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

NCT ID: NCT02776592

Last Updated: 2017-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-20

Study Completion Date

2016-12-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Child Nutrition Sciences

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

A cow's milk-based formula with added nutrients

Group Type EXPERIMENTAL

Cow's milk-based formula with added nutrients

Intervention Type OTHER

Control

A cow's milk-based formula

Group Type ACTIVE_COMPARATOR

Cow's milk-based formula

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cow's milk-based formula with added nutrients

Intervention Type OTHER

Cow's milk-based formula

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federal University of Bahia

OTHER

Sponsor Role collaborator

Mead Johnson Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jon Vanderhoof, M.D.

Role: STUDY_DIRECTOR

Mead Johnson Nutrition

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Center Fima Lifshitz - Federal University of Bahia

Salvador, Estado de Bahia, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

6036

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.