Effect of the Level of Dietary Protein on Infant Growth

Infant Nutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716105
• Other study ID #: 06.29.INF
• Status: Completed
• Phase: N/A
• First received: July 11, 2008
• Last updated: May 18, 2015
• Start date: August 2008
• 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: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: February 2015
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 12 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Infant Nutrition

Intervention

Other:
• Standard infant formula
From 3 to 12 months of age. As per standard requirement
• Infant formula with different level of proteins
From 3 to 12 months of age. As per standard requirement

Locations

Country	Name	City	State
United States	The Samuel J. Fomon Infant Nutrition Unit Dept 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		6 months	Yes