Clinical trial NCT03513991: Evaluation of Different Protein Content of Formulas on Nutrition Status of Infants.
Official title: Evaluation of the Impact of Infant Formulas With Different Protein Content on Growth, Gastrointestinal Tolerance, and B-casomorphin Concentration of Infants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth & Development
Formula Feeding of Healthy Full Term Infants
Breast Feeding of Healthy Full Term Infants
Keywords: human milk
infant formula with low protein
alpha lactoalbumin
growth velocity
gastrointestinal events
Lead sponsor: Universidad Autonoma de Queretaro
Sponsor class: OTHER
Collaborators: name: NUCITEC S.A. de C.V.
First posted: 2018-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The exclusively formula-fed infants were randomized to one of three study formulas with different protein profile.

A control group was selected with women that voluntarily chose to exclusively breast feed for at least 4 months.
Primary purpose: OTHER

Brief summary: Human milk (HM) is the gold standard of early infant nutrition. The World Health Organization (WHO) recommend that newborns be exclusively breastfed for the first 6 months of life. It has beed reported that an exclusive breast feeding at 6 months of age range from 10 to 46%. Thus, the intake of infant formulas (IF) is quite widespread, including infants that have less than 6 months that are not receiving breast milk. Most of the commercial IF are cow's milk-based formulas that have a higher concentration of protein than breast milk and have a different protein composition. Commercial IF have a low proportion of alpha lactoalbumin, and A1 β-casein; during its digestion, a β-casomorphin 7 peptide is produced. In addition, it has a high concentration of β-lactoglobulin. Both, β-casomorphin 7 and β-lactoglobulin have been associated with a higher risk of diabetes obesity and allergies. Human β-casein does not produce β-casomorphin 7 during its digestion, it has a high concentration of alpha-lactoalbumin and does not have β-lactoglobulin.

The purpose of this study is to evaluate growth, gastrointestinal tolerance, and β-casomorphin 7 in urine of infants that are exclusively breastfed compared to infants fed three IF with different proteint content.

Detailed description: Developing an IF with A2 β-casein, high proportion of alpha-lactoalbumin and less protein that commercial IF, similar to breast milk (1g/100 mL), could be and important strategy to decrease the risk of diseases. This infant formula was compared with breast milk and two other IF with different protein composition. The three formulas were packed in the same presentation and identified by a number. Mothers voluntarily elected to exclusively breast-feed or formula-feed her newborn. the present study

Infants' mothers were recruited from six health centers from the Health Ministry in Querétaro, México. Directors of each health center authorized the protocol study. The field workers were read and explained the informed consent letter, the objectives, procedures, risks and benefits of the study in detail.

Eligibility criteria: Inclusion Criteria:

* Full-term newborn (≥37 weeks of gestation)
* Birth weight ≥2500 g and ≤4000 g
* Apgar score \> 8
* Infants from birth to 40 days of age at the time of enrollment
* Mothers voluntarily elected to exclusively breast-feed or formula-feed her newborn.

Exclusion Criteria:

* Infants with congenital heart defect, congenital illness or malformations, severe gastrointestinal disease, kidney, liver, central nervous system, or metabolic disease, or born from mothers with gestational diabetes.

Primary outcomes:
measure: Change in weight
timeFrame: Baseline to 4 months of age
Secondary outcomes:
measure: Anthropometry measurements
timeFrame: Baseline, 1, 2 ,3 and 4 months of age
measure: Beta-casomorphin 7 concentration
timeFrame: Baseline and at 4 months of age
measure: Number of gastrointestinal events
timeFrame: Baseline, 1, 2, 3, and 4 months
Other outcomes:
Locations:
city: Querétaro City
country: Mexico
facility: Universidad Autonoma de Queretaro
state: Queretaro
Study officials:
affiliation: Universidad Autonoma de Queretaro
name: Olga P Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
References: