- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01790191
Comparison of Effect of Repeated Exposure, Flavor-Flavor and Flavor-Nutrient Learning on Vegetable Acceptance in Infants (T221_HabEat)
February 13, 2013 updated by: Centre des Sciences du Goût et de l'Alimentation
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Dijon, France, 21000
- Centre des Sciences du Goût et de l'Alimentation
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months to 8 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy infants, aged between 4 and 8 months old, not yet introduced to complementary foods
Exclusion Criteria:
- Infants with food allergies, with chronic health problem, or born before 36 weeks of gestational age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RE group
Repeated consumption of artichoke purée.
This group was exposed to basic artichoke puree from Exposure 1 to 10 (E1 to E10)
|
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).
|
Active Comparator: FFL group
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).
|
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).
|
Active Comparator: FNL group
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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Participants will be followed for an average duration of 8 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food Liking
Time Frame: Participants will be followed for an average duration of 8 months
|
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)
|
Participants will be followed for an average duration of 8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sophie Nicklaus, PhD, Centre des Sciences du Goût et de l'Alimentation INRA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
February 6, 2013
First Submitted That Met QC Criteria
February 11, 2013
First Posted (Estimate)
February 13, 2013
Study Record Updates
Last Update Posted (Estimate)
February 15, 2013
Last Update Submitted That Met QC Criteria
February 13, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- T221_HabEat
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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