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

NCT02646969 | Completed DMC

• 1 other identifier: 13.13.INF
• Study Type: interventional
• Target: 691
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Healthy Term Infants

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (25)

• 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

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

  0-4 years

• Assess the adverse events (AEs) among all study subjects

  0-4 years

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

  0-4 years

Study Arms (3)

Formula regimen 1

ACTIVE COMPARATOR

Product Control from enrollment to transition phase 1 (blinded administration), followed by open label administration for 2 months. Product Test 2 from transition phase 2 to 1 year old (open label) Commercial follow up formula from 1 year old

Dietary Supplement: Formula regimen 1

Formula regimen 2

ACTIVE COMPARATOR

Product Test 1 from enrollment to transition phase 1 (blinded administration) Product Control for 2 months(open label) Product Test 2 from transition phase 2 to 1 year old (open label) Commercial follow up formula from 1 year old

Dietary Supplement: Formula regimen 2

Reference group

NO INTERVENTION

Infants fed HM exclusively through at least 4 months of age. Once breastfeeding is over and if wished Infant will receive Product test 2 until 1 year old followed by the commercial follow-up formula

Interventions

Formula regimen 1 DIETARY_SUPPLEMENT

Formula regimen 1

Formula regimen 2 DIETARY_SUPPLEMENT

Formula regimen 2

Eligibility Criteria

• Age: 0 Days - 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (9)

CHU Pellegrin

Bordeaux, Bordeaux, 33000, France

Location

Hospices Civils de LYON - Hôpital Femme Mère Enfant de Bron

Bron, 69500, France

Location

Centre Hospitalier Régional Universitaire de Lille

Lille, 59037, France

Location

Hospices Civils de LYON - Hopital de La Croix Rousse

Lyon, 69229, France

Location

Assistance Publique-Hôpitaux de Marseille, Hôpital de la Conception

Marseille, 13000, France

Location

Assistance Publique-Hôpitaux de Marseille, Hôpital NORD

Marseille, 13000, France

Location

Centre Hospitalier du Belvédère

Mont-Saint-Aignan, 76130, France

Location

CHU de Nancy - Hôpital Brabois

Nancy, 54511, France

Location

CHU - Hôpitaux de ROUEN

Rouen, 76031, France

Location

Related Publications (1)

• 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.

  PMID: 37929831 DERIVED

Study Officials

• Sebastien Paoli, MSc

  Nestlé Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: January 6, 2016
• Study Start: October 1, 2015
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: May 15, 2025

Record last verified: 2023-01

Locations

FR (9)