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

Growth & Development Clinical Trial

Official title:

Evaluation of the Impact of Infant Formulas With Different Protein Content on Growth, Gastrointestinal Tolerance, and B-casomorphin Concentration of Infants.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03513991
• Other study ID #: F-50-02
• Status: Completed
• Phase: N/A
• Start date: February 15, 2016
• Est. completion date: August 8, 2017

Study information

• Verified date: April 2018
• Source: Universidad Autonoma de Queretaro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 8, 2017
• Est. primary completion date: August 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 40 Days

Eligibility

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.

Related Conditions & MeSH terms

• Breast Feeding of Healthy Full Term Infants
• Formula Feeding of Healthy Full Term Infants
• Growth & Development

Intervention

Other:
• Infant formula

Locations

Country	Name	City	State
Mexico	Universidad Autonoma de Queretaro	Querétaro City	Queretaro

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Autonoma de Queretaro	NUCITEC S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Weight	Baseline to 4 months of age
Secondary	Anthropometry measurements	Measurements will include length and head circumference, and together with the primary outcome of weight, will be used to calculate z-scores using WHO Growth Standards.	Baseline, 1, 2 ,3 and 4 months of age
Secondary	Beta-casomorphin 7 concentration	Quantification of beta-casomorphin 7 concentration in urine	Baseline and at 4 months of age
Secondary	Number of gastrointestinal events	Gastrointestinal events will be recorded by the mothers. These events include: constipation, diarrhea, regurgitation, vomit, reflux, colic, constant crying, and stool consistency and color, using previously reported scales (Bekkali et al, 2009; Trabulsi, 2011).	Baseline, 1, 2, 3, and 4 months