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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Low protein formula
* Other: High protein formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Low protein formula<br>Low protein formula | Other: Low protein formula<br> <br> * Other names: LoF;|
| Experimental: Group 2: high protein formula<br>High protein formula | Other: High protein formula<br> <br> * Other names: HiF;|
| No Intervention: Group Breastfeeding<br>Breastfeeding | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of IGF-1 value | Analyse the IGF-1 value and compare it | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormonal profile analysis (Insulin, C-peptide, Glucose, octanoyl ghrelin, Leptin and IGF-1) | 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). | 2 weeks, 4 months and 12 months | 
| DEXA scan as a measure of the body composition | Measure of the Fat Mass (FM) gain and at the variations in Lean Mass (LM) during the first year of age. | 2 weeks, 4 months and 12 months | 
| aminogramm analysis | amino acids analysis | 2 weeks, 4 months and 12 months |