Effect of the Level of Dietary Protein on Body Composition

Completed

• Conditions: Growth Acceleration

• Registration Number: NCT01489098
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-08
• Study First Posted: 2011-12-09
• Status Verified: 2014-10
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean weight gain	5 years

Secondary Outcome Measures

Name	Time	Method
Body composition	5 years

Trial Locations

Locations (2)

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, United States