Healthy
Conditions
Brief summary
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.
Detailed 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.
Interventions
OTHERLow protein formula
OTHERHigh protein formula
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 7 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of IGF-1 value | 4 months | Analyse the IGF-1 value and compare it |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hormonal profile analysis (Insulin, C-peptide, Glucose, octanoyl ghrelin, Leptin and IGF-1) | 2 weeks, 4 months and 12 months | The following markers will be measured: Insulin, C-peptide, Glucose, octanoyl ghrelin, Leptin and IGF-1 (IGF-1 at 4 months constitutes the primary outcome of this trial). |
| DEXA scan as a measure of the body composition | 2 weeks, 4 months and 12 months | Measure of the Fat Mass (FM) gain and at the variations in Lean Mass (LM) during the first year of age. |
| aminogramm analysis | 2 weeks, 4 months and 12 months | amino acids analysis |
Countries
France
Outcome results
None listed