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

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Mead Johnson Nutrition

Status

Completed

Conditions

Child Nutrition Sciences

Treatments

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

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02776592
6036 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

199 patients

Sex

All

Ages

4 to 5 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

199 participants in 2 patient groups

Experimental
Experimental group
Description:
A cow's milk-based formula with added nutrients
Treatment:
Other: Cow's milk-based formula with added nutrients
Control
Active Comparator group
Description:
A cow's milk-based formula
Treatment:
Other: Cow's milk-based formula

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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