Effect of the Level of Dietary Protein on Body Composition

March 17, 2015 updated by: Société des Produits Nestlé (SPN)

Effect of the Level of Dietary Protein on Infant Growth and Body Composition in the First Year of Life - Three and Five Year Growth and Body Composition Follow-up

The purpose of this study is to determine if toddlers and children who were fed breast milk or infant formulas at different levels of protein between 3 and 12 months of age have differences in growth and body composition at 3 and 5 years of age.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 552242
        • The Samuel J Fomon Infant Nutrition Unit Department of Pediatrics, University of Iowa
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Department of Pediatrics, University of Oklahoma Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Toddlers and Children who have previously participated in an infant formula trial where various levels of protein were provided and who are now at the age of 3 and 5 years.

Description

Inclusion Criteria:

  • Previous participation in infant formula controlled protein study
  • Body composition data from 6 month of age available
  • Consent obtained from legal representative
  • Within age parameters specified in protocol around the 3 and 5 year age points

Exclusion Criteria:

  • Unable to endure testing procedures upon evaluation of the Investigator
  • Outside the age range of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breast Fed reference group
3 and 5 year olds from the above group
Infant formula - protein level 1
3 ad 5 year olds from the above group
Infant formula - protein level 2
3 and 5 year olds from the above group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean weight gain
Time Frame: 3 years
3 years
Mean weight gain
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Body composition
Time Frame: 3 years
3 years
Body composition
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

December 2, 2011

First Submitted That Met QC Criteria

December 8, 2011

First Posted (Estimate)

December 9, 2011

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 06.29.INF Addendum

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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