Clinical trial NCT02776592: Nutritive Effects of a Cow's Milk Based Formula Fed to Young Children
Official title: Nutritive Effects of a Cow's Milk Based Formula Fed to Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Nutrition Sciences
Keywords: Healthy Children
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Federal University of Bahia
First posted: 2016-05-18
Enrollment: 199
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Working Memory Capacity
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Change in Motor Response Speeds
timeFrame: Up to 24 weeks
measure: Change in Mental Response Speeds
timeFrame: Up to 24 weeks
measure: Change in Retention of Visual Information
timeFrame: Up to 24 weeks
measure: Change in Manipulation of Visual Information
timeFrame: Up to 24 weeks
measure: Change in Child Behavior Checklist
timeFrame: Up to 24 weeks
measure: Stool Consistency Assessment
timeFrame: 24 weeks
measure: Systemic antibiotic Usage
timeFrame: 24 weeks
measure: Missed days due to illness
timeFrame: 24 weeks
measure: Body Weight
timeFrame: 24 weeks
measure: Height
timeFrame: 24 weeks
measure: Study Product Intake Assessment
timeFrame: 24 weeks
measure: Complete Blood Count (CBC)
timeFrame: Up to 24 weeks
measure: Blood Fatty Acids
timeFrame: Up to 24 weeks
measure: Metabolite Biomarkers
timeFrame: Up to 24 weeks
measure: Serum Phospholipids
timeFrame: Up to 24 weeks
measure: Immune Markers
timeFrame: Up to 24 weeks
measure: Medically-confirmed adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Research Center Fima Lifshitz - Federal University of Bahia
state: Bahia
Study officials:
affiliation: Mead Johnson Nutrition
name: Jon Vanderhoof, M.D.
role: STUDY_DIRECTOR
References: