Neurocognitive Correlates of Eating HabitsHed-O-ShiftNCT03076489
Hed-O-Shift: Hedonic and Neurocognitive Processes in Relation to Dietary Habits and Weight Status
A study testing First Visit, on-line questionnaires and fMRI in people with Neurocognitive Correlates of Eating Habits, run by Rennes University Hospital at 1 site in France.
Trial summary
This study includes an inclusion visit, 2 visits to the Rennes University Hospital and the filling of two on-line questionnaires. The first visit to the University-Hospital of Rennes, during which a blood sample will be taken, morpho-anatomic measures (height, weight, hip and size), impedancemetry and resting energy… Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Correlates of Eating Habits
- What is being tested?
- First Visit, on-line questionnaires and fMRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2017to 16 Apr 2019
- 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 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-24,
- Presenting a normal BMI (18-25),
- Right-handers,
- Affiliated to a social security scheme
- Having given a free, informed and written consent.
- Having a low frequency of consumption of fatty and / or sugary / salty foods, or on the contrary, a high frequency of consumption of these foods.
Who cannot join
- Related to the study:
- High level athletes, (determined on the basis of the Ricci \& Gagnon questionnaire - excluded if score > 32);
- Food abstinents for religious, ideological or health reasons (intolerance, vegetarianism, allergies, etc.);
- Family history of obesity or diabetes;
- Personal history of TCA, anxiety or depressive disorder, or proven addictive behaviour;
- Excessive consumption of alcohol or other psychoactive substances (determined on the basis of the AUDIT questionnaires - excluded if score > 7 and CRAFT - excluded if score> 2 " yes ");
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- Smoking daily or having stopped for less than 6 months;
- History of bariatric surgery;
- On-going treatment in the nutrition unit;
- Insufficient command of French;
- Pregnant or nursing women;
- Persons of full age who are subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
- Simultaneous participation in another research protocol involving the human person
- Related to fMRI:
- Implantable cardiac pacemaker or defibrillator;
- Neurosurgical clips;
- Cochlear implants;
- Neural or peripheral stimulator;
- Foreign orbital or brain metallic foreign bodies;
- Endoprostheses implanted for less than 4 weeks and osteosynthesis materials placed for less than 6 weeks;
- Claustrophobia.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire Rennes Pontchaillou
Rennes, 35000
About this study
This study includes an inclusion visit, 2 visits to the Rennes University Hospital and the filling of two on-line questionnaires.
The first visit to the University-Hospital of Rennes, during which a blood sample will be taken, morpho-anatomic measures (height, weight, hip and size), impedancemetry and resting energy expenditure by indirect calorimetry will be carried out in the Clinical Investigation Unit.
Read more
During this visit, the volunteers will also have to bring a sample of urine and faeces previously collected at home.
The two on-line questionnaires (hedonic and caloric evaluation of foods and beverages on photos) will have to be completed by the volunteers between the first and the second visit to the University-Hospital.
Finally, the volunteers will go to the University-Hospital of Rennes for the second visit, on the Neurinfo platform, during which they will be subjected to a cognitive two-choice test based on food and drink pictures, during fMRI. Before and after the fMRI session, an assessment of the state of hunger, thirst, and general status of the volunteer will be carried out using a numerical scale ranging from 1 to 10.
- Being tested
- First Visit, on-line questionnaires, fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First VisitOther
blood sample , morpho-anatomic measures (height, weight, hip and size), impedancemetry and resting energy expenditure by indirect calorimetry, sample of urine and faeces previously collected at home
on-line questionnairesOther
The two on-line questionnaires (hedonic and caloric evaluation of foods and beverages on photos) will have to be completed by the volunteers between the first and the second visit to the University-Hospital.
fMRIDevice
a cognitive two-choice test based on food and drink pictures, during fMRI. Before and after the fMRI session, an assessment of the state of hunger, thirst, and general status of the volunteer will be carried out using a numerical scale ranging from 1 to 10.
| Study group | Role | What they receive |
|---|---|---|
| high consumption habits | Experimental | high consumption habits of fatty and sugary foods Receives: Other: First Visit; Other: on-line questionnaires; Device: fMRI |
| low consumption habits | Experimental | low consumption habits of fatty and sugary foods Receives: Other: First Visit; Other: on-line questionnaires; Device: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant change in cerebral activity in zones involved in food intake inhibition control
Significant change in cerebral activity (expressed as a significant variation in hemodynamic response BOLD in the condition of food cognitive tasks) in zones involved in food intake inhibition control (dorso-lateral prefrontal cortex, upper frontal gyrus)
Measured: at 2 weeks
Secondary outcomes (1)
Significant change in cerebral activity in areas involved in the control of reward and motivation (striatum dorsal, insula), associated with modulation of the intestinal microbiota and metabolic and hormonal homeostasis.
Significant change in cerebral activity in areas involved in the control of reward and motivation (striatum dorsal, insula), associated with modulation of the intestinal microbiota and metabolic and hormonal homeostasis.
Measured: at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start15 Jun 2017
- Primary completion16 Apr 2019
- Study completion16 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurocognitive Correlates of Eating HabitsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076489
- Sponsor's protocol ID
- 35RC17_9740_Hed-O-Shift
- Acronym
- Hed-O-Shift
- Status last verified
- May 2023
- First submitted
- 7 Mar 2017
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Constant A, Gautier Y, Coquery N, Thibault R, Moirand R, Val-Laillet D. Emotional overeating is common and negatively associated with alcohol use in normal-weight female university students. Appetite. 2018 Oct 1;129:186-191. doi: 10.1016/j.appet.2018.07.012. Epub 2018 Jul 17.
PubMed 30009932Coquery N, Gautier Y, Serrand Y, Meurice P, Bannier E, Thibault R, Constant A, Moirand R, Val-Laillet D. Brain Responses to Food Choices and Decisions Depend on Individual Hedonic Profiles and Eating Habits in Healthy Young Women. Front Nutr. 2022 Jun 24;9:920170. doi: 10.3389/fnut.2022.920170. eCollection 2022.
PubMed 35811938
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hed-O-Shift: Hedonic and Neurocognitive Processes in Relation to Dietary Habits and Weight Status
- ClinicalTrials.gov ID
- NCT03076489
- Acronym / sponsor ID
- Hed-O-Shift / 35RC17_9740_Hed-O-Shift
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 10 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.
This study includes an inclusion visit, 2 visits to the Rennes University Hospital and the filling of two on-line questionnaires.
The first visit to the University-Hospital of Rennes, during which a blood sample will be taken, morpho-anatomic measures (height, weight, hip and size), impedancemetry and resting energy expenditure by indirect calorimetry will be carried out in the Clinical Investigation Unit.
During this visit, the volunteers will also have to bring a sample of urine and faeces previously collected at home.
The two on-line questionnaires (hedonic and caloric evaluation of foods and beverages on photos) will have to be completed by the volunteers between the first and the second visit to the University-Hospital.
Finally, the volunteers will go to the University-Hospital of Rennes for the second visit, on the Neurinfo platform, during which they will be subjected to a cognitive two-choice test based on food and drink pictures, during fMRI. Before and after the fMRI session, an assessment of the state of hunger, thirst, and general status of the volunteer will be carried out using a numerical scale ranging from 1 to 10.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high consumption habits | Experimental | Other: First Visit, Other: on-line questionnaires, Device: fMRIhigh consumption habits of fatty and sugary foods |
| low consumption habits | Experimental | Other: First Visit, Other: on-line questionnaires, Device: fMRIlow consumption habits of fatty and sugary foods |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18-24,
- Presenting a normal BMI (18-25),
- Right-handers,
- Affiliated to a social security scheme
- Having given a free, informed and written consent.
Key exclusion criteria (21 listed)
- Related to the study:
- High level athletes, (determined on the basis of the Ricci \& Gagnon questionnaire - excluded if score > 32);
- Food abstinents for religious, ideological or health reasons (intolerance, vegetarianism, allergies, etc.);
- Family history of obesity or diabetes;
- Personal history of TCA, anxiety or depressive disorder, or proven addictive behaviour;
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 |
|---|---|---|
| First Visitblood sample , morpho-anatomic measures (height, weight, hip and size), impedancemetry and resting energy expenditure by indirect calorimetry, sample of urine and faeces previously collected at home | Other | high consumption habits, low consumption habits |
| on-line questionnairesThe two on-line questionnaires (hedonic and caloric evaluation of foods and beverages on photos) will have to be completed by the volunteers between the first and the second visit to the University-Hospital. | Other | high consumption habits, low consumption habits |
| fMRIa cognitive two-choice test based on food and drink pictures, during fMRI. Before and after the fMRI session, an assessment of the state of hunger, thirst, and general status of the volunteer will be carried out using a numerical scale ranging from 1 to 10. | Device | high consumption habits, low consumption habits |
Primary outcome
Significant change in cerebral activity in zones involved in food intake inhibition control
Time frame: at 2 weeks
Significant change in cerebral activity (expressed as a significant variation in hemodynamic response BOLD in the condition of food cognitive tasks) in zones involved in food intake inhibition control (dorso-lateral prefrontal cortex, upper frontal gyrus)
1 secondary outcome
Significant change in cerebral activity in areas involved in the control of reward and motivation (striatum dorsal, insula), associated with modulation of the intestinal microbiota and metabolic and hormonal homeostasis.
Time frame: at 2 weeks
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 23 May 2023.
- Results publication: PubMed 30009932Constant A, Gautier Y, Coquery N, Thibault R, Moirand R, Val-Laillet D. Emotional overeating is common and negatively associated with alcohol use in normal-weight female university students. Appetite. 2018 Oct 1;129:186-191. doi: 10.1016/j.appet.2018.07.012. Epub 2018 Jul 17.
- Results publication: PubMed 35811938Coquery N, Gautier Y, Serrand Y, Meurice P, Bannier E, Thibault R, Constant A, Moirand R, Val-Laillet D. Brain Responses to Food Choices and Decisions Depend on Individual Hedonic Profiles and Eating Habits in Healthy Young Women. Front Nutr. 2022 Jun 24;9:920170. doi: 10.3389/fnut.2022.920170. eCollection 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First Visit, on-line questionnaires and fMRI in people with Neurocognitive Correlates of Eating Habits, run by Rennes University Hospital 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 6 inclusion and 21 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 23 May 2023. 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 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?
Significant change in cerebral activity in zones involved in food intake inhibition control (time frame: at 2 weeks). 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 NCT03076489, which also lists 2 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 23 May 2023.