Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of the Level of Dietary Protein on Body Composition

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Nestlé Identifier:
First received: December 2, 2011
Last updated: October 31, 2014
Last verified: October 2014

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.

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:

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: December 2014 (Final data collection date for primary outcome measure)
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


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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01489098

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
  More Information

No publications provided

Responsible Party: Nestlé Identifier: NCT01489098     History of Changes
Other Study ID Numbers: 06.29.INF Addendum
Study First Received: December 2, 2011
Last Updated: October 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Nestlé:
Body composition
Protein Metabolism processed this record on March 03, 2015