Evaluation of Different Protein Content of Formulas on Nutrition Status of Infants.

Universidad Autonoma de Queretaro

Status: Completed

Conditions: Breast Feeding of Healthy Full Term Infants; Formula Feeding of Healthy Full Term Infants; Growth & Development

Treatments: Other: Infant formula

Study type: Interventional

Funder types: Other

Identifiers

NCT03513991

F-50-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 1 to 40 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 4 patient groups

IF-VLP (very low protein)

Experimental group

Description:

Participants were exclusively fed with an infant formula containing 1g of protein/dL, 26% alpha lactoalbumin, and 100% A2 casein for 4 months.

Treatment:

Other: Infant formula

IF-LP (low protein)

Other group

Description:

Participants were exclusively fed with an infant formula containing 1.3 g of protein/dL, 26% alpha lactoalbumin, 100% A2 casein for 4 months.

Treatment:

Other: Infant formula

IF-CSP (control standard protein)

Other group

Description:

Participants were exclusively fed with an infant formula containing 1.5 g of protein/dL, 50% A1 casein and 50% A2 casein for 4 months.

Treatment:

Other: Infant formula

HM (human milk)

No Intervention group

Description:

Participants were exclusively breastfed