Self RegulationNCT03409042
Caloric Compensation in Infants
An observational study of Self Regulation and Eating Behavior, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement.
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… Read more about this study
- Who is it for?
- Ages 3 to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Self Regulation, Eating Behavior, Infant Behavior
- What is being tested?
- Caloric compensation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- infants from diabetic mothers
- infants from mothers having celiac disease
- infants from minor parents (<18 years old) were excluded
About this study
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.
- Conditions
- Self Regulation, Eating Behavior, Infant Behavior
- Being tested
- Caloric compensation
- Keywords
- Caloric compensation
- Medical subject headings
- Self-Control, Feeding Behavior, Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric compensationBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study startJun 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Self RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409042
- Sponsor's protocol ID
- PUNCH 1.1.2 (2015-A00014-45)
- Status last verified
- Jan 2018
- First submitted
- 18 Jan 2018
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31348973Brugailleres 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caloric Compensation in Infants
- ClinicalTrials.gov ID
- NCT03409042
- Acronym / sponsor ID
- PUNCH 1.1.2 (2015-A00014-45)
- Conditions
- Self Regulation, Eating Behavior, Infant Behavior
- Keywords
- Caloric compensation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- infants from diabetic mothers
- infants from mothers having celiac disease
- infants from minor parents (<18 years old) were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric compensationThe 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. | Behavioural | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- BackgroundBirch, 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.
- Derived from this study: PubMed 31348973Brugailleres 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.
- Derived from this study: PubMed 30997507Brugailleres 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Self Regulation and Eating Behavior, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMPX score (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03409042, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018; AzTrials last refreshed its copy on 28 Oct 2026.