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Effect of the Level of Dietary Protein on Body Composition

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01489098
First received: December 2, 2011
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Growth Acceleration

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Mean weight gain [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Mean weight gain [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489098

Locations
United States, Iowa
The Samuel J Fomon Infant Nutrition Unit Department of Pediatrics, University of Iowa
Iowa City, Iowa, United States, 552242
United States, Oklahoma
Department of Pediatrics, University of Oklahoma Health Sciences
Oklahoma City, Oklahoma, United States, 73102
Sponsors and Collaborators
Nestlé
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01489098     History of Changes
Other Study ID Numbers: 06.29.INF Addendum
Study First Received: December 2, 2011
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Nestlé:
Body composition
Protein Metabolism

ClinicalTrials.gov processed this record on May 16, 2013