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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03409042
Other study ID # PUNCH 1.1.2 (2015-A00014-45)
Secondary ID
Status Completed
Phase N/A
First received January 18, 2018
Last updated January 24, 2018
Start date June 2015
Est. completion date July 2017

Study information

Verified date January 2018
Source Centre des Sciences du Goût et de l'Alimentation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Months to 11 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre des Sciences du Goût et de l'Alimentation

References & Publications (1)

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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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. one week
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