HealthyNCT03095833
Food Intake Decisions
A study testing Odors, Visual stimulation and Experimental Task in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Odors, Visual stimulation and Experimental Task
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2015to 19 Nov 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy or Prader-Willi
- right handed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Food Decisions and Reward System: Modulation by Olfaction and Taste
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.
- Conditions
- Healthy
- Being tested
- Odors, Visual stimulation, Experimental Task, Blood tests, Questionnaires and test administered
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OdorsOther
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.
Visual stimulationOther
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.
Experimental TaskOther
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.
Blood testsOther
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).
Questionnaires and test administeredOther
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.
fMRIOther
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.
Odors 2Other
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.
ImagesOther
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.
Experimental Task fMRIOther
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.
Genotyping for susceptibility to β-iononeOther
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.
Experimental Task 2Other
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 group | Role | What they receive |
|---|---|---|
| Influence of cognitive biases on food intake | Other | 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. Receives: 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 | Other | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain activity related to the perception of food odors and flavor
functional magnetic resonance imaging data
Measured: Hour 1
Secondary outcomes (2)
behavioral ratings of odor/flavor valuation by participants
behavioral ratings of odor/flavor valuation by participants
Measured: Hour 1
blood alcohol level post experiment
reference value for file information
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start27 Feb 2015
- Primary completion19 Nov 2015
- Study completion19 Nov 2015
Why it stopped: Insufficient on-site staff to manage study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline DEMILY, MD, Principal investigator, CH le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095833
- Sponsor's protocol ID
- 69HCL16_0681
- Status last verified
- Nov 2017
- First submitted
- 24 Mar 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Decisions and Reward System: Modulation by Olfaction and Taste
- ClinicalTrials.gov ID
- NCT03095833
- Acronym / sponsor ID
- 69HCL16_0681
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient on-site staff to manage study
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 Feb 2015 (actual)
- Primary completion
- 19 Nov 2015 (actual)
- Study completion
- 19 Nov 2015 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influence of cognitive biases on food intake | Other | Other: Odors, Other: Visual stimulation, Other: Experimental Task, Other: Blood tests, Other: Questionnaires and test administered, Other: fMRIDetermine 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. |
| Modulation of the floral flavor of a wine | Other | 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 2Highlight 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy or Prader-Willi
- right handed
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OdorsFour 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 | Influence of cognitive biases on food intake |
| Visual stimulationConcerning 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 | Influence of cognitive biases on food intake |
| Experimental TaskThe 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 | Influence of cognitive biases on food intake |
| Blood testsBefore 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 | Influence of cognitive biases on food intake, Modulation of the floral flavor of a wine |
| Questionnaires and test administeredThe 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 | Influence of cognitive biases on food intake, Modulation of the floral flavor of a wine |
| fMRIThe 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 | Influence of cognitive biases on food intake, Modulation of the floral flavor of a wine |
| Odors 2To 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 | Modulation of the floral flavor of a wine |
| ImagesThe 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 | Modulation of the floral flavor of a wine |
| Experimental Task fMRIFor 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 | Modulation of the floral flavor of a wine |
| Genotyping for susceptibility to β-iononeSampling 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 | Modulation of the floral flavor of a wine |
| Experimental Task 2The 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. | Other | Modulation of the floral flavor of a wine |
Primary outcome
brain activity related to the perception of food odors and flavor
Time frame: Hour 1
functional magnetic resonance imaging data
2 secondary outcomes
behavioral ratings of odor/flavor valuation by participants
Time frame: Hour 1
blood alcohol level post experiment
Time frame: 10 minutes
Results and safety
The study was stopped early (reason given: Insufficient on-site staff to manage study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline DEMILY, MD principal investigator
CH le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Odors, Visual stimulation and Experimental Task in people with Healthy, run by Hospices Civils de Lyon 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 28 Nov 2017. 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?
The study was stopped early (reason given: Insufficient on-site staff to manage study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain activity related to the perception of food odors and flavor (time frame: Hour 1). 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 28 Nov 2017.