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Completed

NCT Number: NCT03076489

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

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.

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Key information

Conditions

Neurocognitive Correlates of Eating Habits

Age range

18 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Rennes Pontchaillou

Rennes, 35000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

First Visit

Other

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 questionnaires

Other

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.

fMRI

Device

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 outcomes

  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 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.

    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.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Registry information

Acronym: Hed-O-Shift

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2017
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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