Effect of the Level of Dietary Protein on the Infant Hormonal Profile and Body Composition

Nestlé

Status

Completed

Conditions

Healthy

Treatments

Other: High protein formula

Other: Low protein formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT02282488

05.14.INF

Details and patient eligibility

About

A double blind, controlled, randomized, single site clinical trial of 2 parallel groups (Low protein formula =LoF and High protein formula =HiF) with a breastfeeding group (BF) as reference from birth to 1 year of age and a follow up period from 1 year to 5 years of age.

Full description

The primary objective of this clinical trial is to show that infants taking (from birth) either a formula with a low protein content (LoF) or breast milk will have an IGF-1 level, at 4 months, 25% lower to the IGF-1 measured in infants that received a high protein content formula (HiF).

The secondary objectives are: The hormonal profile; the Fat mass (FM) gain and the Lean mass (LM); the metabolomics and aminogramm during the first year of life.

Subjects are included in the study for a duration of 5 years. From birth to 4 months they are exclusively fed BF or FF. From 4 months of age they can start diversification, but they maintain the starter formulas until 12 months (the BF group will receive LoF). Subjects are then followed up until 5 years of age.

Enrollment

238 patients

Sex

All

Ages

1 to 7 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

. Healthy newborn infant

Full term infant (= 37 weeks gestation; = 42 weeks gestation)
Birth weight = 2500 g and < 4200 g
Singleton birth
Infant is = 7 days of age at the time of enrollment
For the BF group: The infant's mother has elected to exclusively breastfeed her baby, from enrollment to 4 months of age For the FF groups: The infant's mother has elected to exclusively formula feed her baby, from enrollment to 4 months of age
Having obtained his/her or his/her legal representative's consent

Exclusion criteria

Newborn whose mother's BMI was normal (<20 or = 25) at start of pregnancy
- Newborn whose mother had developed gestational diabetes during pregnancy
- Newborn whose mother has diabetes of type-1 or type-2
- Newborn whose mother smoked > 5 cigarettes / day during pregnancy
- Newborn whose mother had a drug dependence during pregnancy
- Newborn whose mother has a chronic infectious disease
- Newborn whose parents / caregivers cannot be expected to comply with treatment
- Newborn currently participating in another clinical trial