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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

Tracking Information
First Submitted Date  ICMJE March 7, 2017
First Posted Date  ICMJE March 10, 2017
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE June 15, 2017
Actual Primary Completion Date April 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03076489 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hed-O-Shift: Hedonic and Neurocognitive Processes in Relation to Dietary Habits and Weight Status
Official Title  ICMJE Hed-O-Shift: Hedonic and Neurocognitive Processes in Relation to Dietary Habits and Weight Status
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Neurocognitive Correlates of Eating Habits
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: high consumption habits
    high consumption habits of fatty and sugary foods
    Interventions:
    • Other: First Visit
    • Other: on-line questionnaires
    • Device: fMRI
  • Experimental: low consumption habits
    low consumption habits of fatty and sugary foods
    Interventions:
    • Other: First Visit
    • Other: on-line questionnaires
    • Device: fMRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2019)
50
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2017)
40
Actual Study Completion Date  ICMJE April 16, 2019
Actual Primary Completion Date April 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 24 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03076489
Other Study ID Numbers  ICMJE 35RC17_9740_Hed-O-Shift
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rennes University Hospital
Study Sponsor  ICMJE Rennes University Hospital
Collaborators  ICMJE Institut National de la Recherche Agronomique
Investigators  ICMJE Not Provided
PRS Account Rennes University Hospital
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP