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Italy
NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan
Milano, Italy, 20122
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Humana Co.Ltd.
Investigators
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Principal Investigator: Paola Roggero, MD NICU. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy, 20122
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT03035721    
Other Study ID Numbers: Low protein formula_RCT
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Full term healthy infants
Low protein content formula
Safety
Growth
Body composition
Additional relevant MeSH terms:
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Nutrition Disorders
Infant Nutrition Disorders