Conditioning of Caloric Adjustment and Liking in ChildrenNCT02070185
Effect of Energy Density on Liking and on Caloric Adjustment Conditioning
A study testing 2 exposures arm and 7 exposures arm in people with Conditioning of Caloric Adjustment and Liking in Children, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
The main objective is to study, in 8-11 year old children, the influence of energy density conditioning on liking for new flavored beverages and on caloric adjustment after the beverage consumption. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Conditioning of Caloric Adjustment and Liking in Children
- What is being tested?
- 2 exposures arm and 7 exposures arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Jun 2013
- Phase
- Interventional
- 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- regularly ate at the school canteen
- returned signed consent from parents
Who cannot join
- present health problems, food restrictions or food allergies
Trial locations and contacts
1 site in 1 country.
France1 site
Centre des Sciences du Goût et de l'Alimentation
Dijon, Bourgogne-Franche-Comté, 21000
About this study
Official title: Effect of Energy Density on Liking and on Caloric Adjustment Conditioning After Sweet Beverage Exposure in Children Aged 8-11 y
The main objective is to study, in 8-11 year old children, the influence of energy density conditioning on liking for new flavored beverages and on caloric adjustment after the beverage consumption. The stability of the energy conditioning was evaluated after a period without exposure and after an extinction period during which the energy density of the beverages was changed.
- Being tested
- 2 exposures arm, 7 exposures arm
- Keywords
- caloric adjustment,liking, flavour nutrient learning, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 exposures armBehavioural
During this study, children were exposed to 2 flavored sweetened beverages: a high energy version (HE: 150kcal) and a no energy version (NE: 0kcal).
During a 4-wk conditioning period, children were exposed either 2 times to each beverage.
After a 3-wk stability period without exposure, children were exposed 3 times to both beverages in which the association between the flavor and the energy density had been switched (4-wk extinction period).
7 exposures armBehavioural
During this study, children were exposed to 2 flavored sweetened beverages: a high energy version (HE: 150kcal) and a no energy version (NE: 0kcal).
During a 4-wk conditioning period, children were exposed either 7 times to each beverage.
After a 3-wk stability period without exposure, children were exposed 3 times to both beverages in which the association between the flavor and the energy density had been switched (4-wk extinction period).
| Study group | Role | What they receive |
|---|---|---|
| 2 exposures | Experimental | During the conditioning period, the children of this group was exposed only twice to the beverages Receives: Behavioral: 2 exposures arm |
| 7 exposures | Experimental | During the conditioning period, children of this group were exposed exposed 7 times to the beverages Receives: Behavioral: 7 exposures arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flavored beverages liking and preference before the conditioning period (T0)
Liking and preference measurements for the flavored beverages, before the conditioning period.
Measured: Baseline
Secondary outcomes (1)
Energy adjustment before the conditioning period (T0)
Measure of energy intake at the lunch following the beverage consumption, before the conditioning period
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startMar 2013
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conditioning of Caloric Adjustment and Liking in ChildrenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 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
- Collaborators
- European Community (EC), Regional Council of Burgundy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070185
- Sponsor's protocol ID
- Energy
- Status last verified
- Feb 2014
- First submitted
- 17 Feb 2014
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Remy E, Divert C, Rousselot J, Brondel L, Issanchou S, Nicklaus S. Impact of energy density on liking for sweet beverages and caloric-adjustment conditioning in children. Am J Clin Nutr. 2014 Oct;100(4):1052-8. doi: 10.3945/ajcn.114.087452. Epub 2014 Aug 13.
PubMed 25240072
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Energy Density on Liking and on Caloric Adjustment Conditioning After Sweet Beverage Exposure in Children Aged 8-11 y
- ClinicalTrials.gov ID
- NCT02070185
- Acronym / sponsor ID
- Energy
- Keywords
- caloric adjustment,liking, flavour nutrient learning, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- European Community (EC), Regional Council of Burgundy
- Study start
- Mar 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 Feb 2014 (estimated)
- 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 main objective is to study, in 8-11 year old children, the influence of energy density conditioning on liking for new flavored beverages and on caloric adjustment after the beverage consumption. The stability of the energy conditioning was evaluated after a period without exposure and after an extinction period during which the energy density of the beverages was changed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 exposures | Experimental | Behavioral: 2 exposures armDuring the conditioning period, the children of this group was exposed only twice to the beverages |
| 7 exposures | Experimental | Behavioral: 7 exposures armDuring the conditioning period, children of this group were exposed exposed 7 times to the beverages |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- regularly ate at the school canteen
- returned signed consent from parents
Key exclusion criteria (1 listed)
- present health problems, food restrictions or food allergies
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 |
|---|---|---|
| 2 exposures armDuring this study, children were exposed to 2 flavored sweetened beverages: a high energy version (HE: 150kcal) and a no energy version (NE: 0kcal). During a 4-wk conditioning period, children were exposed either 2 times to each beverage. After a 3-wk stability period without exposure, children were exposed 3 times to both beverages in which the association between the flavor and the energy density had been switched (4-wk extinction period). | Behavioural | 2 exposures |
| 7 exposures armDuring this study, children were exposed to 2 flavored sweetened beverages: a high energy version (HE: 150kcal) and a no energy version (NE: 0kcal). During a 4-wk conditioning period, children were exposed either 7 times to each beverage. After a 3-wk stability period without exposure, children were exposed 3 times to both beverages in which the association between the flavor and the energy density had been switched (4-wk extinction period). | Behavioural | 7 exposures |
Primary outcome
Flavored beverages liking and preference before the conditioning period (T0)
Time frame: Baseline
Liking and preference measurements for the flavored beverages, before the conditioning period.
1 secondary outcome
Energy adjustment before the conditioning period (T0)
Time frame: Baseline
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 Feb 2014.
- Derived from this study: PubMed 25240072Remy E, Divert C, Rousselot J, Brondel L, Issanchou S, Nicklaus S. Impact of energy density on liking for sweet beverages and caloric-adjustment conditioning in children. Am J Clin Nutr. 2014 Oct;100(4):1052-8. doi: 10.3945/ajcn.114.087452. Epub 2014 Aug 13.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 exposures arm and 7 exposures arm in people with Conditioning of Caloric Adjustment and Liking in Children, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
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 2 inclusion and 1 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 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Flavored beverages liking and preference before the conditioning period (T0) (time frame: Baseline). 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 NCT02070185, which also lists 1 linked publication.
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 Feb 2014.