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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Current Primary Outcome:

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

    Parents were asked to keep a diary on the oc

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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.
    • 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)].


    Original Secondary Outcome: Same as current

    Information By: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    Dates:
    Date Received: January 17, 2017
    Date Started: January 2017
    Date Completion: April 2017
    Last Updated: January 25, 2017
    Last Verified: January 2017