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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference Arm: Breastfed | No Intervention | Epidemiological reference group of breastfed infants. | |
| Investigational | Experimental | Infant Formula: enriched level of myelin-relevant nutrients |
|
| Control | Active Comparator | Infant formula: standard level of myelin-relevant nutrients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant Formula: enriched level of myelin-relevant nutrients | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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]. | 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]. | 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]. | 3, 6, 12, 18, and 24 months of life |
| Infant Cognitive Development | Standardized neurodevelopment test. | 6, 12, and 24 months of life |
| Infant Early Learning Assessment | Computer-based cognitive tasks. | 18 and 24 months of life |
| Infant Social Emotional Development | Parent report questionnaire. | 3, 6, 12, 18, and 24 months of life |
| Measure | Description | Time Frame |
|---|---|---|
| Infant dietary assessment | Three days food records are planned at the specified time-frames. | 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]. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean Deoni, PhD | Rhode Island Hospital | Principal Investigator |
| Viren D'Sa, MD | Rhode Island Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States | ||
| Rhode Island Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35242798 | Derived | 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. |
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MRI scans will be shared between sites. No Personal Identifiable Information will be shared.
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| ID | Term |
|---|---|
| D041943 | Infant Formula |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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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
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Double blind - Infant Formula arms are blinded;
|
|
| Infant formula: standard level of myelin-relevant nutrients | Other | 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. |
|
|
| week 3, week 6, and 3 months of life |
| Brain structure | MRI | 3, 6, 12, 18, and 24 months of life |
| Blood nutrients profile (optional) | Nutrients (vitamins, minerals, and other nutrients) levels | 6, 12, and 24 months of life |
| Sleep | Questionnaire | 3, 6, 12, 18, and 24 months of life |
| Providence |
| Rhode Island |
| 02903 |
| United States |
| D005526 |
| Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |