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