Effect of Choice on Food Pleasure Using fMRI (PLEASIN)

November 4, 2016 updated by: University Hospital, Clermont-Ferrand
Previous studies have suggested that consumers who can choose what to eat could find food more pleasant, and consume more of that food, than when in absence of choice. However cognitive mechanisms that could explain the effect of choice have not been investigated. 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. It is suggested that consumers will appreciate drinks they chose better, and that the activity in gustatory and reward regions will change accordingly to changes in declared food pleasure.

Study Overview

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

Interventional

Enrollment (Anticipated)

55

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 Contact

Study Locations

      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand
        • Principal Investigator:
          • Béatrice CLAISE

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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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

  • 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.

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
at 2 weeks of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Liking scores measured by the Visual analog scales
Time Frame: at 1 week of study
at 1 week of study
Liking scores measured by the Visual analog scales
Time Frame: at 2 weeks of study
at 2 weeks of study
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Béatrice CLAISE, University Hospital, Clermont-Ferrand

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

November 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 4, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

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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