Effect of the Level of Dietary Protein on Infant Growth

• Sponsor: Nestlé (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00716105
• Collaborator: (none)
• Enrollment: 405
• Locations: 2
• Arms: 3
• Duration (Months): 78
• Patients Per Site: 202.5
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infant Nutrition	Other: Standard infant formula; Other: Infant formula with different level of proteins	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 405 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Official Title: Effect of the Level of Dietary Protein on Infant Growth and Body Composition in the First Year of Life
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mean weight gain [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 12 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa	Iowa City	Iowa	United States	52242
2	Department of Pediatrics University of Oklahoma Health Sciences	Oklahoma City	Oklahoma	United States	73102

Sponsors and Collaborators

• Nestlé

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT00716105
• Other Study ID Numbers: 06.29.INF
• First Posted: Jul 16, 2008
• Last Update Posted: May 19, 2015
• Last Verified: Oct 1, 2014

• Keywords provided by Nestlé: Infant formula; Protein metabolism

Study Results

No Results Posted as of May 19, 2015