NCT03076489

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2019

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

March 7, 2017

Last Update Submit

May 22, 2023

Conditions

Neurocognitive Correlates of Eating Habits

Outcome Measures

Primary Outcomes (1)

  • 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 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.

    at 2 weeks

Study Arms (2)

high consumption habits

EXPERIMENTAL

high consumption habits of fatty and sugary foods

Other: First VisitOther: on-line questionnairesDevice: fMRI

low consumption habits

EXPERIMENTAL

low consumption habits of fatty and sugary foods

Other: First VisitOther: on-line questionnairesDevice: fMRI

Interventions

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

high consumption habitslow consumption habits
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.

high consumption habitslow consumption habits
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.

high consumption habitslow consumption habits

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Rennes Pontchaillou

Rennes, 35000, France

Location

Related Publications (2)

  • 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.

    PMID: 30009932RESULT

  • 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.

    PMID: 35811938RESULT

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 10, 2017

Study Start

June 15, 2017

Primary Completion

April 16, 2019

Study Completion

April 16, 2019

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations

FR(1)