Development of Eating BehaviorT221_HabEatNCT01790191
Comparison of Effect of Repeated Exposure, Flavor-Flavor and Flavor-Nutrient Learning on Vegetable Acceptance in Infants
A study testing Repeated consumption of basic artichoke purée., Repeated consumption of sweet artichoke purée. and Repeated exposure to fat artichoke purée. in people with Development of Eating Behavior, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
This study aims at comparing learning mechanisms to increase vegetable acceptance in infants at complementary feeding, namely repeated exposure (RE), flavor-flavor learning (FFL) and flavor-nutrient learning (FNL); measuring the stability of the learning effect; and examining the impact of infants' feeding history on… Read more about this study
- Who is it for?
- Ages 4 to 8 monthsHealthy volunteers can take part
- Conditions the study is for
- Development of Eating Behavior
- What is being tested?
- Repeated consumption of basic artichoke purée., Repeated consumption of sweet artichoke purée. and Repeated exposure to fat artichoke purée.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Feb 2012
- 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 4 to 8 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants, aged between 4 and 8 months old, not yet introduced to complementary foods
Who cannot join
- Infants with food allergies, with chronic health problem, or born before 36 weeks of gestational age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Repeated Exposure, Flavor-Flavor Learning and Flavor-Nutrient Learning on Vegetable Acceptance in Weaning Age Infants
This study aims at comparing learning mechanisms to increase vegetable acceptance in infants at complementary feeding, namely repeated exposure (RE), flavor-flavor learning (FFL) and flavor-nutrient learning (FNL); measuring the stability of the learning effect; and examining the impact of infants' feeding history on vegetable acceptance.
- Conditions
- Development of Eating Behavior
- Being tested
- Repeated consumption of basic artichoke purée., Repeated consumption of sweet artichoke purée., Repeated exposure to fat artichoke purée.
- Keywords
- Children, Eating behaviour, Intake, Liking, Conditioned liking, Flavour, Nutrient, Vegetable
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated consumption of basic artichoke purée.Behavioural
In this conditioning trial, the effect of repeated consumption of different types of artichoke purée was studied. In Arm 1, participants were repeatedly exposed to basic artichoke purée. In Arm 2, participants were repeatedly exposed to sweet artichoke purée. In Arm 3, participants were repeatedly exposed to fat artichoke purée. Change in intake and liking of basic artichoke purée was evaluated at baseline and after 10 exposures to artichoke purée ; and at 3 follow-ups: after 2 weeks (FU2W), after 3 months (FU3M) and after 6 months (FU6M).
Repeated consumption of sweet artichoke purée.Behavioural
In this conditioning trial, the effect of repeated consumption of different types of artichoke purée was studied. In Arm 1, participants were repeatedly exposed to basic artichoke purée. In Arm 2, participants were repeatedly exposed to sweet artichoke purée. In Arm 3, participants were repeatedly exposed to fat artichoke purée. Change in intake and liking of basic artichoke purée was evaluated at baseline and after 10 exposures to artichoke purée ; and at 3 follow-ups: after 2 weeks (FU2W), after 3 months (FU3M) and after 6 months (FU6M).
Repeated exposure to fat artichoke purée.Behavioural
In this conditioning trial, the effect of repeated consumption of different types of artichoke purée was studied. In Arm 1, participants were repeatedly exposed to basic artichoke purée. In Arm 2, participants were repeatedly exposed to sweet artichoke purée. In Arm 3, participants were repeatedly exposed to fat artichoke purée. Change in intake and liking of basic artichoke purée was evaluated at baseline and after 10 exposures to artichoke purée ; and at 3 follow-ups: after 2 weeks (FU2W), after 3 months (FU3M) and after 6 months (FU6M).
| Study group | Role | What they receive |
|---|---|---|
| RE group | Experimental | Repeated consumption of artichoke purée. This group was exposed to basic artichoke puree from Exposure 1 to 10 (E1 to E10) Receives: Behavioral: Repeated consumption of basic artichoke purée. |
| FFL group | Active comparator | Repeated consumption of artichoke purée. This group (Flavor-flavor learning group) was exposed to sweet artichoke puree from Exposure 1 to 10 (E1 to E10). Receives: Behavioral: Repeated consumption of sweet artichoke purée. |
| FNL group | Active comparator | Repeated consumption of artichoke purée. This group (Flavor-nutrient learning group) was exposed to fat, energy-dense artichoke puree from Exposure 1 to 10 (E1 to E10). Receives: Behavioral: Repeated exposure to fat artichoke purée. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
Intake of artichoke puree at baseline and at different time points of the experiment (Exposures 1 to 10 defined as E1, E2, E3, E4, E5 ,E6, E7, E8, E9, E10, Postexposure, FU2W, FU3M, FU6M)
Measured: Participants will be followed for an average duration of 8 months
Secondary outcomes (1)
Food Liking
Evolution of Liking of artichoke puree at baseline and at different time points of the experiment (Exposures 1 to 10 defined as E1, E2, E3, E4, E5 ,E6, E7, E8, E9, E10, Postexposure, FU2W, FU3M, FU6M)
Measured: Participants will be followed for an average duration of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startOct 2010
- Primary completionJul 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development of Eating BehaviorStudies 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
- 100 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 Union
- Responsible party
- Sponsor
- Investigators
- Sophie Nicklaus, PhD, Principal investigator, Centre des Sciences du Goût et de l'Alimentation INRA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790191
- Sponsor's protocol ID
- T221_HabEat
- Acronym
- T221_HabEat
- Status last verified
- Feb 2013
- First submitted
- 6 Feb 2013
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Repeated Exposure, Flavor-Flavor Learning and Flavor-Nutrient Learning on Vegetable Acceptance in Weaning Age Infants
- ClinicalTrials.gov ID
- NCT01790191
- Acronym / sponsor ID
- T221_HabEat / T221_HabEat
- Conditions
- Development of Eating Behavior
- Keywords
- Children, Eating behaviour, Intake, Liking, Conditioned liking, Flavour, Nutrient, Vegetable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- European Union
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 13 Feb 2013 (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.
This study aims at comparing learning mechanisms to increase vegetable acceptance in infants at complementary feeding, namely repeated exposure (RE), flavor-flavor learning (FFL) and flavor-nutrient learning (FNL); measuring the stability of the learning effect; and examining the impact of infants' feeding history on vegetable acceptance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RE group | Experimental | Behavioral: Repeated consumption of basic artichoke purée.Repeated consumption of artichoke purée. This group was exposed to basic artichoke puree from Exposure 1 to 10 (E1 to E10) |
| FFL group | Active comparator | Behavioral: Repeated consumption of sweet artichoke purée.Repeated consumption of artichoke purée. This group (Flavor-flavor learning group) was exposed to sweet artichoke puree from Exposure 1 to 10 (E1 to E10). |
| FNL group | Active comparator | Behavioral: Repeated exposure to fat artichoke purée.Repeated consumption of artichoke purée. This group (Flavor-nutrient learning group) was exposed to fat, energy-dense artichoke puree from Exposure 1 to 10 (E1 to E10). |
Who may qualify
- Ages
- 4 to 8 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy infants, aged between 4 and 8 months old, not yet introduced to complementary foods
Key exclusion criteria (1 listed)
- Infants with food allergies, with chronic health problem, or born before 36 weeks of gestational age
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 |
|---|---|---|
| Repeated consumption of basic artichoke purée.In this conditioning trial, the effect of repeated consumption of different types of artichoke purée was studied. In Arm 1, participants were repeatedly exposed to basic artichoke purée. In Arm 2, participants were repeatedly exposed to sweet artichoke purée. In Arm 3, participants were repeatedly exposed to fat artichoke purée. Change in intake and liking of basic artichoke purée was evaluated at baseline and after 10 exposures to artichoke purée ; and at 3 follow-ups: after 2 weeks (FU2W), after 3 months (FU3M) and after 6 months (FU6M). | Behavioural | RE group |
| Repeated consumption of sweet artichoke purée.In this conditioning trial, the effect of repeated consumption of different types of artichoke purée was studied. In Arm 1, participants were repeatedly exposed to basic artichoke purée. In Arm 2, participants were repeatedly exposed to sweet artichoke purée. In Arm 3, participants were repeatedly exposed to fat artichoke purée. Change in intake and liking of basic artichoke purée was evaluated at baseline and after 10 exposures to artichoke purée ; and at 3 follow-ups: after 2 weeks (FU2W), after 3 months (FU3M) and after 6 months (FU6M). | Behavioural | FFL group |
| Repeated exposure to fat artichoke purée.In this conditioning trial, the effect of repeated consumption of different types of artichoke purée was studied. In Arm 1, participants were repeatedly exposed to basic artichoke purée. In Arm 2, participants were repeatedly exposed to sweet artichoke purée. In Arm 3, participants were repeatedly exposed to fat artichoke purée. Change in intake and liking of basic artichoke purée was evaluated at baseline and after 10 exposures to artichoke purée ; and at 3 follow-ups: after 2 weeks (FU2W), after 3 months (FU3M) and after 6 months (FU6M). | Behavioural | FNL group |
Primary outcome
Food intake
Time frame: Participants will be followed for an average duration of 8 months
Intake of artichoke puree at baseline and at different time points of the experiment (Exposures 1 to 10 defined as E1, E2, E3, E4, E5 ,E6, E7, E8, E9, E10, Postexposure, FU2W, FU3M, FU6M)
1 secondary outcome
Food Liking
Time frame: Participants will be followed for an average duration of 8 months
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 15 Feb 2013.
- Web site for the main research project funded by the European UnionLink provided by the sponsor.
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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.
Sophie Nicklaus, PhD principal investigator
Centre des Sciences du Goût et de l'Alimentation INRA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated consumption of basic artichoke purée., Repeated consumption of sweet artichoke purée. and Repeated exposure to fat artichoke purée. in people with Development of Eating Behavior, 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 1 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 15 Feb 2013. 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?
Food intake (time frame: Participants will be followed for an average duration of 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2013.