Effect of the Level of Dietary Protein on Infant Growth

Nestlé

Status: Completed

Conditions: Infant Nutrition

Treatments: Other: Infant formula with different level of proteins; Other: Standard infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT00716105

06.29.INF

Details and patient eligibility

About

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.

Enrollment: 405 patients

Sex: All

Ages: 3 to 12 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

405 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Standard Infant Formula

Treatment:

Other: Standard infant formula

Test Product

Experimental group

Description:

Infant formula with different level of proteins

Treatment:

Other: Infant formula with different level of proteins

Breast Milk

No Intervention group

Description:

Breastfeeding reference group