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Healthy VolunteersPLEASINNCT02958371

Effect of Choice on Food Pleasure Using fMRI

A study testing fMRI and fruit-flavored drink ingestion in people with Healthy Volunteers, run by University Hospital, Clermont-Ferrand at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
fMRI and fruit-flavored drink ingestion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteFrance
Study dates
Nov 2016to Dec 2017
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 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • - 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)

Who cannot join

  • - 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003

    Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr

    Béatrice CLAISE

Other trials in France

About this study

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.

Read the 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.

Being tested
fMRI, fruit-flavored drink ingestion
Keywords
Functional magnetic resonance imaging, Taste, Feeding behavior, Choice behavior
Medical subject headings
Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fMRIProcedure or surgery

  • fruit-flavored drink ingestionBehavioural

Study groups in NCT02958371
Study groupRoleWhat they receive
fMRIExperimentalThe 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.
Receives: Procedure: fMRI; Behavioral: fruit-flavored drink ingestion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BOLD signal recorded in the orbitofrontal cortex

    Measured: at 2 weeks of study

Secondary outcomes (5)
  1. Liking scores measured by the Visual analog scales

    Measured: at 1 week of study

  2. Liking scores measured by the Visual analog scales

    Measured: at 2 weeks of study

  3. Number of times each drink was chosen by the subjects

    Measured: at 2 weeks of study

  4. BOLD signal recorded in the gustatory cortex

    Measured: at 2 weeks of study

  5. BOLD signal recorded in the insula, frontal operculum and the subcortical regions

    Measured: at 2 weeks of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionSep 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02958371
Sponsor's protocol ID
CHU- 287
Acronym
PLEASIN
Status last verified
Nov 2016
First submitted
18 Oct 2016
Last updated
8 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing fMRI and fruit-flavored drink ingestion in people with Healthy Volunteers, run by University Hospital, Clermont-Ferrand 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 8 Nov 2016. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Patrick LACARIN (04 73 75 15 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BOLD signal recorded in the orbitofrontal cortex (time frame: at 2 weeks of study). 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 8 Nov 2016.

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