Clinical trial NCT02646969: Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life
Official title: Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Term Infants
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2016-01-06
Enrollment: 691
Sex: ALL
Minimum age (years): 0
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Growth velocity of formula regimen 1 and 2 versus WHO growth curve
timeFrame: 0-6 months
measure: Growth velocity (g/day) of formula regimen 1 and 2 versus a human milk (HM)-fed comparator group
timeFrame: 0-6 months
Secondary outcomes:
measure: Growth velocity of formula regimen 1 and 2 versus WHO growth curve and versus a human milk (HM)-fed comparator group
timeFrame: 0-3 months and 0-12 months
measure: Other growth parameters z-scores of formula regimen 1 and 2 versus WHO standards and versus a human milk (HM)-fed comparator group
timeFrame: 6 and 12 months
measure: Compare metabolic biomarkers measures in each formula-fed group to the HM-fed group
timeFrame: 0-4 years
measure: Assess the adverse events (AEs) among all study subjects
timeFrame: 0-4 years
measure: Assess and compare the child behavior in each group until 4 years of age
timeFrame: 0-4 years
measure: Assess and compare the neurodevelopment in each group until 4 years of age
timeFrame: 0-4 years
measure: Body Composition: Body density [kg/L] using PeaPod
timeFrame: 1-6 months
measure: Body Composition: Body mass [kg] using PeaPod
timeFrame: 1-6 months
measure: Body Composition: Body surface area [cm²] using PeaPod
timeFrame: 1-6 months
measure: Body Composition: Body volume [L] using PeaPod
timeFrame: 1-6 months
measure: Body Composition: Fat free mass [kg] using PeaPod
timeFrame: 1-6 months
measure: Body Composition: Fat free mass density [kg/L] using PeaPod
timeFrame: 1-6 months
measure: Body Composition: Fat mass [kg] using PeaPod
timeFrame: 1-6 months
measure: Body Composition: Percentage fat free mass using PeaPod
timeFrame: 1-6 months
measure: Body Composition: Percentage fat mass using PeaPod
timeFrame: 1-6 months
measure: Body Composition: Thoracic gas volume (L) using PeaPod
timeFrame: 1-6 months
measure: Body Composition: Bone area [cm²] using DEXA
timeFrame: 0-3 years
measure: Body Composition: Bone Mineral Content [g] using DEXA
timeFrame: 0-3 years
measure: Body Composition: Bone Mineral Density [g/cm²] using DEXA
timeFrame: 0-3 years
measure: Body Composition: Fat Free Mass [g] using DEXA
timeFrame: 0-3 years
measure: Body Composition: Fat mass [g] using DEXA
timeFrame: 0-3 years
measure: Body Composition: Lean mass [g] using DEXA
timeFrame: 0-3 years
measure: Body Composition: Percentage fat using DEXA
timeFrame: 0-3 years
measure: Body Composition: Total mass [g] using DEXA
timeFrame: 0-3 years
measure: Stool microbiota profile, and metabolomics endpoints in each group. Associations between microbiota and metabolomics profiles (serum, urine, and stool).
timeFrame: 0-4 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Pellegrin
city: Bron
country: France
facility: Hospices Civils de LYON - Hôpital Femme Mère Enfant de Bron
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
city: Lyon
country: France
facility: Hospices Civils de LYON - Hopital de La Croix Rousse
city: Marseille
country: France
facility: Assistance Publique-Hôpitaux de Marseille, Hôpital de la Conception
city: Marseille
country: France
facility: Assistance Publique-Hôpitaux de Marseille, Hôpital NORD
city: Mont-Saint-Aignan
country: France
facility: Centre Hospitalier du Belvédère
city: Nancy
country: France
facility: CHU de Nancy - Hôpital Brabois
city: Rouen
country: France
facility: CHU - Hôpitaux de ROUEN
Study officials:
affiliation: Nestlé Research
name: Sebastien Paoli, MSc
role: STUDY_CHAIR
References: