Caloric Compensation in Infants

January 24, 2018 updated by: Centre des Sciences du Goût et de l'Alimentation

The aim of this study is, first, to describe the evolution of the caloric compensation ability in infants from 3 to 15 months old and, secondly, to assess the links between changes in the caloric compensation ability and the individual characteristics (adiposity, age, gender, infant's eating behavior) and maternal feeding practices.

Three series of measurements of caloric compensation abitlity were conducted: at 3-4 months old, at 10.5 months old and at 14.5 months old in the laboratory.

In this study, a preload paradigm usually employed in children and adults to measure the caloric compensation ability was adapted to infants below 15 months old. The maternal eating behavior and their feeding practices were measured by questionnaires. The infants' height and weight were measured at the laboratory by trained experimenters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

98

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 11 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Recruitment was conducted using leaflets distributed in health professionals' consulting rooms, an internal database (Chemosens Platform's PanelSens, CNIL n°1148039) and with the help of a recruitment agency.

Description

Inclusion Criteria:

  • no chronic health problem or food allergies
  • not having been fed with hydrolysate formula
  • gestational age ≥ 37 weeks
  • born weight ≥ 2.5kg
  • without having being tube fed at any moment

Exclusion Criteria:

  • infants from diabetic mothers
  • infants from mothers having celiac disease
  • infants from minor parents (<18 years old) were excluded

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COMPX score
Time Frame: one week
Based on intake data, Energy Intakes (EI) were calculated according to caloric composition of the offered foods from the manufacturers. From the EI data, a COMPX score was calculated at each studied age by dividing the difference in EI from meals by the difference in EI from preloads (presented as a percentage). A COMPX score of 100% reflects a perfect caloric compensation.
one week

Collaborators and Investigators

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

Sponsor

Centre des Sciences du Goût et de l'Alimentation

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 (Actual)

June 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (Actual)

January 24, 2018

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PUNCH 1.1.2 (2015-A00014-45)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Infant Behavior

Clinical Trials on Caloric compensation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe