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Hed-O-Shift: Hedonic and Neurocognitive Processes in Relation to Dietary Habits and Weight Status (Hed-O-Shift)

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ClinicalTrials.gov Identifier: NCT03076489
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Institut National de la Recherche Agronomique
Information provided by (Responsible Party):
Rennes University Hospital

Brief 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 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.


Condition or disease Intervention/treatment Phase
Neurocognitive Correlates of Eating Habits Other: First Visit Other: on-line questionnaires Device: fMRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Hed-O-Shift: Hedonic and Neurocognitive Processes in Relation to Dietary Habits and Weight Status
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : April 16, 2019
Actual Study Completion Date : April 16, 2019

Arm Intervention/treatment
Experimental: high consumption habits
high consumption habits of fatty and sugary foods
Other: First Visit
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

Other: on-line questionnaires
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.

Device: fMRI
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.

Experimental: low consumption habits
low consumption habits of fatty and sugary foods
Other: First Visit
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

Other: on-line questionnaires
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.

Device: fMRI
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  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. [ Time Frame: at 2 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 ");
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076489


Locations
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France
Centre Hospitalier Universitaire Rennes Pontchaillou
Rennes, France, 35000
Sponsors and Collaborators
Rennes University Hospital
Institut National de la Recherche Agronomique

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03076489     History of Changes
Other Study ID Numbers: 35RC17_9740_Hed-O-Shift
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No