Effect of Choice on Food Pleasure Using fMRI

Healthy Volunteers Clinical Trial

— PLEASIN  

Official title:

Effect of Choice on Food Pleasure Using fMRI

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02958371
• Other study ID #: CHU- 287
• Status: Not yet recruiting
• Phase: N/A
• First received: October 18, 2016
• Last updated: November 4, 2016
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 15 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Procedure:
• fMRI

Behavioral:
• fruit-flavored drink ingestion

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	UMR 914 PNCA – AgroParisTech, INRA, Université Paris-Saclay, UR370 QuaPA AgroRésonance – INRA Saint-Génès-Champanelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD signal recorded in the orbitofrontal cortex		at 2 weeks of study	Yes
Secondary	Liking scores measured by the Visual analog scales		at 1 week of study	Yes
Secondary	Liking scores measured by the Visual analog scales		at 2 weeks of study	Yes
Secondary	Number of times each drink was chosen by the subjects		at 2 weeks of study	Yes
Secondary	BOLD signal recorded in the gustatory cortex		at 2 weeks of study	Yes
Secondary	BOLD signal recorded in the insula, frontal operculum and the subcortical regions		at 2 weeks of study	Yes