- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02958371
Effect of Choice on Food Pleasure Using fMRI (PLEASIN)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will include one inclusion session (S1), one out-of-the-magnet tasting session (S2), and one fMRI session (S3). For all sessions, study drinks used are fruit-flavored drinks and fruit juices available on the French market. All subjects will undergo the same protocol, except for the choice of the three study drinks that will be done individually.
S1. After the inclusion/exclusion criteria have been verified, the subjects will perform tests to verify their gustatory/olfactory functions (four basic tastes testing and ETOC test). They will then taste study drinks, blindly, and rate perceived pleasantness.
S2. The out-of-the-magnet tasting session will include three parts:
S2.1 - familiarization with the study procedures. Subjects will be placed in conditions mimicking the fMRI session: they will be asked to lie in supine position, head placed in a false head coil, with the gustometer fixed above their mouth and a video screen visible to them to deliver instructions (visual paradigm created using E-Prime). They also will be given a rolling wheel to collect feedback. The rest of the session will be spent in this position. Subjects will then taste the whole range of study drinks (each drink twice, in a randomized order) and rate their pleasantness on visual analog scales (VAS).
S2.2. - learning picture-drink associations. Three drinks will be chosen based on the ratings given during the first part of the session (three equally appreciated, well-liked (VAS score >50) drinks). Subjects will then taste these three drinks repeatedly while observing abstract pictures. The objective of this sequence is to learn 3 picture-drink pairs.
S2.3 - associative learning verification. Subjects will taste each of the three drinks and choose the picture to which each drink has been associated. If they fail once, the S2.2 and S2.3 sequences will be repeated. If they fail to learn associations at the second verification, they will be excluded form the study.
S3. The fMRI session's objective is to study cognitive correlates of choice. Subjects will be placed in a 3Tesla fMRI scanner, with the gustometer, visual screen and rolling wheel available as in the S2. The functional fMRI scan will be done using high-resolution protocol (1,5*1,5*1,8mm) covering prefrontal, subcortical and occipital brain areas. Subjects will undergo 80 tastings. In 50% of tastings, they will view the three previously learned pictures and freely choose one of them, then receive 1ml of the drink associated with that picture. In the other 50% of tastings, the picture-drink pair will be received without the possibility to choose. The "no choice" tastings will be computed according to the results of "choice" tastings so that each drink will be consumed the same amount of times in "choice" and "no choice" context.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Patrick LACARIN
- Phone Number: 04 73 75 15 95
- Email: placarin@chu-clermontferrand.fr
Study Locations
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-
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Clermont-Ferrand, France, 63003
- CHU Clermont-Ferrand
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Principal Investigator:
- Béatrice CLAISE
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- - French resident
- French-speaking
- 18-30 years old
- BMI between 18 and 25kg/m2
- stable weight for at least 3 months
- non-smokers
- favorable results at the study questionnaires (TFEQ, gustatory test, ETOC test)
Exclusion Criteria:
- - unwilling to participate in the study
- minors or adults under guardianship/custody
- subjects without social security
- subjects with a cold
- anosmia or ageusia
- disgust for study products
- allergies to study products
- history of neurologic or psychiatric pathologies
- subjects undergoing exclusion period after another study
- subjects with a counter-indication to undergo an fMRI scan
- subjects on medication
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: fMRI
The study consists in a fMRI experiment intended to observe the effect of the presence of choice on brain activity following consumption of a fruit-flavored drink, compared to the brain activity when the same drink is consumed without choice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BOLD signal recorded in the orbitofrontal cortex
Time Frame: at 2 weeks of study
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at 2 weeks of study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Liking scores measured by the Visual analog scales
Time Frame: at 1 week of study
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at 1 week of study
|
Liking scores measured by the Visual analog scales
Time Frame: at 2 weeks of study
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at 2 weeks of study
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Number of times each drink was chosen by the subjects
Time Frame: at 2 weeks of study
|
at 2 weeks of study
|
BOLD signal recorded in the gustatory cortex
Time Frame: at 2 weeks of study
|
at 2 weeks of study
|
BOLD signal recorded in the insula, frontal operculum and the subcortical regions
Time Frame: at 2 weeks of study
|
at 2 weeks of study
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Béatrice CLAISE, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHU- 287
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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