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

October 31, 2014 updated by: Société des Produits Nestlé (SPN)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

238

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69317
        • Hôpital de la Croix-Rouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 week (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Low protein formula
Low protein formula
Other: Low protein formula
Other Names:
  • LoF
Experimental: Group 2: high protein formula
High protein formula
Other: High protein formula
Other Names:
  • HiF
No Intervention: Group Breastfeeding
Breastfeeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of IGF-1 value
Time Frame: 4 months
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)
Time Frame: 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
DEXA scan as a measure of the body composition
Time Frame: 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
Time Frame: 2 weeks, 4 months and 12 months
amino acids analysis
2 weeks, 4 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Investigators

  • Study Director: Philippe Steenhout, MD, Société des Produits Nestlé (SPN)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 24, 2014

First Submitted That Met QC Criteria

October 31, 2014

First Posted (Estimate)

November 4, 2014

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

October 31, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 05.14.INF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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