Clincosm LogoSign in Get a demo

Effect of the Level of Dietary Protein on Body Composition

Sponsor
Nestlé (Industry)
Overall Status
Completed
CT.gov ID
NCT01489098
Collaborator
(none)
178
Enrollment
2
Locations
41
Duration (Months)
89
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    178 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    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
    Study Start Date :
    Sep 1, 2011
    Actual Primary Completion Date :
    Feb 1, 2015
    Actual Study Completion Date :
    Feb 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Mean weight gain [3 years]

    2. Mean weight gain [5 years]

    Secondary Outcome Measures

    1. Body composition [3 years]

    2. Body composition [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Samuel J Fomon Infant Nutrition Unit Department of Pediatrics, University of Iowa Iowa City Iowa United States 552242
    2 Department of Pediatrics, University of Oklahoma Health Sciences Oklahoma City Oklahoma United States 73102

    Sponsors and Collaborators

    • Nestlé

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nestlé
    ClinicalTrials.gov Identifier:
    NCT01489098
    Other Study ID Numbers:
    • 06.29.INF Addendum
    First Posted:
    Dec 9, 2011
    Last Update Posted:
    Mar 18, 2015
    Last Verified:
    Oct 1, 2014
    Keywords provided by Nestlé
    Body composition
    Protein Metabolism

    Study Results

    No Results Posted as of Mar 18, 2015