Caloric Compensation in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03409042
Recruitment Status : Completed
First Posted : January 24, 2018
Last Update Posted : January 25, 2018
Information provided by (Responsible Party):
Centre des Sciences du Goût et de l'Alimentation

Brief Summary:

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.

Condition or disease Intervention/treatment
Self Regulation Eating Behavior Infant Behavior Behavioral: Caloric compensation

Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Caloric Compensation in Infants
Actual Study Start Date : June 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Intervention Details:
  • Behavioral: Caloric compensation
    The investigators have adapted an established within-subject preload paradigm to assess infant's short term caloric compensation. At each studied age, the measure of caloric compensation required two visits at the laboratory on two non-consecutive days. On the first visit, the infants received a fixed amount of a food preload either low or high in energy density. The order of the two preloads was counterbalanced. After a delay (ranging from several hours in the 3-4 months old infants to 25 min in 10.5- and 14.5-month-old infants), the infants were served an ad libitum meal. Weight intakes (g) were assessed by weighing each bottle/bowl before and after consumption.

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   3 Months to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Birch, L.L. and M. Deysher, Conditioned and unconditioned caloric compensation: evidence for self regulation of food intake in young children. Learning and Motivation, 1985. 16: p. 341-355.

Responsible Party: Centre des Sciences du Goût et de l'Alimentation Identifier: NCT03409042     History of Changes
Other Study ID Numbers: PUNCH 1.1.2 (2015-A00014-45)
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre des Sciences du Goût et de l'Alimentation:
Caloric compensation