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Completed

NCT Number: NCT02776592

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

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.

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Key information

Age range

4 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Center Fima Lifshitz - Federal University of Bahia

Salvador, Estado de Bahia, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cow's milk-based formula with added nutrients

Other

Cow's milk-based formula

Other

Primary outcomes

  1. Change in Working Memory Capacity

    Time frame: Up to 24 weeks

    Recall of variable sequences

Secondary outcomes

  1. Change in Motor Response Speeds

    Time frame: Up to 24 weeks

  2. Change in Mental Response Speeds

    Time frame: Up to 24 weeks

  3. Change in Retention of Visual Information

    Time frame: Up to 24 weeks

  4. Change in Manipulation of Visual Information

    Time frame: Up to 24 weeks

  5. Change in Child Behavior Checklist

    Time frame: Up to 24 weeks

    Assessment of adaptive function

  6. Stool Consistency Assessment

    Time frame: 24 weeks

  7. Systemic antibiotic Usage

    Time frame: 24 weeks

  8. Missed days due to illness

    Time frame: 24 weeks

  9. Body Weight

    Time frame: 24 weeks

  10. Height

    Time frame: 24 weeks

  11. Study Product Intake Assessment

    Time frame: 24 weeks

  12. Complete Blood Count (CBC)

    Time frame: Up to 24 weeks

  13. Blood Fatty Acids

    Time frame: Up to 24 weeks

  14. Metabolite Biomarkers

    Time frame: Up to 24 weeks

  15. Serum Phospholipids

    Time frame: Up to 24 weeks

  16. Immune Markers

    Time frame: Up to 24 weeks

  17. Medically-confirmed adverse events

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Collaborators

  • Federal University of Bahia

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 18, 2016
Registry last updated
Mar 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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