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CompletedNCT03409042Updated Jan 25, 2018

Caloric Compensation in Infants

An observational study in Self Regulation, Eating Behavior and Infant Behavior, sponsored by Centre des Sciences du Goût et de l'Alimentation. Completed. Open to participants aged 3 Months to 11 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-25.

Sponsored by Centre des Sciences du Goût et de l'Alimentation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
98
Ages
3 Months to 11 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Self Regulation
  • Eating Behavior
  • Infant Behavior

Keywords

  • Caloric compensation
03

Who can participate

Ages eligible
3 Months to 11 Months
Sexes eligible
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

Exclusion Criteria:

  • infants from diabetic mothers
  • infants from mothers having celiac disease
  • infants from minor parents (\<18 years old) were excluded
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
98 participants (actual)
Patient registry
No

Interventions

  • BehavioralCaloric 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.

05

What researchers measure

Primary outcomes

  1. COMPX score

    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.

    Time frame: one week

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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.
  • Brugailleres P, Chabanet C, Issanchou S, Schwartz C. Caloric compensation ability around the age of 1 year: Interplay with the caregiver-infant mealtime interaction and infant appetitive traits. Appetite. 2019 Nov 1;142:104382. doi: 10.1016/j.appet.2019.104382. Epub 2019 Jul 23. PubMed 31348973 ↗
  • Brugailleres P, Issanchou S, Nicklaus S, Chabanet C, Schwartz C. Caloric compensation in infants: developmental changes around the age of 1 year and associations with anthropometric measurements up to 2 years. Am J Clin Nutr. 2019 May 1;109(5):1344-1352. doi: 10.1093/ajcn/nqy357. PubMed 30997507 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03409042
Lead sponsor
Centre des Sciences du Goût et de l'Alimentation
Responsible party
Sponsor
First posted
Jan 24, 2018
Start date
Jun 2015
Primary completion
Jul 2017
Completion
Jul 2017
Last update
Jan 25, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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