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Food Intake Decisions

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ClinicalTrials.gov Identifier: NCT03095833
Recruitment Status : Terminated (Insufficient on-site staff to manage study)
First Posted : March 30, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE March 24, 2017
First Posted Date  ICMJE March 30, 2017
Last Update Posted Date November 28, 2017
Actual Study Start Date  ICMJE February 27, 2015
Actual Primary Completion Date November 19, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
brain activity related to the perception of food odors and flavor [ Time Frame: Hour 1 ]
functional magnetic resonance imaging data
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03095833 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
  • behavioral ratings of odor/flavor valuation by participants [ Time Frame: Hour 1 ]
    behavioral ratings of odor/flavor valuation by participants
  • blood alcohol level post experiment [ Time Frame: 10 minutes ]
    reference value for file information
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Food Intake Decisions
Official Title  ICMJE Food Decisions and Reward System: Modulation by Olfaction and Taste
Brief Summary Functional Magnetic resonance study on the effect of cognitive context variables on the perception and valuation of food odorants and flavor. The study is composed of two experiments; in a first experiment we address the question of how valuation of food odors are modulated by 3 cognitive conditions (indulgence, healthy, and neutral). Food odors are delivered using a custom-made olfactometer. Here we hypothesize that cognitive regulation can modulate the primary sensory processing of food odors. We expect that cortical regions related with valuation and cognitive regulation such as the ventromedial prefrontal cortex and the dorsolateral prefrontal cortex operate the modulation of primary olfactory cortex and amygdala. In a second experiment, we aim to reveal the brain areas involved in integrating food color cues with odor and taste stimuli. Here we hypothesize that color cues are capable of biasing flavor attributes of food (flavor intensity), and that this bias occurs at different cortical areas commonly associate with multisensory integration such as the orbitofrontal cortex, insula, amygdala and hippocampus.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Other: Odors

    Four odors are available: "milk chocolate", "dark chocolate", "pineapple" and "apricot".

    In addition, a neutral odor will be used "clean air", a control odor transmitted during the task by the olfactometer in the same way as the other 4 odors, the only variant being that no odor will be deposited in the U-tube containing the smells. The images corresponding to the odors will be displayed after the odor has been proposed.

  • Other: Visual stimulation
    Concerning behavioral passes, the subjects will be in front of a computer screen on which the task will be presented. For fMRI passes, the visual stimulation of the participant is done by a mirror system placed about 10 cm from the participant's eyes, allowing him to watch a translucent screen on which the visual stimuli are projected. The latter have an intensity similar to that of television images, and therefore below the maximum permitted by labor legislation. The stimuli will be projected via a video projector located at the back of the imager.
  • Other: Experimental Task
    The olfactory sensitivity and the olfactory identification capacities of the subjects will be evaluated using the ETOC test. Subjects will have to define his state of hunger/satiety thanks to a questionnaire of hunger. Finally, subjects should assess the hedonic nature of the odor and the edibility of the odor source. The task to be performed will be the same for the behavioral study as for the imaging study. The subject will receive instruction from the following three: "indulge yourself", the subject must think of the desire to eat the food that will be presented to him in olfactory and visual form; "Be natural," the subject must act as naturally as possible; Or "hold back," the subject must distance themselves from their desire to eat and control themselves. In a second step, an odor will be presented for 5 seconds. This will be based on the subject's inspiration, then an image associated with the odor will be presented for two seconds.
  • Other: Blood tests
    Before and after the imaging examination, a blood sample will be taken by a medical imaging manipulator affiliated with the CERMEP whose actions will be remunerated in accordance with the usual hygiene and safety rules. The samples taken will then be annotated with the subject code and kept at the CERMEP. The volume of ghrelin sampling is 5 ml (10 ml for two samples). The volume of the leptin is 5 ml (ie 10 ml for two samples).
  • Other: Questionnaires and test administered
    The proposed questionnaires respond to all ethical aspects established by international and national standards to undertake studies on human subjects. Two types of questionnaires will be used in this experiment: Inclusion of the Subjects and Exploratory Tests.
  • Other: fMRI
    The purpose of the imaging part is to determine how high-level cognitive control (the setpoint) can affect the price of a food and the olfactory and visual perception of these foods in healthy subjects and Prader-Willi patients.
  • Other: Odors 2
    To modify the floral character of the wine used, the investigators will use the β-ionone odorant molecule (4 (2,6,6-trimethyl-1-cyclohexenyl) -3-buten-2-one (CAS number 14901-07-6) Purity ≥97.0% (Fluka) This molecule is commonly found in wines with a violet odor.
  • Other: Images
    The visual stimulation of the subject will be done by a system of mirrors placed about 10 cm from the subject's eyes allows him to look at a translucent screen behind the MRI scanner and on which the visual stimuli are projected.
  • Other: Experimental Task fMRI
    For each test the subjects will receive at the same time an image on the screen and a sample of wine (2 ml) delivered in the mouth of the subject thanks to the system of programmable pumps.
  • Other: Genotyping for susceptibility to β-ionone
    Sampling will be done by the subject himself by scratching and firmly pressing into the oral cavity, specifically at the cheeks and tongue for one minute, being careful not to touch the teeth and gums.
  • Other: Experimental Task 2
    The investigators will determine how perceptual judgments are modulated by cross-modal stimuli, as well as metacognitive judgments (how individuals judge their own sensory performance). In addition, they will determine how perceptual judgments are modified in the context of group decisions and how language influences performance.
Study Arms  ICMJE
  • Influence of cognitive biases on food intake
    Determine how high-level cognitive control can affect the price to pay for a food and the olfactory and visual perception of these foods in healthy subjects and Prader-Willi patients.
    Interventions:
    • Other: Odors
    • Other: Visual stimulation
    • Other: Experimental Task
    • Other: Blood tests
    • Other: Questionnaires and test administered
    • Other: fMRI
  • Modulation of the floral flavor of a wine
    Highlight the brain regions involved in the visual bias related to the intensity of a wine's dress combined with the floral character evaluation of its flavor.
    Interventions:
    • Other: Blood tests
    • Other: Questionnaires and test administered
    • Other: fMRI
    • Other: Odors 2
    • Other: Images
    • Other: Experimental Task fMRI
    • Other: Genotyping for susceptibility to β-ionone
    • Other: Experimental Task 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 24, 2017)
65
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 19, 2015
Actual Primary Completion Date November 19, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy or Prader-Willi
  • right handed

Exclusion Criteria:

  • Nursing or pregnant women
  • undergoing medical treatment
  • Having known olfactory disorder
  • neurological or psychiatric history
  • all pertinent conditions according to the use of magnetic resonance imaging.
  • anosmia (partial/total)
  • neurological, psychological or other disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03095833
Other Study ID Numbers  ICMJE 69HCL16_0681
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Caroline DEMILY, MD CH le Vinatier
PRS Account Hospices Civils de Lyon
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP