Effect of the Level of Dietary Protein on the Infant Hormonal Profile and Body Composition
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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Lyon, Frankrig, 69317
- Hôpital de la Croix-Rouse
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Group 1: Low protein formula
Low protein formula
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Andre navne:
|
|
Eksperimentel: Group 2: high protein formula
High protein formula
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Andre navne:
|
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Ingen indgriben: Group Breastfeeding
Breastfeeding
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Analysis of IGF-1 value
Tidsramme: 4 months
|
Analyse the IGF-1 value and compare it
|
4 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hormonal profile analysis (Insulin, C-peptide, Glucose, octanoyl ghrelin, Leptin and IGF-1)
Tidsramme: 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).
|
2 weeks, 4 months and 12 months
|
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DEXA scan as a measure of the body composition
Tidsramme: 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.
|
2 weeks, 4 months and 12 months
|
|
aminogramm analysis
Tidsramme: 2 weeks, 4 months and 12 months
|
amino acids analysis
|
2 weeks, 4 months and 12 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Philippe Steenhout, MD, Société des Produits Nestlé (SPN)
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 05.14.INF
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