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
About this trial
This is an interventional basic science trial for Obesity focused on measuring Obesity, Binge eating disorder, fMRI, gut hormones
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
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
NCT ID
NCT02038712
First Posted
January 10, 2014
Last Updated
January 14, 2014
Sponsor
New York Obesity and Nutrition Research Center
Collaborators
Columbia University
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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