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Hedonic Perception and Brain Activity Response to Meal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02592239
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Tracking Information
First Submitted Date  ICMJE March 17, 2015
First Posted Date  ICMJE October 30, 2015
Last Update Posted Date July 27, 2017
Study Start Date  ICMJE November 2014
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
  • Change in activity in specific brain regions measured by functional MRI [ Time Frame: 3 hours ]
    To determine the brain response to a meal in patients with functional dyspepsia and healthy subjects.
  • Cognitive and hedonic perception measured on 10 score scales (composite outcome) [ Time Frame: 3 hours ]
    To determine the cognitive and hedonic response to a meal in patients with functional dyspepsia and healthy subjects.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02592239 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
Metabolomic response measured in serum by NMR spectroscopy [ Time Frame: 3 hours ]
To identify the metabolomic substrate of the cognitive and brain responses to a meal.
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 Hedonic Perception and Brain Activity Response to Meal
Official Title  ICMJE Hedonic Perception and Brain Activity Response to Meal in Health and Functional Dyspepsia
Brief Summary The purpose of this study is to determine the relationship between brain activity and the perception of subjective hedonic sensations in response to a meal using functional MRI.
Detailed Description Functional MRI brain imaging will be performed in patients with functional dyspepsia and healthy controls in basal conditions and after a palatable test meal. During the study, the cognitive response and the hedonic dimension will be measured using 10 score scales.
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: Diagnostic
Condition  ICMJE Dyspepsia
Intervention  ICMJE
  • Device: Functional brain MRI
    Functional brain MRI before and after test meal ingestion
  • Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice
Study Arms  ICMJE
  • Experimental: Patients
    Functional dyspepsia patients will be studied using functional brain MRI before and after receiving a test meal. Cognitive and hedonic response will be evaluated using 10 score scales.
    Interventions:
    • Device: Functional brain MRI
    • Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice
  • Experimental: Controls
    Healthy subjects recruited by public advertisement will be studied using functional brain MRI before and after receiving a test meal. Cognitive and hedonic response will be evaluated using 10 score scales.
    Interventions:
    • Device: Functional brain MRI
    • Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice
Publications *

*   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: October 29, 2015)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age between 18 and 80 yrs
  2. Body mass index between 18-30 Kg/m2
  3. Right-handed

Exclusion Criteria:

  1. Subjects with clinical history of eating-disorders
  2. Subjects with clinical history of significant head-trauma
  3. Subjects with known serious illness: clinically significant cardiac, vascular, liver, pulmonary, or psychiatric disorders (as evaluated by the Investigator).
  4. Subjects with a known history of alcohol or drug abuse in the previous 6 months.
  5. Subjects using medications with SNS effects that cannot be discontinued, such as: antidepressants, pregabalin, gabapentin.
  6. Women that are pregnant or that are breast-feeding.
  7. Claustrophobia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02592239
Other Study ID Numbers  ICMJE PR(AG)214/2012 Addendum
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital Universitari Vall d'Hebron Research Institute
Study Sponsor  ICMJE Hospital Universitari Vall d'Hebron Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital Universitari Vall d'Hebron Research Institute
Verification Date September 2016

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