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Effect of the Level of Dietary Protein on Body Composition

This study has been completed.
Information provided by (Responsible Party):
Nestlé Identifier:
First received: December 2, 2011
Last updated: March 17, 2015
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 ]
  • Mean weight gain [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: 3 years ]
  • Body composition [ Time Frame: 5 years ]

Enrollment: 178
Study Start Date: September 2011
Study Completion Date: February 2015
Primary Completion Date: February 2015 (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   (Child)
Sexes Eligible for Study:   All
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

Responsible Party: Nestlé Identifier: NCT01489098     History of Changes
Other Study ID Numbers: 06.29.INF Addendum
Study First Received: December 2, 2011
Last Updated: March 17, 2015

Keywords provided by Nestlé:
Body composition
Protein Metabolism processed this record on August 18, 2017