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NCT01489098 Clinical Trial

Effect of the Level of Dietary Protein on Body Composition

Growth Acceleration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01489098
Other study ID # 06.29.INF Addendum
Secondary ID
Status Completed
Phase N/A
First received December 2, 2011
Last updated March 17, 2015
Start date September 2011
Est. completion date February 2015

Study information
Verified date October 2014
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 178
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 6 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States The Samuel J Fomon Infant Nutrition Unit Department of Pediatrics, University of Iowa Iowa City Iowa
United States Department of Pediatrics, University of Oklahoma Health Sciences Oklahoma City Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean weight gain 3 years No
Primary Mean weight gain 5 years No
Secondary Body composition 3 years No
Secondary Body composition 5 years No
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