Effect of the Level of Dietary Protein on Infant Growth

May 18, 2015 updated by: Nestlé

Effect of the Level of Dietary Protein on Infant Growth and Body Composition in the First Year of Life

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

405

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Department of Pediatrics University of Oklahoma Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Standard Infant Formula
Other: Standard infant formula
From 3 to 12 months of age. As per standard requirement
Experimental: Test Product
Infant formula with different level of proteins
Other: Infant formula with different level of proteins
From 3 to 12 months of age. As per standard requirement
No Intervention: Breast Milk
Breastfeeding reference group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean weight gain
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Ekhard E Ziegler, MD, The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 11, 2008

First Submitted That Met QC Criteria

July 15, 2008

First Posted (Estimate)

July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 06.29.INF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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