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

Healthy Term Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646969
• Other study ID #: 13.13.INF
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: July 2022

Study information

• Verified date: January 2023
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 691
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Days to 7 Days

Eligibility

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

Related Conditions & MeSH terms

• Healthy Term Infants

Intervention

Dietary Supplement:
• Formula regimen 1

• Formula regimen 2

Locations

Country	Name	City	State
France	CHU Pellegrin	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	Lyon
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0-6 months
Primary	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.	0-6 months
Secondary	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.	0-3 months and 0-12 months
Secondary	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	6 and 12 months
Secondary	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	0-4 years
Secondary	Assess the adverse events (AEs) among all study subjects	Assess the type, incidence, severity, seriousness, and relationship to study formulas of AEs among study subjects.	0-4 years
Secondary	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)	0-4 years
Secondary	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)	0-4 years
Secondary	Body Composition: Body density [kg/L] using PeaPod	Body density in kg/L will be assessed using PeaPod	1-6 months
Secondary	Body Composition: Body mass [kg] using PeaPod	Body mass in kg will be assessed using PeaPod	1-6 months
Secondary	Body Composition: Body surface area [cm²] using PeaPod	Body surface area in cm² will be assessed using PeaPod	1-6 months
Secondary	Body Composition: Body volume [L] using PeaPod	Body volume in L will be assessed using PeaPod	1-6 months
Secondary	Body Composition: Fat free mass [kg] using PeaPod	Fat free mass in kg will be assessed using PeaPod	1-6 months
Secondary	Body Composition: Fat free mass density [kg/L] using PeaPod	Fat free mass density in kg/L will be assessed using PeaPod	1-6 months
Secondary	Body Composition: Fat mass [kg] using PeaPod	Fat mass in kg will be assessed using PeaPod	1-6 months
Secondary	Body Composition: Percentage fat free mass using PeaPod	Percentage fat free mass will be assessed using PeaPod	1-6 months
Secondary	Body Composition: Percentage fat mass using PeaPod	Percentage fat mass will be assessed using PeaPod	1-6 months
Secondary	Body Composition: Thoracic gas volume (L) using PeaPod	Thoracic gas volume in L will be assessed using PeaPod	1-6 months
Secondary	Body Composition: Bone area [cm²] using DEXA	Bone area in cm² will be assessed using DEXA	0-3 years
Secondary	Body Composition: Bone Mineral Content [g] using DEXA	Bone Mineral Content in g will be assessed using DEXA	0-3 years
Secondary	Body Composition: Bone Mineral Density [g/cm²] using DEXA	Bone Mineral Density in g/cm² will be assessed using DEXA	0-3 years
Secondary	Body Composition: Fat Free Mass [g] using DEXA	Fat Free Mass in g will be assessed using DEXA	0-3 years
Secondary	Body Composition: Fat mass [g] using DEXA	Fat mass in g will be assessed using DEXA	0-3 years
Secondary	Body Composition: Lean mass [g] using DEXA	Lean mass in g will be assessed using DEXA	0-3 years
Secondary	Body Composition: Percentage fat using DEXA	Percentage fat will be assessed using DEXA	0-3 years
Secondary	Body Composition: Total mass [g] using DEXA	Total mass in g will be assessed using DEXA	0-3 years
Secondary	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.	0-4 years