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)691 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

691

Conditions

Healthy Term Infants

Interventions

Formula regimen 1DIETARY_SUPPLEMENT

Formula regimen 2DIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 0 DaysMax age: 7 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Healthy infants will be enrolled in the study provided they meet the following inclusion criteria: 1. 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. 2. Age ≤ 7 days after birth (date of birth = Day 0) 3. Full-term gestational birth (≥ 37 and ≤ 42 weeks) 4. Born to mothers with pre-pregnancy body mass index (BMI) ≥ 18.5 and \< 26 kg/m2 5. Born to mothers who independently elected, before study enrollment, not to breastfeed (not applicable for infants in the HM-fed comparator group) 6. Weight ≥ 2'500 g and ≤ 4'200 g 7. 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 8. 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: 1. Born to mothers with hormonal or metabolic disease (e.g. Type-1, Type-2, or gestational diabetes diagnosed according to standardized criteria) 2. Born to mothers who smoked \> 10 cigarettes per day during pregnancy 3. Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (\> 3 alcoholic beverages per week) during pregnancy 4. 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) 5. Received radiation therapy (eg. scannography or interventional radiology) 6. Participation in any other clinical trial prior to enrollment 7. Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures

Locations (9)

CHU Pellegrin

Bordeaux, Bordeaux, France

Hospices Civils de LYON - Hôpital Femme Mère Enfant de Bron

Bron, France

Centre Hospitalier Régional Universitaire de Lille

Lille, France

Hospices Civils de LYON - Hopital de La Croix Rousse

Outcomes

Primary Outcomes

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

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

Time frame: 0-6 months

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

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.

Time frame: 0-6 months

Secondary Outcomes

Growth velocity of formula regimen 1 and 2 versus WHO growth curve and versus a human milk (HM)-fed comparator group

Assess the growth velocity of each formula-fed group from enrollment to 3 months, and from enrollment to 12 months, and compare to both WHO standards and to the HM-fed comparator group.

Time frame: 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

Weight-for-length, weight-for-age, length-for-age, head circumference-for-age, and BMI-for-age z-scores

Time frame: 6 and 12 months

Compare metabolic biomarkers measures in each formula-fed group to the HM-fed group

Assess and compare metabolic biomarkers in each formula-fed group to the HM-fed group. Here is the list of metabolic biomarkers that will be measured: free and total IGF-1, IGF-binding protein 2, IGF-binding protein 3, C-peptide, insulin, glucose, leptin, adiponectin, ghrelin in all subjects and complete amino acid profile in subset

Time frame: 0-4 years

Assess the adverse events (AEs) among all study subjects

Data from ClinicalTrials.gov

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Assistance Publique-Hôpitaux de Marseille, Hôpital de la Conception

Marseille, France

Assistance Publique-Hôpitaux de Marseille, Hôpital NORD

Marseille, France

Centre Hospitalier du Belvédère

Mont-Saint-Aignan, France

CHU de Nancy - Hôpital Brabois

Nancy, France

CHU - Hôpitaux de ROUEN

Rouen, France

Assess the type, incidence, severity, seriousness, and relationship to study formulas of AEs among study subjects.

Time frame: 0-4 years

Assess and compare the child behavior in each group until 4 years of age

Neurodevelopment will be assessed by parental ratings of child development using validated measures Ages and Stages Questionnaire (ASQ)

Time frame: 0-4 years

Assess and compare the neurodevelopment in each group until 4 years of age

Neurodevelopment will be assessed by tests of child development using validated Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV)

Time frame: 0-4 years

Body Composition: Body density [kg/L] using PeaPod

Body density in kg/L will be assessed using PeaPod

Time frame: 1-6 months

Body Composition: Body mass [kg] using PeaPod

Body mass in kg will be assessed using PeaPod

Time frame: 1-6 months

Body Composition: Body surface area [cm²] using PeaPod

Body surface area in cm² will be assessed using PeaPod

Time frame: 1-6 months

Body Composition: Body volume [L] using PeaPod

Body volume in L will be assessed using PeaPod

Time frame: 1-6 months

Body Composition: Fat free mass [kg] using PeaPod

Fat free mass in kg will be assessed using PeaPod

Time frame: 1-6 months

Body Composition: Fat free mass density [kg/L] using PeaPod

Fat free mass density in kg/L will be assessed using PeaPod

Time frame: 1-6 months

Body Composition: Fat mass [kg] using PeaPod

Fat mass in kg will be assessed using PeaPod

Time frame: 1-6 months

Body Composition: Percentage fat free mass using PeaPod

Percentage fat free mass will be assessed using PeaPod

Time frame: 1-6 months

Body Composition: Percentage fat mass using PeaPod

Percentage fat mass will be assessed using PeaPod

Time frame: 1-6 months

Body Composition: Thoracic gas volume (L) using PeaPod

Thoracic gas volume in L will be assessed using PeaPod

Time frame: 1-6 months

Body Composition: Bone area [cm²] using DEXA

Bone area in cm² will be assessed using DEXA

Time frame: 0-3 years

Body Composition: Bone Mineral Content [g] using DEXA

Bone Mineral Content in g will be assessed using DEXA

Time frame: 0-3 years

Body Composition: Bone Mineral Density [g/cm²] using DEXA

Bone Mineral Density in g/cm² will be assessed using DEXA

Time frame: 0-3 years

Body Composition: Fat Free Mass [g] using DEXA

Fat Free Mass in g will be assessed using DEXA

Time frame: 0-3 years

Body Composition: Fat mass [g] using DEXA

Fat mass in g will be assessed using DEXA

Time frame: 0-3 years

Body Composition: Lean mass [g] using DEXA

Lean mass in g will be assessed using DEXA

Time frame: 0-3 years

Body Composition: Percentage fat using DEXA

Percentage fat will be assessed using DEXA

Time frame: 0-3 years

Body Composition: Total mass [g] using DEXA

Total mass in g will be assessed using DEXA

Time frame: 0-3 years

Stool microbiota profile, and metabolomics endpoints in each group. Associations between microbiota and metabolomics profiles (serum, urine, and stool).

Stool microbiota profile (including proportion of fecal bifidobacteria and other bacterial species that may influence energy homeostasis), and metabolomics profile (metabolite sets related to energy recovery and protein and lipid metabolism assessed in blood, urine, and stool samples) in a subset.

Time frame: 0-4 years