Nutritive Effects of a Cow's Milk Based Formula Fed to Young Children

Child Nutrition Sciences Clinical Trial

Official title:

Nutritive Effects of a Cow's Milk Based Formula Fed to Young Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776592
• Other study ID #: 6036
• Status: Completed
• Phase: N/A
• First received: May 12, 2016
• Last updated: March 14, 2017
• Start date: July 20, 2016
• Est. completion date: December 23, 2016

Study information

• Verified date: March 2017
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: December 23, 2016
• Est. primary completion date: December 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Nutrition Sciences

Intervention

Other:
• Cow's milk-based formula with added nutrients

• Cow's milk-based formula

Locations

Country	Name	City	State
Brazil	Research Center Fima Lifshitz - Federal University of Bahia	Salvador	Bahia

Sponsors (2)

Lead Sponsor	Collaborator
Mead Johnson Nutrition	Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Working Memory Capacity	Recall of variable sequences	Up to 24 weeks
Secondary	Change in Motor Response Speeds		Up to 24 weeks
Secondary	Change in Mental Response Speeds		Up to 24 weeks
Secondary	Change in Retention of Visual Information		Up to 24 weeks
Secondary	Change in Manipulation of Visual Information		Up to 24 weeks
Secondary	Change in Child Behavior Checklist	Assessment of adaptive function	Up to 24 weeks
Secondary	Stool Consistency Assessment		24 weeks
Secondary	Systemic antibiotic Usage		24 weeks
Secondary	Missed days due to illness		24 weeks
Secondary	Body Weight		24 weeks
Secondary	Height		24 weeks
Secondary	Study Product Intake Assessment		24 weeks
Secondary	Complete Blood Count (CBC)		Up to 24 weeks
Secondary	Blood Fatty Acids		Up to 24 weeks
Secondary	Metabolite Biomarkers		Up to 24 weeks
Secondary	Serum Phospholipids		Up to 24 weeks
Secondary	Immune Markers		Up to 24 weeks
Secondary	Medically-confirmed adverse events		24 weeks