Child Nutrition Sciences
Conditions
Keywords
Healthy Children
Brief summary
This study aims to determine if a cow's milk-based formula with added nutrients has an effect on memory, reaction time, strategy or other cognitive development indicators in children 4-5 years of age.
Detailed description
This study aims to determine if a cow's milk-based formula with added nutrients has an effect on memory, reaction time, strategy or other cognitive development indicators in children 4-5 years of age.
Interventions
OTHERCow's milk-based formula with added nutrients
OTHERCow's milk-based formula
Sponsors
Federal University of Bahia
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Health child, 4-5 years of age * Born as full-term (Gestational age of 37-42 weeks) * Consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to the baseline visit * Parents or legal guardian agrees not to feed child any food products or supplements containing probiotics or prebiotics * Signed informed consent
Exclusion criteria
* History or known or suspected cow milk protein intolerance * Child who has received any food product ot supplement containing probiotics or prebiotics (with the exception of yogurt) in the 15 days prior to the baseline visit * Serious concurrent illness that will interfere in the general management of the child * History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised * Child's z-score of weight for height at baseline is \< -3 according to WHO criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Working Memory Capacity | Up to 24 weeks | Recall of variable sequences |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mental Response Speeds | Up to 24 weeks | — |
| Change in Retention of Visual Information | Up to 24 weeks | — |
| Change in Manipulation of Visual Information | Up to 24 weeks | — |
| Change in Child Behavior Checklist | Up to 24 weeks | Assessment of adaptive function |
| Stool Consistency Assessment | 24 weeks | — |
| Systemic antibiotic Usage | 24 weeks | — |
| Missed days due to illness | 24 weeks | — |
| Body Weight | 24 weeks | — |
| Change in Motor Response Speeds | Up to 24 weeks | — |
| Study Product Intake Assessment | 24 weeks | — |
| Complete Blood Count (CBC) | Up to 24 weeks | — |
| Blood Fatty Acids | Up to 24 weeks | — |
| Metabolite Biomarkers | Up to 24 weeks | — |
| Serum Phospholipids | Up to 24 weeks | — |
| Immune Markers | Up to 24 weeks | — |
| Medically-confirmed adverse events | 24 weeks | — |
| Height | 24 weeks | — |
Countries
Brazil
Outcome results
None listed