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

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 Overview

• Status: Completed
• Conditions: Neurocognitive Correlates of Eating Habits
• Intervention / Treatment: Other: First Visit; Other: on-line questionnaires; Device: fMRI

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • Centre Hospitalier Universitaire Rennes Pontchaillou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	at 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 2 weeks

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Publications and helpful links

General 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.
• Coquery 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): April 16, 2019
• Study Completion (Actual): April 16, 2019

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 35RC17_9740_Hed-O-Shift

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No