Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life

Société des Produits Nestlé (SPN)9 sites in 1 country691 target enrollmentOctober 2015

ConditionsHealthy Term Infants

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy Term Infants
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 691
Locations: 9
Primary Endpoint: Growth velocity of formula regimen 1 and 2 versus WHO growth curve
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Growth and metabolic biomarkers of healthy term infants fed formulas with staged protein concentrations over the first year of life

Detailed Description

The overall objective of this study is to assess growth and biomarkers of energy and protein metabolism in healthy term infants fed with two different study formula regimens from birth to 12 months of age and to follow up the infants to 4 years of age.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

July 2022

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy infants will be enrolled in the study provided they meet the following inclusion criteria:
•Having obtained his/her parents' (or his/her legally accepted representative's \[LAR's\]) written informed consent and having evidence of personally signed and dated informed consent document indicating that the infant's parents/LAR have been informed of all pertinent aspects of the study.
•Age ≤ 7 days after birth (date of birth = Day 0)
•Full-term gestational birth (≥ 37 and ≤ 42 weeks)
•Born to mothers with pre-pregnancy body mass index (BMI) ≥ 18.5 and \< 26 kg/m2
•Born to mothers who independently elected, before study enrollment, not to breastfeed (not applicable for infants in the HM-fed comparator group)
•Weight ≥ 2'500 g and ≤ 4'200 g
•Infant's parent(s)/LAR is of legal age of consent, has sufficient command of French language to complete the informed consent and other study documents, and is willing and able to fulfill the requirements of the study protocol
•Infant's parent(s)/LAR is able to be contacted directly by telephone throughout the study

Exclusion Criteria

•Infants who exhibit one or more of the following criteria are excluded from enrollment in the study:
•Born to mothers with hormonal or metabolic disease (e.g. Type-1, Type-2, or gestational diabetes diagnosed according to standardized criteria)
•Born to mothers who smoked \> 10 cigarettes per day during pregnancy
•Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (\> 3 alcoholic beverages per week) during pregnancy
•Cognitive or physical developmental disorders (e.g. malabsorptive disorders such as short bowel syndrome; neurological and congenital disorders that may delay growth such as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down Syndrome, Cri Du Chat; disorders that may lead to obesity such as Prader willi syndrome, Angelman syndrome; other renal, hepatic, pancreatic, or cardiovascular disorders)
•Received radiation therapy (eg. scannography or interventional radiology)
•Participation in any other clinical trial prior to enrollment
•Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures

Outcomes

Primary Outcomes

Growth velocity of formula regimen 1 and 2 versus WHO growth curve

Time Frame: 0-6 months

Compare weight gain velocity (g/day) of each formula-fed group from enrollment to 6 months of age and compare to the World Health Organization (WHO) standards

Growth velocity (g/day) of formula regimen 1 and 2 versus a human milk (HM)-fed comparator group

Time Frame: 0-6 months

Assess the growth velocity of each formula-fed group from enrollment to 6 months of age and compare to growth velocity of a human milk (HM)-fed comparator group.

Secondary Outcomes

Body Composition: Fat free mass density [kg/L] using PeaPod(1-6 months)
Assess the adverse events (AEs) among all study subjects(0-4 years)
Body Composition: Fat free mass [kg] using PeaPod(1-6 months)
Body Composition: Percentage fat mass using PeaPod(1-6 months)
Growth velocity of formula regimen 1 and 2 versus WHO growth curve and versus a human milk (HM)-fed comparator group(0-3 months and 0-12 months)
Other growth parameters z-scores of formula regimen 1 and 2 versus WHO standards and versus a human milk (HM)-fed comparator group(6 and 12 months)
Body Composition: Body mass [kg] using PeaPod(1-6 months)
Assess and compare the child behavior in each group until 4 years of age(0-4 years)
Body Composition: Percentage fat free mass using PeaPod(1-6 months)
Assess and compare the neurodevelopment in each group until 4 years of age(0-4 years)
Body Composition: Body surface area [cm²] using PeaPod(1-6 months)
Body Composition: Body volume [L] using PeaPod(1-6 months)
Body Composition: Fat Free Mass [g] using DEXA(0-3 years)
Compare metabolic biomarkers measures in each formula-fed group to the HM-fed group(0-4 years)
Body Composition: Body density [kg/L] using PeaPod(1-6 months)
Body Composition: Bone Mineral Density [g/cm²] using DEXA(0-3 years)
Body Composition: Total mass [g] using DEXA(0-3 years)
Body Composition: Fat mass [kg] using PeaPod(1-6 months)
Body Composition: Thoracic gas volume (L) using PeaPod(1-6 months)
Body Composition: Bone area [cm²] using DEXA(0-3 years)
Body Composition: Lean mass [g] using DEXA(0-3 years)
Stool microbiota profile, and metabolomics endpoints in each group. Associations between microbiota and metabolomics profiles (serum, urine, and stool).(0-4 years)
Body Composition: Bone Mineral Content [g] using DEXA(0-3 years)
Body Composition: Fat mass [g] using DEXA(0-3 years)
Body Composition: Percentage fat using DEXA(0-3 years)