Effect of the Level of Dietary Protein on Infant Growth

N

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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