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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Child Nutrition Sciences

Intervention / Treatment
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* Other: Cow's milk-based formula with added nutrients
* Other: Cow's milk-based formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>A cow's milk-based formula with added nutrients | Other: Cow's milk-based formula with added nutrients<br> <br> |
| Active Comparator: Control<br>A cow's milk-based formula | Other: Cow's milk-based formula<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Working Memory Capacity | Recall of variable sequences | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Motor Response Speeds |  | Up to 24 weeks | 
| 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 | Assessment of adaptive function | Up to 24 weeks | 
| Stool Consistency Assessment |  | 24 weeks | 
| Systemic antibiotic Usage |  | 24 weeks | 
| Missed days due to illness |  | 24 weeks | 
| Body Weight |  | 24 weeks | 
| Height |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Children