Effect of the Level of Dietary Protein on Body Composition

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Growth Acceleration

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Samuel J Fomon Infant Nutrition Unit Department of Pediatrics, University of Iowa, Iowa City, Iowa, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Mean weight gain

Time frame: 3 years
Mean weight gain

Time frame: 5 years

Secondary outcomes

Body composition

Time frame: 3 years
Body composition

Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Dec 9, 2011
Registry last updated: Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed