Effect of the Level of Dietary Protein on Infant Growth

The purpose of this study is to determine whether infants fed a formula with protein levels different than a standard infant formula have similar growth and development.

Completed

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Key information

Conditions

Infant Nutrition

Age range

3 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Gestational age at least 37 weeks
Singleton birth
Birth weight between 2500g and 4500g
Weight at enrolment is at or above the 5th percentile (CDC)
Infant has been exclusively formula fed for at least the last 14 days
Having obtained informed consent of legal representative

Exclusion criteria

Congenital illness or malformation that affects infant feeding and/or growth
Significant pre-natal and/or post-natal disease
Suspected or confirmed allergy to cow milk protein
In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen)
Currently participating in another clinical trial

Treatment and study plan

Standard Infant Formula

Other

From 3 to 12 months of age. As per standard requirement

Infant formula with different level of proteins

Other

From 3 to 12 months of age. As per standard requirement

Primary outcomes

Mean weight gain

Time frame: 6 months

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2015
First posted: Jul 16, 2008
Registry last updated: May 19, 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