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fMRI and Ghlrein in Obesity and Binge Eating Disorder

Primary Purpose

Obesity, Binge Eating Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fed Condition
Fasted condition
Blood samples
Subjective appetite ratings
fMRI scan
Sponsored by
New York Obesity and Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, Binge eating disorder, fMRI, gut hormones

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-65 years
  • BMI 30-50 kg/m2
  • Weight stable (<5% change in body weight during past 3 months)
  • Right handed

Exclusion Criteria:

  • Smokers
  • Regular use of medications
  • Current or intended participation in a weight-loss program (diet or exercise)
  • Females who are pregnant or lactating

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Binge eating disorder (BED)

    Control

    Arm Description

    Blood samples, subjective appetite ratings and fMRI scan will be collected in subjects who meet the current criteria for binge eating disorder (BED) in the fed condition and fasted condition.

    Blood samples, subjective appetite ratings and fMRI scan will be collected in subjects who do not meet the current criteria for BED (Controls) in the fed condition and fasted condition.

    Outcomes

    Primary Outcome Measures

    fMRI responses to food cues
    Blood oxygen dependent signal (BOLD) response in exposure to auditory and visual food cues will be measured during a fMRI scan and the difference between responses in the fed condition compared with those in the fasted condition.

    Secondary Outcome Measures

    Gut hormone responses
    Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min following the ingestion of the liquid test meal and analyzed to determine the gut hormone responses.
    Subjective appetite ratings
    Subjective ratings of appetite will be collected using a visual analogue scale (VAS) at -15, 0, 10, 30, 60, 90, 120 min following the liquid test meal

    Full Information

    First Posted
    January 10, 2014
    Last Updated
    January 14, 2014
    Sponsor
    New York Obesity and Nutrition Research Center
    Collaborators
    Columbia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02038712
    Brief Title
    fMRI and Ghlrein in Obesity and Binge Eating Disorder
    Official Title
    fMRI and Ghlrein in Obesity and Binge Eating Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2006 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    New York Obesity and Nutrition Research Center
    Collaborators
    Columbia University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Binge Eating Disorder (BED) may be associated with he development of obesity. However, the pathogenesis of BED is currently unclear, thus making the development of treatment and prevention strategies for BED difficult. Differences in the mechanisms regulating food intake may go some way to reveal potential mechanisms for BED.The purpose of this study is to investigate the responses of key gut-derived hormones that are associated with the regulation of food intake and functional brain activity to food cues using fMRI in BED patients and weight matched controls.
    Detailed Description
    Participants will attend the laboratory on two separate occasions following an overnight fast. Following baseline measures they will be provided wither with a 600mL (600kcal) liquid meal (Fed condition) or a volume matched amount of plain water (Fasted condition) to consume within 15 min in a randomized crossover design. Blood samples will be collected for during the subsequent 120min to measure the glucose, insulin and gut hormone responses, and subjective appetite ratings will be collected. 1500mg of acetaminophen will be added to each of the test drinks so that the appearance in the blood can be used as a proxy measure of gastric emptying. Participants will then undergo a 45min brain scan to assess the responses to visual and auditory food cues.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Binge Eating Disorder
    Keywords
    Obesity, Binge eating disorder, fMRI, gut hormones

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    93 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Binge eating disorder (BED)
    Arm Type
    Experimental
    Arm Description
    Blood samples, subjective appetite ratings and fMRI scan will be collected in subjects who meet the current criteria for binge eating disorder (BED) in the fed condition and fasted condition.
    Arm Title
    Control
    Arm Type
    Experimental
    Arm Description
    Blood samples, subjective appetite ratings and fMRI scan will be collected in subjects who do not meet the current criteria for BED (Controls) in the fed condition and fasted condition.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Fed Condition
    Other Intervention Name(s)
    Boost (Novartis Nutrition)
    Intervention Description
    Subjects will consume a 600mL 600kcal liquid test meal
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Fasted condition
    Intervention Description
    Subjects will consume 600mL plain water.
    Intervention Type
    Procedure
    Intervention Name(s)
    Blood samples
    Intervention Description
    Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min
    Intervention Type
    Behavioral
    Intervention Name(s)
    Subjective appetite ratings
    Intervention Description
    Appetite ratings will be collected at -15, 0, 10, 30, 60, 90, 120 min.
    Intervention Type
    Procedure
    Intervention Name(s)
    fMRI scan
    Intervention Description
    Blood Oxygen Dependent (BOLD) signal response to pictures and words of food and non-food items will be measured using functional magnetic resonance imaging (fMRI).
    Primary Outcome Measure Information:
    Title
    fMRI responses to food cues
    Description
    Blood oxygen dependent signal (BOLD) response in exposure to auditory and visual food cues will be measured during a fMRI scan and the difference between responses in the fed condition compared with those in the fasted condition.
    Time Frame
    45 min
    Secondary Outcome Measure Information:
    Title
    Gut hormone responses
    Description
    Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min following the ingestion of the liquid test meal and analyzed to determine the gut hormone responses.
    Time Frame
    120 min
    Title
    Subjective appetite ratings
    Description
    Subjective ratings of appetite will be collected using a visual analogue scale (VAS) at -15, 0, 10, 30, 60, 90, 120 min following the liquid test meal
    Time Frame
    120 min

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 18-65 years BMI 30-50 kg/m2 Weight stable (<5% change in body weight during past 3 months) Right handed Exclusion Criteria: Smokers Regular use of medications Current or intended participation in a weight-loss program (diet or exercise) Females who are pregnant or lactating
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Allan Geliebter, PhD
    Organizational Affiliation
    New York Obesity Nutrition Research Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    fMRI and Ghlrein in Obesity and Binge Eating Disorder

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