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

NCT03513991 | Completed DMC

• 1 other identifier: F-50-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in weight

  Weight

  Baseline to 4 months of age

Secondary Outcomes (3)

• Anthropometry measurements

  Baseline, 1, 2 ,3 and 4 months of age

• Beta-casomorphin 7 concentration

  Baseline and at 4 months of age

• Number of gastrointestinal events

  Baseline, 1, 2, 3, and 4 months

Study Arms (4)

IF-VLP (very low protein)

EXPERIMENTAL

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

Other: Infant formula

IF-LP (low protein)

OTHER

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

Other: Infant formula

IF-CSP (control standard protein)

OTHER

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.

Other: Infant formula

HM (human milk)

NO INTERVENTION

Participants were exclusively breastfed

Interventions

Infant formula OTHER

IF-CSP (control standard protein); IF-LP (low protein); IF-VLP (very low protein)

Eligibility Criteria

• Age: 1 Day - 40 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Queretaro: lead
• NUCITEC S.A. de C.V.: collaborator

Study Sites (1)

Universidad Autonoma de Queretaro

Querétaro City, Querétaro, 76230, Mexico

Location

Related Publications (1)

• Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.

  PMID: 37929831 DERIVED

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Study Officials

• Olga P Garcia, PhD

  Universidad Autonoma de Queretaro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant did not know which formula was assigned. Infant formulas were packed in the same presentation and identified by a number.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 2, 2018
• Study Start: February 15, 2016
• Primary Completion: August 8, 2017
• Study Completion: August 8, 2017
• Last Updated: May 2, 2018

Record last verified: 2018-04

Locations

ME (1)