Evaluation of Different Protein Content of Formulas on Nutrition Status of Infants.
Evaluation of the Impact of Infant Formulas With Different Protein Content on Growth, Gastrointestinal Tolerance, and B-casomorphin Concentration of Infants.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Queretaro
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Querétaro City, Queretaro, Mexico, 76230
- Universidad Autonoma de Queretaro
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: IF-VLP (very low protein)
Participants were exclusively fed with an infant formula containing 1g of protein/dL, 26% alpha lactoalbumin, and 100% A2 casein for 4 months.
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Other: IF-LP (low protein)
Participants were exclusively fed with an infant formula containing 1.3 g of protein/dL, 26% alpha lactoalbumin, 100% A2 casein for 4 months.
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Other: IF-CSP (control standard protein)
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.
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No Intervention: HM (human milk)
Participants were exclusively breastfed
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in weight
Time Frame: Baseline to 4 months of age
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Weight
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Baseline to 4 months of age
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Anthropometry measurements
Time Frame: Baseline, 1, 2 ,3 and 4 months of age
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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.
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Baseline, 1, 2 ,3 and 4 months of age
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Beta-casomorphin 7 concentration
Time Frame: Baseline and at 4 months of age
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Quantification of beta-casomorphin 7 concentration in urine
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Baseline and at 4 months of age
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Number of gastrointestinal events
Time Frame: Baseline, 1, 2, 3, and 4 months
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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).
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Baseline, 1, 2, 3, and 4 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Olga P García, PhD, Universidad Autonoma de Queretaro
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- F-50-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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