Effect of Formula on Growth of Infants From Overweight or Obese Mothers

March 25, 2015 updated by: Société des Produits Nestlé (SPN)

Effect of Protein Levels and Caloric Density on the Growth of Formula Fed Infants From Overweight or Obese Mothers

The purpose of this study is to determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

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

  • Chile
      • Temuco, Chile
        • Departamento de Medicina Interna, University de la Frontera

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

3 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy newborn infant
  • birth weight between 2500g and 4800g
  • singleton birth
  • mother's BMI before pregnancy was between 26 and 25
  • for the breastfeeding group: mother has elected to exclusively breastfeed her baby from birth to at least 6 months of age
  • for the formula groups: mother has elected to exclusively formula feed her baby from 3 to 6 months of age
  • having obtained signed informed consent of legal representative

Exclusion Criteria:

  • body weight smaller than 5th percentile for that gestational age
  • newborn whose mother has diabetes
  • newborn whose mother has a drug dependence during pregnancy
  • newborn currently participating in another 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
Placebo Comparator: 1
Standard infant formula
Other: standard infant formula
standard infant formula given from 3 to 12 months of age, as per standard requirement
Experimental: 2
Test formula
Other: Test formula
Test formula with different protein and calorie content than standard formula, given from 3 to 12 months of age. As per standard requirement.
No Intervention: 3
Breastfeeding reference group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean weight gain
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
blood test assessments; body composition, bone density
Time Frame: 9 months
9 months

Collaborators and Investigators

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

Sponsor

Société des Produits Nestlé (SPN)

Investigators

  • Principal Investigator: Jaime Inostroza, PhD, Universidad de La Frontera

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimate)

January 12, 2009

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05.29.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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