fMRI and Ghlrein in Obesity and Binge Eating Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2013-09-30

Brief Summary

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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.

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RECRUITING

Detailed Description

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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.

Conditions

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Obesity Binge Eating Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fed Condition

Intervention Type DIETARY_SUPPLEMENT

Subjects will consume a 600mL 600kcal liquid test meal

Fasted condition

Intervention Type DIETARY_SUPPLEMENT

Subjects will consume 600mL plain water.

Blood samples

Intervention Type PROCEDURE

Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min

Subjective appetite ratings

Intervention Type BEHAVIORAL

Appetite ratings will be collected at -15, 0, 10, 30, 60, 90, 120 min.

fMRI scan

Intervention Type PROCEDURE

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).

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.

Group Type EXPERIMENTAL

Fed Condition

Intervention Type DIETARY_SUPPLEMENT

Subjects will consume a 600mL 600kcal liquid test meal

Fasted condition

Intervention Type DIETARY_SUPPLEMENT

Subjects will consume 600mL plain water.

Blood samples

Intervention Type PROCEDURE

Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min

Subjective appetite ratings

Intervention Type BEHAVIORAL

Appetite ratings will be collected at -15, 0, 10, 30, 60, 90, 120 min.

fMRI scan

Intervention Type PROCEDURE

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).

Interventions

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Fed Condition

Subjects will consume a 600mL 600kcal liquid test meal

Intervention Type DIETARY_SUPPLEMENT

Fasted condition

Subjects will consume 600mL plain water.

Intervention Type DIETARY_SUPPLEMENT

Blood samples

Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min

Intervention Type PROCEDURE

Subjective appetite ratings

Appetite ratings will be collected at -15, 0, 10, 30, 60, 90, 120 min.

Intervention Type BEHAVIORAL

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).

Intervention Type PROCEDURE

Other Intervention Names

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Boost (Novartis Nutrition)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes