NCT02776592CompletedNot Applicable
Nutritive Effects of a Cow's Milk Based Formula Fed to Young Children
Mead Johnson Nutrition1 site in 1 country199 target enrollmentStarted: July 20, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 199
- Locations
- 1
- Primary Endpoint
- Change in Working Memory Capacity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 4 Years to 5 Years (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Change in Working Memory Capacity
Time Frame: Up to 24 weeks
Recall of variable sequences
Secondary Outcomes
- Change in Motor Response Speeds(Up to 24 weeks)
- Stool Consistency Assessment(24 weeks)
- Height(24 weeks)
- Metabolite Biomarkers(Up to 24 weeks)
- Blood Fatty Acids(Up to 24 weeks)
- Change in Mental Response Speeds(Up to 24 weeks)
- Change in Manipulation of Visual Information(Up to 24 weeks)
- Change in Retention of Visual Information(Up to 24 weeks)
- Change in Child Behavior Checklist(Up to 24 weeks)
- Immune Markers(Up to 24 weeks)
- Systemic antibiotic Usage(24 weeks)
- Missed days due to illness(24 weeks)
- Body Weight(24 weeks)
- Study Product Intake Assessment(24 weeks)
- Complete Blood Count (CBC)(Up to 24 weeks)
- Serum Phospholipids(Up to 24 weeks)
- Medically-confirmed adverse events(24 weeks)
Investigators
Study Sites (1)
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