Effect of Formula on Growth of Infants From Overweight or Obese Mothers

Nestlé

Status: Completed

Conditions: Infant Nutrition

Treatments: Other: Test formula; Other: standard infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT00820833

05.29.INF

Details and patient eligibility

About

The purpose of this study is to determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth

Enrollment: 230 patients

Sex: All

Ages: 3 to 12 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy newborn infant
• birth weight between 2500g and 4800g
• singleton birth
• mother's BMI before pregnancy was between 26 and 25
• for the breastfeeding group: mother has elected to exclusively breastfeed her baby from birth to at least 6 months of age
• for the formula groups: mother has elected to exclusively formula feed her baby from 3 to 6 months of age
• having obtained signed informed consent of legal representative

Exclusion criteria

• body weight smaller than 5th percentile for that gestational age
• newborn whose mother has diabetes
• newborn whose mother has a drug dependence during pregnancy
• newborn currently participating in another trial

Trial design

230 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Standard infant formula

Treatment:

Other: standard infant formula

2

Experimental group

Description:

Test formula

Treatment:

Other: Test formula

3

No Intervention group

Description:

Breastfeeding reference group