Healthy Term InfantsNCT02646969
Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life
A study testing Formula regimen 1 and Formula regimen 2 in people with Healthy Term Infants, run by Société des Produits Nestlé (SPN) at 9 sites in France.
Trial summary
Growth and metabolic biomarkers of healthy term infants fed formulas with staged protein concentrations over the first year of life Read more about this study
- Who is it for?
- Ages 0 to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Term Infants
- What is being tested?
- Formula regimen 1 and Formula regimen 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 691 participants
- Where
- 9 sitesFrance
- Study dates
- Oct 2015to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU Pellegrin
Bordeaux, Bordeaux, 33000
Hospices Civils de LYON - Hôpital Femme Mère Enfant de Bron
Bron, 69500
Centre Hospitalier Régional Universitaire de Lille
Lille, 59037
Hospices Civils de LYON - Hopital de La Croix Rousse
Lyon, 69229
Assistance Publique-Hôpitaux de Marseille, Hôpital de la Conception
Marseille, 13000
Assistance Publique-Hôpitaux de Marseille, Hôpital NORD
Marseille, 13000
Centre Hospitalier du Belvédère
Mont-Saint-Aignan, 76130
CHU de Nancy - Hôpital Brabois
Nancy, 54511
CHU - Hôpitaux de ROUEN
Rouen, 76031
About this study
Growth and metabolic biomarkers of healthy term infants fed formulas with staged protein concentrations over the first year of life
Read the 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.
- Conditions
- Healthy Term Infants
- Being tested
- Formula regimen 1, Formula regimen 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula regimen 1Dietary supplement
Formula regimen 2Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
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.
Measured: 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
Measured: 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
Measured: 0-4 years
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.
Measured: 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)
Measured: 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)
Measured: 0-4 years
Body Composition: Body density [kg/L] using PeaPod
Body density in kg/L will be assessed using PeaPod
Measured: 1-6 months
Body Composition: Body mass [kg] using PeaPod
Body mass in kg will be assessed using PeaPod
Measured: 1-6 months
Body Composition: Body surface area [cm²] using PeaPod
Body surface area in cm² will be assessed using PeaPod
Measured: 1-6 months
Body Composition: Body volume [L] using PeaPod
Body volume in L will be assessed using PeaPod
Measured: 1-6 months
Body Composition: Fat free mass [kg] using PeaPod
Fat free mass in kg will be assessed using PeaPod
Measured: 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
Measured: 1-6 months
Body Composition: Fat mass [kg] using PeaPod
Fat mass in kg will be assessed using PeaPod
Measured: 1-6 months
Body Composition: Percentage fat free mass using PeaPod
Percentage fat free mass will be assessed using PeaPod
Measured: 1-6 months
Body Composition: Percentage fat mass using PeaPod
Percentage fat mass will be assessed using PeaPod
Measured: 1-6 months
Body Composition: Thoracic gas volume (L) using PeaPod
Thoracic gas volume in L will be assessed using PeaPod
Measured: 1-6 months
Body Composition: Bone area [cm²] using DEXA
Bone area in cm² will be assessed using DEXA
Measured: 0-3 years
Body Composition: Bone Mineral Content [g] using DEXA
Bone Mineral Content in g will be assessed using DEXA
Measured: 0-3 years
Body Composition: Bone Mineral Density [g/cm²] using DEXA
Bone Mineral Density in g/cm² will be assessed using DEXA
Measured: 0-3 years
Body Composition: Fat Free Mass [g] using DEXA
Fat Free Mass in g will be assessed using DEXA
Measured: 0-3 years
Body Composition: Fat mass [g] using DEXA
Fat mass in g will be assessed using DEXA
Measured: 0-3 years
Body Composition: Lean mass [g] using DEXA
Lean mass in g will be assessed using DEXA
Measured: 0-3 years
Body Composition: Percentage fat using DEXA
Percentage fat will be assessed using DEXA
Measured: 0-3 years
Body Composition: Total mass [g] using DEXA
Total mass in g will be assessed using DEXA
Measured: 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.
Measured: 0-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionJul 2022
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Term InfantsStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 691 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sebastien Paoli, MSc, Study chair, Nestlé Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646969
- Sponsor's protocol ID
- 13.13.INF
- Status last verified
- Jan 2023
- First submitted
- 6 Nov 2015
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37929831
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life
- ClinicalTrials.gov ID
- NCT02646969
- Acronym / sponsor ID
- 13.13.INF
- Conditions
- Healthy Term Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 691 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2015 (actual)
- Primary completion
- Jul 2022 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Formula regimen 1 | Active comparator | Dietary Supplement: Formula regimen 1Product 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 |
| Formula regimen 2 | Active comparator | Dietary Supplement: Formula regimen 2Product 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 |
| 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 |
Who may qualify
- Ages
- 0 to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formula regimen 1 | Dietary supplement | Formula regimen 1 |
| Formula regimen 2 | Dietary supplement | Formula regimen 2 |
Primary outcome
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.
25 secondary outcomes
Growth velocity of formula regimen 1 and 2 versus WHO growth curve and versus a human milk (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
Time frame: 6 and 12 months
Compare metabolic biomarkers measures in each formula-fed group to the HM-fed group
Time frame: 0-4 years
Assess the adverse events (AEs) among all study subjects
Time frame: 0-4 years
Assess and compare the child behavior in each group until 4 years of age
Time frame: 0-4 years
Assess and compare the neurodevelopment in each group until 4 years of age
Time frame: 0-4 years
Body Composition: Body density [kg/L] using PeaPod
Time frame: 1-6 months
Body Composition: Body mass [kg] using PeaPod
Time frame: 1-6 months
Body Composition: Body surface area [cm²] using PeaPod
Time frame: 1-6 months
Body Composition: Body volume [L] using PeaPod
Time frame: 1-6 months
Body Composition: Fat free mass [kg] using PeaPod
Time frame: 1-6 months
Body Composition: Fat free mass density [kg/L] using PeaPod
Time frame: 1-6 months
Body Composition: Fat mass [kg] using PeaPod
Time frame: 1-6 months
Body Composition: Percentage fat free mass using PeaPod
Time frame: 1-6 months
Body Composition: Percentage fat mass using PeaPod
Time frame: 1-6 months
Body Composition: Thoracic gas volume (L) using PeaPod
Time frame: 1-6 months
Body Composition: Bone area [cm²] using DEXA
Time frame: 0-3 years
Body Composition: Bone Mineral Content [g] using DEXA
Time frame: 0-3 years
Body Composition: Bone Mineral Density [g/cm²] using DEXA
Time frame: 0-3 years
Body Composition: Fat Free Mass [g] using DEXA
Time frame: 0-3 years
Body Composition: Fat mass [g] using DEXA
Time frame: 0-3 years
Body Composition: Lean mass [g] using DEXA
Time frame: 0-3 years
Body Composition: Percentage fat using DEXA
Time frame: 0-3 years
Body Composition: Total mass [g] 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).
Time frame: 0-4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Derived from this study: PubMed 37929831Gonzalez-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.
Related trials for Healthy Term Infants
Active, not recruiting
Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
Recruiting
Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula
Healthy Term Infants
Not yet recruitingPhase 3
A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants
Infant ALL
Active, not recruiting
Goat Infant Formula Feeding and Eczema (the GIraFFE Study)
Dermatitis, Atopic, Eczema, Infantile
Recruiting
Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
Infant Nutritional Physiological Phenomena, Infant Formula
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastien Paoli, MSc study chair
Nestlé Research
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formula regimen 1 and Formula regimen 2 in people with Healthy Term Infants, run by Société des Produits Nestlé (SPN) at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth velocity of formula regimen 1 and 2 versus WHO growth curve (time frame: 0-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02646969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.