NCT02282488

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 1 Day – 7 Days
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Low protein formula
OTHER	High protein formula

Timeline

• Start date: 2006-04-01
• Primary completion: 2009-06-01
• Completion: 2012-12-01
• First posted: 2014-11-04
• Last updated: 2014-11-04

Locations

1 site across 1 country: France