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

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT02282488
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2009-06
• Study Completion: 2012-12
• Status Verified: 2014-10
• Study First Submitted: 2014-10-24
• Study First Submitted QC: 2014-10-31
• Last Update Submitted: 2014-10-31
• Study First Posted: 2014-11-04
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Analysis of IGF-1 value	4 months	Analyse the IGF-1 value and compare it

Secondary Outcome Measures

Name	Time	Method
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.
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).
aminogramm analysis	2 weeks, 4 months and 12 months	amino acids analysis

Trial Locations

Locations (1)

Hôpital de la Croix-Rouse; 🇫🇷 Lyon, France