fMRI and Ghlrein in Obesity and Binge Eating Disorder

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Binge Eating Disorder
• Intervention / Treatment: Dietary supplement: Fed Condition; Dietary supplement: Fasted condition; Procedure: Blood samples; Behavioral: Subjective appetite ratings; Procedure: fMRI scan

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Binge eating disorder (BED); 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.	Dietary supplement: Fed Condition; Subjects will consume a 600mL 600kcal liquid test meal; Other Names: Boost (Novartis Nutrition); Dietary supplement: Fasted condition; Subjects will consume 600mL plain water.; Procedure: Blood samples; Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min; Behavioral: Subjective appetite ratings; Appetite ratings will be collected at -15, 0, 10, 30, 60, 90, 120 min.; Procedure: fMRI scan; 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).
Experimental: Control; 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.	Dietary supplement: Fed Condition; Subjects will consume a 600mL 600kcal liquid test meal; Other Names: Boost (Novartis Nutrition); Dietary supplement: Fasted condition; Subjects will consume 600mL plain water.; Procedure: Blood samples; Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min; Behavioral: Subjective appetite ratings; Appetite ratings will be collected at -15, 0, 10, 30, 60, 90, 120 min.; Procedure: fMRI scan; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	45 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	120 min
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	120 min

Collaborators and Investigators

• Sponsor: New York Obesity and Nutrition Research Center
• Collaborators: Columbia University
• Investigators: Principal Investigator: Allan Geliebter, PhD, New York Obesity Nutrition Research Center

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimate): January 16, 2014

Study Record Updates

• Last Update Posted (Estimate): January 16, 2014
• Last Update Submitted That Met QC Criteria: January 14, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Obesity; fMRI; Binge eating disorder; gut hormones
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Signs and Symptoms, Digestive; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperphagia; Obesity; Disease; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
• Other Study ID Numbers: 06-164