Growth & DevelopmentNCT03513991
Evaluation of Different Protein Content of Formulas on Nutrition Status of Infants.
A study testing Infant formula in people with Growth & Development and Formula Feeding of Healthy Full Term Infants, run by Universidad Autonoma de Queretaro at 1 site in Mexico.
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%. Read more about this study
- Who is it for?
- Ages 1 day to 40 daysHealthy volunteers can take part
- Conditions the study is for
- Growth & Development, Formula Feeding of Healthy Full Term Infants, Breast Feeding of Healthy Full Term Infants
- What is being tested?
- Infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 15 Feb 2016to 8 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 40 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Mexico1 site
Universidad Autonoma de Queretaro
Querétaro City, Querétaro, 76230
About this study
Official title: 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.
Read the 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.
- Conditions
- Growth & Development, Formula Feeding of Healthy Full Term Infants, Breast Feeding of Healthy Full Term Infants
- Being tested
- Infant formula
- Keywords
- human milk, infant formula with low protein, alpha lactoalbumin, growth velocity, gastrointestinal events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formulaOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Infant formula |
| HM (human milk) | No intervention | Participants were exclusively breastfed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Weight
Measured: Baseline to 4 months of age
Secondary outcomes (3)
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.
Measured: Baseline, 1, 2 ,3 and 4 months of age
Beta-casomorphin 7 concentration
Quantification of beta-casomorphin 7 concentration in urine
Measured: Baseline and at 4 months of age
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).
Measured: Baseline, 1, 2, 3, and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start15 Feb 2016
- Primary completion8 Aug 2017
- Study completion8 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth & DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Queretaro
- Sponsor type
- University, hospital or other
- Collaborators
- NUCITEC S.A. de C.V.
- Responsible party
- Principal investigator, Olga Patricia García Obregon, Universidad Autonoma de Queretaro
- Investigators
- Olga P Garcia, PhD, Principal investigator, Universidad Autonoma de Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513991
- Sponsor's protocol ID
- F-50-02
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2018
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37929831
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Infant Formulas With Different Protein Content on Growth, Gastrointestinal Tolerance, and B-casomorphin Concentration of Infants.
- ClinicalTrials.gov ID
- NCT03513991
- Acronym / sponsor ID
- F-50-02
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Autonoma de QueretaroUniversity, hospital or other
- Collaborators
- NUCITEC S.A. de C.V.
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 8 Aug 2017 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| IF-VLP (very low protein) | Experimental | Other: Infant formulaParticipants were exclusively fed with an infant formula containing 1g of protein/dL, 26% alpha lactoalbumin, and 100% A2 casein for 4 months. |
| IF-LP (low protein) | Other | Other: Infant formulaParticipants were exclusively fed with an infant formula containing 1.3 g of protein/dL, 26% alpha lactoalbumin, 100% A2 casein for 4 months. |
| IF-CSP (control standard protein) | Other | Other: Infant formulaParticipants were exclusively fed with an infant formula containing 1.5 g of protein/dL, 50% A1 casein and 50% A2 casein for 4 months. |
| HM (human milk) | No intervention | –Participants were exclusively breastfed |
Who may qualify
- Ages
- 1 day to 40 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant formula | Other | IF-CSP (control standard protein), IF-LP (low protein), IF-VLP (very low protein) |
Primary outcome
Change in weight
Time frame: Baseline to 4 months of age
Weight
3 secondary outcomes
Anthropometry measurements
Time frame: Baseline, 1, 2 ,3 and 4 months of age
Beta-casomorphin 7 concentration
Time frame: Baseline and at 4 months of age
Number of gastrointestinal events
Time frame: Baseline, 1, 2, 3, and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Derived from this study: PubMed 37929831Gonzalez-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga P Garcia, PhD principal investigator
Universidad Autonoma de Queretaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant formula in people with Growth & Development and Formula Feeding of Healthy Full Term Infants, run by Universidad Autonoma de Queretaro at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: Baseline to 4 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03513991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.