Tolerance and Digestibility of a New Formula in Healthy Infants

January 25, 2011 updated by: Lactalis

Study of Tolerance and Lipid Digestibility of a Formula in Healthy 3 Months Infants

The great majority of infants formula contain fats exclusively from vegetable oil. Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an infant formula closer to the nutritional composition of maternal milk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

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
      • Dijon, France, 21078
        • Faculte de Medecine
      • Rennes, France, 35000
        • Hopital Mère-Enfants

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

2 months to 4 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • normal growth;
  • considered as healthy by the investigator according to the medical interrogation and the clinical examination;
  • receiving exclusively infant formula for at least 15 days.
  • without any solid food during the month of the study

Exclusion Criteria:

  • Premature born children or small born weights;
  • Children breast-fed or weaned for less than 15 days;
  • Children with solid food
  • Food allergy, particularly in milk proteins allergy , and lactose intolerance ;
  • Tumoral, inflammatory, cardiac, lung, renal, digestive diseases(syndrome of malabsorption);
  • Digestive pathology previous to the inclusion, in particular infectious (rotavirus, gastroenteritis) or functional symptoms (important stomach pains, colicky) having required a lot of change in formula quality;
  • Children under medical treatment (ex: paracetamol).

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control formula
formula containing only vegetable fats
Dietary supplement: dairy lipids and soluble milk proteins
one month formula supplementation feces are collected during a 3 days period after 15 and 30 days of formula intake
Experimental: new formula
new formula with dairy lipids and soluble milk proteins
Dietary supplement: dairy lipids and soluble milk proteins
one month formula supplementation feces are collected during a 3 days period after 15 and 30 days of formula intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
digestibility of lipids in formula
Time Frame: during the 30d consumption period
lipid content determination in feces during a 3 days period of collection after 15d and 30d of formula intake
during the 30d consumption period

Secondary Outcome Measures

Outcome Measure
Time Frame
tolerance and growth
Time Frame: during the 30d of formula intake
during the 30d of formula intake

Collaborators and Investigators

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

Sponsor

Lactalis

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

November 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 17, 2010

First Posted (Estimate)

August 18, 2010

Study Record Updates

Last Update Posted (Estimate)

January 26, 2011

Last Update Submitted That Met QC Criteria

January 25, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRD-08-15

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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