Healthy VolunteerNeuroFoodNCT02841410
Neuroeconomic Approach of Food Nutritionnal Assesment
A study testing Magnetic Resonance Imaging in people with Healthy Volunteer, run by University Hospital, Grenoble.
Trial summary
This fMRI study evaluated the cognitive mechanisms and the cerebral substrate of decision making when evaluating the healthiness of food products with nutritional information displayed either with a Traffic Light system, a colored nutritional label, and a Guideline Daily Amount system, a numeric label. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- signed informed consent
- medical exam completed before participation in reserach
- to be insured under the social security system
- to be an adult between 18 and 50 years
Who cannot join
- counter-argument to magnetic field exposure
- neurological or psychiatric disorder including eating disorders
- had
About this study
Official title: Neural Networks of Decision Making Processes Triggered by Food Labels
This fMRI study evaluated the cognitive mechanisms and the cerebral substrate of decision making when evaluating the healthiness of food products with nutritional information displayed either with a Traffic Light system, a colored nutritional label, and a Guideline Daily Amount system, a numeric label.
Read the detailed description
The investigators postulated that Traffic Light label would recruit emotion processes and activation of subjacent cerebral networks.
On the contrary, the nutritional information presented in a Guideline Daily Amount label, would recruit, due to its numeric format and higher complexity, supplementary cognitive processes and activation of related brain regions.
- Conditions
- Healthy Volunteer
- Being tested
- Magnetic Resonance Imaging
- Keywords
- Food, Emotion, Health, Nutrition, Heuristic, Reasoning, Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Other | Not described Receives: Other: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of cerebral areas's activation
MRI
Measured: About two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Krainik, Principal investigator, Grenoble Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841410
- Sponsor's protocol ID
- 38RC14.322
- Acronym
- NeuroFood
- Status last verified
- Jul 2016
- First submitted
- 5 Jul 2016
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Arana FS, Parkinson JA, Hinton E, Holland AJ, Owen AM, Roberts AC. Dissociable contributions of the human amygdala and orbitofrontal cortex to incentive motivation and goal selection. J Neurosci. 2003 Oct 22;23(29):9632-8. doi: 10.1523/JNEUROSCI.23-29-09632.2003.
PubMed 14573543Aschemann-Witzel J, Grunert KG, van Trijp HC, Bialkova S, Raats MM, Hodgkins C, Wasowicz-Kirylo G, Koenigstorfer J. Effects of nutrition label format and product assortment on the healthfulness of food choice. Appetite. 2013 Dec;71:63-74. doi: 10.1016/j.appet.2013.07.004. Epub 2013 Jul 23.
PubMed 23891558Basten U, Biele G, Heekeren HR, Fiebach CJ. How the brain integrates costs and benefits during decision making. Proc Natl Acad Sci U S A. 2010 Dec 14;107(50):21767-72. doi: 10.1073/pnas.0908104107. Epub 2010 Nov 30.
PubMed 21118983Beaver JD, Lawrence AD, van Ditzhuijzen J, Davis MH, Woods A, Calder AJ. Individual differences in reward drive predict neural responses to images of food. J Neurosci. 2006 May 10;26(19):5160-6. doi: 10.1523/JNEUROSCI.0350-06.2006.
PubMed 16687507Birch LL. Development of food preferences. Annu Rev Nutr. 1999;19:41-62. doi: 10.1146/annurev.nutr.19.1.41.
PubMed 10448516Borgmeier I, Westenhoefer J. Impact of different food label formats on healthiness evaluation and food choice of consumers: a randomized-controlled study. BMC Public Health. 2009 Jun 12;9:184. doi: 10.1186/1471-2458-9-184.
PubMed 19523212Braeutigam S, Rose SP, Swithenby SJ, Ambler T. The distributed neuronal systems supporting choice-making in real-life situations: differences between men and women when choosing groceries detected using magnetoencephalography. Eur J Neurosci. 2004 Jul;20(1):293-302. doi: 10.1111/j.1460-9568.2004.03467.x.
PubMed 15245501Burton S, Andrews JC. (1996), Age, Product Nutrition, and Label Format Effects on Consumer Perceptions and Product Evaluations. Journal of Consumer Affairs, 30, 68-89.
Campos S, Doxey J, Hammond D. Nutrition labels on pre-packaged foods: a systematic review. Public Health Nutr. 2011 Aug;14(8):1496-506. doi: 10.1017/S1368980010003290. Epub 2011 Jan 18.
PubMed 21241532Carelli RM, King VC, Hampson RE, Deadwyler SA. Firing patterns of nucleus accumbens neurons during cocaine self-administration in rats. Brain Res. 1993 Oct 29;626(1-2):14-22. doi: 10.1016/0006-8993(93)90557-4.
PubMed 8281424De Neys W, Glumicic T. Conflict monitoring in dual process theories of thinking. Cognition. 2008 Mar;106(3):1248-99. doi: 10.1016/j.cognition.2007.06.002. Epub 2007 Jul 12.
PubMed 17631876De Neys W, Vartanian O, Goel V. Smarter than we think: when our brains detect that we are biased. Psychol Sci. 2008 May;19(5):483-9. doi: 10.1111/j.1467-9280.2008.02113.x.
PubMed 18466410Frackowiak RSJ, Friston KJ, Frith C, Dolan R, Price CJ, Zeki S, Ashburner J, Penny WD. (2003). Human Brain Function. Academic Press, 2nd edition
Frank S, Kullmann S, Veit R. Food related processes in the insular cortex. Front Hum Neurosci. 2013 Aug 23;7:499. doi: 10.3389/fnhum.2013.00499. eCollection 2013.
PubMed 23986683Friston KJ, Ashburner J, Kiebel SJ, Nichols TE, Penny WD. (2007). Statistical Parametric Mapping: The Analysis of Functional Brain Images. Academic Press
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Networks of Decision Making Processes Triggered by Food Labels
- ClinicalTrials.gov ID
- NCT02841410
- Acronym / sponsor ID
- NeuroFood / 38RC14.322
- Conditions
- Healthy Volunteer
- Keywords
- Food, Emotion, Health, Nutrition, Heuristic, Reasoning, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 22 Jul 2016 (estimated)
- 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.
This fMRI study evaluated the cognitive mechanisms and the cerebral substrate of decision making when evaluating the healthiness of food products with nutritional information displayed either with a Traffic Light system, a colored nutritional label, and a Guideline Daily Amount system, a numeric label.
Detailed description
The investigators postulated that Traffic Light label would recruit emotion processes and activation of subjacent cerebral networks.
On the contrary, the nutritional information presented in a Guideline Daily Amount label, would recruit, due to its numeric format and higher complexity, supplementary cognitive processes and activation of related brain regions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | Other | Other: Magnetic Resonance Imaging |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- signed informed consent
- medical exam completed before participation in reserach
- to be insured under the social security system
- to be an adult between 18 and 50 years
Key exclusion criteria (3 listed)
- counter-argument to magnetic field exposure
- neurological or psychiatric disorder including eating disorders
- had
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 |
|---|---|---|
| Magnetic Resonance Imaging | Other | Healthy Volunteer |
Primary outcome
Evaluation of cerebral areas's activation
Time frame: About two hours
MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
- Background: PubMed 14573543Arana FS, Parkinson JA, Hinton E, Holland AJ, Owen AM, Roberts AC. Dissociable contributions of the human amygdala and orbitofrontal cortex to incentive motivation and goal selection. J Neurosci. 2003 Oct 22;23(29):9632-8. doi: 10.1523/JNEUROSCI.23-29-09632.2003.
- Background: PubMed 23891558Aschemann-Witzel J, Grunert KG, van Trijp HC, Bialkova S, Raats MM, Hodgkins C, Wasowicz-Kirylo G, Koenigstorfer J. Effects of nutrition label format and product assortment on the healthfulness of food choice. Appetite. 2013 Dec;71:63-74. doi: 10.1016/j.appet.2013.07.004. Epub 2013 Jul 23.
- Background: PubMed 21118983Basten U, Biele G, Heekeren HR, Fiebach CJ. How the brain integrates costs and benefits during decision making. Proc Natl Acad Sci U S A. 2010 Dec 14;107(50):21767-72. doi: 10.1073/pnas.0908104107. Epub 2010 Nov 30.
- Background: PubMed 16687507Beaver JD, Lawrence AD, van Ditzhuijzen J, Davis MH, Woods A, Calder AJ. Individual differences in reward drive predict neural responses to images of food. J Neurosci. 2006 May 10;26(19):5160-6. doi: 10.1523/JNEUROSCI.0350-06.2006.
- Background: PubMed 10448516Birch LL. Development of food preferences. Annu Rev Nutr. 1999;19:41-62. doi: 10.1146/annurev.nutr.19.1.41.
- Background: PubMed 19523212Borgmeier I, Westenhoefer J. Impact of different food label formats on healthiness evaluation and food choice of consumers: a randomized-controlled study. BMC Public Health. 2009 Jun 12;9:184. doi: 10.1186/1471-2458-9-184.
- Background: PubMed 15245501Braeutigam S, Rose SP, Swithenby SJ, Ambler T. The distributed neuronal systems supporting choice-making in real-life situations: differences between men and women when choosing groceries detected using magnetoencephalography. Eur J Neurosci. 2004 Jul;20(1):293-302. doi: 10.1111/j.1460-9568.2004.03467.x.
- BackgroundBurton S, Andrews JC. (1996), Age, Product Nutrition, and Label Format Effects on Consumer Perceptions and Product Evaluations. Journal of Consumer Affairs, 30, 68-89.
- Background: PubMed 21241532Campos S, Doxey J, Hammond D. Nutrition labels on pre-packaged foods: a systematic review. Public Health Nutr. 2011 Aug;14(8):1496-506. doi: 10.1017/S1368980010003290. Epub 2011 Jan 18.
- Background: PubMed 8281424Carelli RM, King VC, Hampson RE, Deadwyler SA. Firing patterns of nucleus accumbens neurons during cocaine self-administration in rats. Brain Res. 1993 Oct 29;626(1-2):14-22. doi: 10.1016/0006-8993(93)90557-4.
- Background: PubMed 17631876De Neys W, Glumicic T. Conflict monitoring in dual process theories of thinking. Cognition. 2008 Mar;106(3):1248-99. doi: 10.1016/j.cognition.2007.06.002. Epub 2007 Jul 12.
- Background: PubMed 18466410De Neys W, Vartanian O, Goel V. Smarter than we think: when our brains detect that we are biased. Psychol Sci. 2008 May;19(5):483-9. doi: 10.1111/j.1467-9280.2008.02113.x.
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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.
Alexandre Krainik principal investigator
Grenoble Hospital University
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging in people with Healthy Volunteer, run by University Hospital, Grenoble.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of cerebral areas's activation (time frame: About two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02841410, which also lists 38 linked publications.
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 22 Jul 2016.