NCT02958371

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

October 18, 2016

Last Update Submit

November 4, 2016

Conditions

Healthy Volunteers

Keywords

Functional magnetic resonance imagingTasteFeeding behaviorChoice behavior

Outcome Measures

Primary Outcomes (1)

  • BOLD signal recorded in the orbitofrontal cortex

    at 2 weeks of study

Secondary Outcomes (5)

  • Liking scores measured by the Visual analog scales

    at 1 week of study

  • Liking scores measured by the Visual analog scales

    at 2 weeks of study

  • Number of times each drink was chosen by the subjects

    at 2 weeks of study

  • BOLD signal recorded in the gustatory cortex

    at 2 weeks of study

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

    at 2 weeks of study

Study Arms (1)

fMRI

EXPERIMENTAL

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.

Procedure: fMRIBehavioral: fruit-flavored drink ingestion

Interventions

fMRIPROCEDURE
fMRI
fruit-flavored drink ingestionBEHAVIORAL
fMRI

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- French resident
  • French-speaking
  • 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)

You may not qualify if:

  • \- 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 with a counter-indication to undergo an fMRI scan
  • subjects on medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Béatrice CLAISE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 15 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2016

First Posted

November 8, 2016

Study Start

November 1, 2016

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

FR(1)