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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Low protein formula | Experimental | Low protein formula |
|
| Group 2: high protein formula | Experimental | High protein formula |
|
| Group Breastfeeding | No Intervention | Breastfeeding |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low protein formula | Other |
|
| |
| High protein formula |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of IGF-1 value | Analyse the IGF-1 value and compare it | 4 months |
| 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 |
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Inclusion Criteria:
. Healthy newborn infant
Exclusion Criteria:
Newborn whose mother's BMI was normal (<20 or = 25) at start of pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Steenhout, MD | Société des Produits Nestlé (SPN) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Croix-Rouse | Lyon | 69317 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37929831 | Derived | Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2. |
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| Other |
|
|
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 |