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

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.

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