HealthyNCT03111927
Infant Nutrition and Brain Development
A study testing Infant Formula: enriched level of myelin-relevant nutrients and Infant formula: standard level of myelin-relevant nutrients in people with Healthy and Infant Development, run by Société des Produits Nestlé (SPN) at 2 sites in United States.
Trial summary
Research study on the role of early life nutrition on brain and cognitive development during infancy and early childhood. Two blends of myelin-relevant nutrients at different levels were compared and a breastfed group was considered as epidemiological reference. Read more about this study
- Who is it for?
- Ages 2 to 6 weeksHealthy volunteers can take part
- Conditions the study is for
- Healthy, Infant Development
- What is being tested?
- Infant Formula: enriched level of myelin-relevant nutrients and Infant formula: standard level of myelin-relevant nutrients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Mar 2017to 28 Feb 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 2 to 6 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Term infants (≥ 37 weeks)
- Neuro typical development
- No major risk factors for learning, neurologic, or psychiatric disorder
- Between 2 weeks and maximum 5 weeks of age. If mother is breastfeeding she can choose the infant begin the trial prior 2 weeks.
- Parents/legal guardians willing and able to complete the informed consent process
Who cannot join
- Delayed birth (> 41 weeks gestation)
- Birth Weight < 2000 g or small for gestation age or large for gestational age
- Psychopharmacological treatment of mother using prohibited medications during pregnancy
- In utero exposure to alcohol abuse or illicit substances as per the American College of Obstetricians and Gynecologists
- Abnormalities on fetal ultrasound
- Complicated pregnancy
- Neonatal intensive care unit admission and/or emergency surgical delivery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: The Effect of Myelin-Relevant Nutrients in Infant Formula on Brain Myelination and Cognitive Development
Research study on the role of early life nutrition on brain and cognitive development during infancy and early childhood. Two blends of myelin-relevant nutrients at different levels were compared and a breastfed group was considered as epidemiological reference.
Read the detailed description
This nutritional intervention study involved assessments in both the mother and her infant. The mother was asked to complete self-report questionnaires and to undergo a brief cognitive assessment. If the mother was not breastfeeding, a study product was provided and was consumed by the infant daily up to 12 months of life. The study also involved magnetic resonance imaging (MRI) brain scans of the infant's brain while asleep as well as evaluation of cognitive outcomes, including general cognitive development, and social-emotional development.
Once all trial subjects completed the 6-month timepoint (intervention part), an inferential statistical analysis of all data up to 6 months was performed.
Product codes (blinding) were broken to compare groups and an appropriate operational framework was put in place to maintain the individual assignment unknown to the Sponsor and Sites until the end of the trial.
- Conditions
- Healthy, Infant Development
- Being tested
- Infant Formula: enriched level of myelin-relevant nutrients, Infant formula: standard level of myelin-relevant nutrients
- Keywords
- Nutrition, Brain Development, Cognition, Heathy Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Formula: enriched level of myelin-relevant nutrientsOther
Also called Infant Formula
Feeding with the assigned infant formula begun as soon as the child was enrolled in the study (from 2 weeks up to 5 weeks of life) and lasted up to 12 months of age (+/- 2 weeks).
The volume of feed required by the child per day depended upon age, weight, and appetite. The product was given daily ad libitum to the child from enrollment up to 12 months.
Infant formula: standard level of myelin-relevant nutrientsOther
Also called Infant Formula
Feeding with the assigned infant formula begun as soon as the child was enrolled in the study (from 2 weeks up to 5 weeks of life) and lasted up to 12 months of age (+/- 2 weeks).
The volume of feed required by the child per day depended upon age, weight, and appetite. The product was given daily ad libitum to the child from enrollment up to 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Reference Arm: Breastfed | No intervention | Epidemiological reference group of breastfed infants. |
| Investigational | Experimental | Infant Formula: enriched level of myelin-relevant nutrients Receives: Other: Infant Formula: enriched level of myelin-relevant nutrients |
| Control | Active comparator | Infant formula: standard level of myelin-relevant nutrients Receives: Other: Infant formula: standard level of myelin-relevant nutrients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain structural connectivity
Longitudinal analysis de novo myelination and comparison between the 3 study arms De novo myelination being assessed by brain magnetic resonance imaging (MRI; multicomponent relaxometry). [Physiological marker, MRI].
Measured: 3, 6, 12, 18, and 24 months of life
Brain functional connectivity
Cross-sectional analysis de novo myelination and comparison between the 3 study arms De novo myelination being assessed by brain magnetic resonance imaging (MRI; multicomponent relaxometry). [Physiological marker, MRI].
Measured: 3, 6, 12, 18, and 24 months of life
Brain De novo myelination
Brain magnetic resonance imaging (MRI) derived measures (volumetric anatomical imaging) [Physiological marker, MRI].
Measured: 3, 6, 12, 18, and 24 months of life
Infant Cognitive Development
Standardized neurodevelopment test.
Measured: 6, 12, and 24 months of life
Infant Early Learning Assessment
Computer-based cognitive tasks.
Measured: 18 and 24 months of life
Infant Social Emotional Development
Parent report questionnaire.
Measured: 3, 6, 12, 18, and 24 months of life
Secondary outcomes (5)
Infant dietary assessment
Three days food records are planned at the specified time-frames.
Measured: 6, 9, 12, 18, and 24 months of life
Breast milk nutrients profile
Nutrients (vitamins, minerals, and other nutrients) levels analyses in breast milk nutrients (subsample) [Physiological parameter].
Measured: week 3, week 6, and 3 months of life
Brain structure
MRI
Measured: 3, 6, 12, 18, and 24 months of life
Blood nutrients profile (optional)
Nutrients (vitamins, minerals, and other nutrients) levels
Measured: 6, 12, and 24 months of life
Sleep
Questionnaire
Measured: 3, 6, 12, 18, and 24 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start13 Mar 2017
- Primary completion28 Feb 2021
- Study completion28 Feb 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 HealthyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, double blind, randomized, controlled, parallel group clinical trial, consisting of 2 arms randomized to receive either the investigational or the control product, and a nonrandomized, nonblinded arm of fully breastfed infants. 3 groups: enriched level of myelin-relevant nutrients in an Infant Formula, standard level of myelin-relevant nutrients in an Infant Formula, breastfed infants
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Deoni, PhD, Principal investigator, Rhode Island HospitalViren D'Sa, MD, Study director, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111927
- Sponsor's protocol ID
- 16.14.NRC
- Status last verified
- Jul 2022
- First submitted
- 28 Feb 2017
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: MRI scans will be shared between sites. No Personal Identifiable Information will be shared.
Publications
Schneider N, Bruchhage MMK, O'Neill BV, Hartweg M, Tanguy J, Steiner P, Mutungi G, O'Regan J, Mcsweeney S, D'Sa V, Deoni SCL. A Nutrient Formulation Affects Developmental Myelination in Term Infants: A Randomized Clinical Trial. Front Nutr. 2022 Feb 10;9:823893. doi: 10.3389/fnut.2022.823893. eCollection 2022.
PubMed 35242798
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Myelin-Relevant Nutrients in Infant Formula on Brain Myelination and Cognitive Development
- ClinicalTrials.gov ID
- NCT03111927
- Acronym / sponsor ID
- 16.14.NRC
- Conditions
- Healthy, Infant Development
- Keywords
- Nutrition, Brain Development, Cognition, Heathy Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 13 Apr 2017 (actual)
- 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.
Research study on the role of early life nutrition on brain and cognitive development during infancy and early childhood. Two blends of myelin-relevant nutrients at different levels were compared and a breastfed group was considered as epidemiological reference.
Detailed description
This nutritional intervention study involved assessments in both the mother and her infant. The mother was asked to complete self-report questionnaires and to undergo a brief cognitive assessment. If the mother was not breastfeeding, a study product was provided and was consumed by the infant daily up to 12 months of life. The study also involved magnetic resonance imaging (MRI) brain scans of the infant's brain while asleep as well as evaluation of cognitive outcomes, including general cognitive development, and social-emotional development.
Once all trial subjects completed the 6-month timepoint (intervention part), an inferential statistical analysis of all data up to 6 months was performed.
Product codes (blinding) were broken to compare groups and an appropriate operational framework was put in place to maintain the individual assignment unknown to the Sponsor and Sites until the end of the trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Multicenter, double blind, randomized, controlled, parallel group clinical trial, consisting of 2 arms randomized to receive either the investigational or the control product, and a nonrandomized, nonblinded arm of fully breastfed infants. 3 groups: enriched level of myelin-relevant nutrients in an Infant Formula, standard level of myelin-relevant nutrients in an Infant Formula, breastfed infants
| Arm | Type | Receives |
|---|---|---|
| Reference Arm: Breastfed | No intervention | –Epidemiological reference group of breastfed infants. |
| Investigational | Experimental | Other: Infant Formula: enriched level of myelin-relevant nutrientsInfant Formula: enriched level of myelin-relevant nutrients |
| Control | Active comparator | Other: Infant formula: standard level of myelin-relevant nutrientsInfant formula: standard level of myelin-relevant nutrients |
Who may qualify
- Ages
- 2 to 6 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Term infants (≥ 37 weeks)
- Neuro typical development
- No major risk factors for learning, neurologic, or psychiatric disorder
- Between 2 weeks and maximum 5 weeks of age. If mother is breastfeeding she can choose the infant begin the trial prior 2 weeks.
- Parents/legal guardians willing and able to complete the informed consent process
Key exclusion criteria (7 listed)
- Delayed birth (> 41 weeks gestation)
- Birth Weight < 2000 g or small for gestation age or large for gestational age
- Psychopharmacological treatment of mother using prohibited medications during pregnancy
- In utero exposure to alcohol abuse or illicit substances as per the American College of Obstetricians and Gynecologists
- Abnormalities on fetal ultrasound
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 |
|---|---|---|
| Infant Formula: enriched level of myelin-relevant nutrientsAlso: Infant FormulaFeeding with the assigned infant formula begun as soon as the child was enrolled in the study (from 2 weeks up to 5 weeks of life) and lasted up to 12 months of age (+/- 2 weeks). The volume of feed required by the child per day depended upon age, weight, and appetite. The product was given daily ad libitum to the child from enrollment up to 12 months. | Other | Investigational |
| Infant formula: standard level of myelin-relevant nutrientsAlso: Infant FormulaFeeding with the assigned infant formula begun as soon as the child was enrolled in the study (from 2 weeks up to 5 weeks of life) and lasted up to 12 months of age (+/- 2 weeks). The volume of feed required by the child per day depended upon age, weight, and appetite. The product was given daily ad libitum to the child from enrollment up to 12 months. | Other | Control |
Primary outcome
Brain structural connectivity
Time frame: 3, 6, 12, 18, and 24 months of life
Longitudinal analysis de novo myelination and comparison between the 3 study arms De novo myelination being assessed by brain magnetic resonance imaging (MRI; multicomponent relaxometry). [Physiological marker, MRI].
Brain functional connectivity
Time frame: 3, 6, 12, 18, and 24 months of life
Cross-sectional analysis de novo myelination and comparison between the 3 study arms De novo myelination being assessed by brain magnetic resonance imaging (MRI; multicomponent relaxometry). [Physiological marker, MRI].
Brain De novo myelination
Time frame: 3, 6, 12, 18, and 24 months of life
Brain magnetic resonance imaging (MRI) derived measures (volumetric anatomical imaging) [Physiological marker, MRI].
Infant Cognitive Development
Time frame: 6, 12, and 24 months of life
Standardized neurodevelopment test.
Infant Early Learning Assessment
Time frame: 18 and 24 months of life
Computer-based cognitive tasks.
Infant Social Emotional Development
Time frame: 3, 6, 12, 18, and 24 months of life
Parent report questionnaire.
5 secondary outcomes
Infant dietary assessment
Time frame: 6, 9, 12, 18, and 24 months of life
Breast milk nutrients profile
Time frame: week 3, week 6, and 3 months of life
Brain structure
Time frame: 3, 6, 12, 18, and 24 months of life
Blood nutrients profile (optional)
Time frame: 6, 12, and 24 months of life
Sleep
Time frame: 3, 6, 12, 18, and 24 months of life
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 21 Jul 2022.
- Derived from this study: PubMed 35242798Schneider N, Bruchhage MMK, O'Neill BV, Hartweg M, Tanguy J, Steiner P, Mutungi G, O'Regan J, Mcsweeney S, D'Sa V, Deoni SCL. A Nutrient Formulation Affects Developmental Myelination in Term Infants: A Randomized Clinical Trial. Front Nutr. 2022 Feb 10;9:823893. doi: 10.3389/fnut.2022.823893. eCollection 2022.
- Individual participant dataSharing planned: No. MRI scans will be shared between sites. No Personal Identifiable Information will be shared.
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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.
Sean Deoni, PhD principal investigator
Rhode Island Hospital
Viren D'Sa, MD study director
Rhode Island Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Formula: enriched level of myelin-relevant nutrients and Infant formula: standard level of myelin-relevant nutrients in people with Healthy and Infant Development, run by Société des Produits Nestlé (SPN) at 2 sites in United States.
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 5 inclusion and 7 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 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Brain structural connectivity (time frame: 3, 6, 12, 18, and 24 months of life). The study lists 6 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 NCT03111927, 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 21 Jul 2022.