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OpenTrials
Completed

NCT Number: NCT02038712

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.

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Key information

Conditions

Obesity Binge Eating Disorder Binge-Eating Disorder Body Weight Feeding and Eating Disorders Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fed condition

Dietary Supplement

Subjects will consume a 600mL 600kcal liquid test meal

Other names: Boost (Novartis Nutrition)

Fasted condition

Dietary Supplement

Subjects will consume 600mL plain water.

Blood samples

Procedure

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

Subjective appetite ratings

Behavioral

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

fMRI scan

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).

Primary outcomes

  1. fMRI responses to food cues

    Time frame: 45 min

    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 outcomes

  1. Gut hormone responses

    Time frame: 120 min

    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.

  2. Subjective appetite ratings

    Time frame: 120 min

    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

Sponsors and collaborators

Lead sponsor

New York Obesity and Nutrition Research Center

Other

Collaborators

  • Columbia University

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2013
First posted
Jan 16, 2014
Registry last updated
Jan 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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