Effects of Negative Affect in Individuals With Binge Eating Episodes

NCT03393039 | Active Not Recruiting

• 1 other identifier: 16-2658
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

Brief Summary

Binge-eating is characterized by recurrent episodes of eating large amounts of - typically high calorie - foods, eating much more rapidly than normal and until feeling uncomfortably full, as well as feeling disgusted with oneself, depressed, or guilty after those episodes. Two eating disorders are characterized by binge-eating as central diagnostic criteria, binge-eating disorder (BED) and bulimia nervosa (BN). Binge-eating episodes in BN, but not BED, are typically followed by compensatory mechanisms such as self-induced vomiting, and BED is typically associated with obesity, while BN is not. Behavior studies such as ecological momentary assessment (EMA) research of affect in an individual's naturalistic environment have shown that negative affect and negative urgency (the tendency to act rashly when distressed) often precede binge-eating. The Investigators want to answer the following questions: Can negative affect in BN and BED be linked to 1) altered dopamine related brain reinforcement learning, 2) to food value computation and cognitive control circuit function, and 3) can dopamine related brain activation predict eating and negative affect, indicating a brain based neurobiological vulnerability. Answering those questions will help to define binge-eating based on regulation of brain reward, cognition, and emotion circuit function and point toward potential psychopharmacological interventions to normalize brain function and behavior.

Conditions

Bulimia Nervosa; Binge-Eating Disorder; Obesity; Eating Disorder

Keywords

fMRI; Reward; Food Choices; Negative Affect

Outcome Measures

Primary Outcomes (3)

• Taste Reward Brain Response to Negative Affect fMRI Task

  to study brain activation in a taste reward task in response to negative affect

  5 years

• Food Choice Brain Response to Negative Affect fMRI Task

  to study brain activation in a food choice task in response to negative affect

  5 years

• Brain Activation and Food Intake/negative Affect Relationships

  To test whether brain activation predicts food intake or negative affect

  5 years

Study Arms (1)

Behavioral

EXPERIMENTAL

Negative Affect Task

Behavioral: Negative Affect Task

Interventions

Negative Affect Task BEHAVIORAL

fMRI stress task

Also known as: Functional Magnetic Resonance Brain Imaging Stress Task

Behavioral

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Controls
• Age 18-55 years old
• Healthy body weight between 90 and 110 % average body weight since puberty.
• Regular monthly menstrual cycle (if applicable)
• Edinburgh Handedness Inventory Revised (EHI-R) LQ\* score \> +200
• Obese
• Age 18-55 years old
• Current body mass index (BMI) \> 30 kg/m2.
• Stable food intake regimen in previous 4 weeks.
• Edinburgh Handedness Inventory Revised (EHI-R) LQ\* score \> +200
• Obese for at least one year
• Binge Eating Disorder
• Age 18-55 years old
• Edinburgh Handedness Inventory Revised (EHI-R) LQ\* score \> +200
• DSM 5 diagnosis of Binge Eating Disorder A. Recurrent episodes of binge eating B. Binge eating episodes are associated with three (or more) of the following

You may not qualify if:

• Healthy Controls
• Current pregnancy or breast feeding within last 3 months
• First degree relative with current or past eating disorder
• Current Medications other than BCP or IUD
• Past or present Axis I psychiatric disorder including substance or alcohol use disorder as determined through SCID-5 clinical interview
• First degree relative with an eating disorder
• Major Medical illness
• Recent history of suspected substance abuse or a lifetime history of psychostimulant abuse and/or dependence
• Metal implants or braces
• Obese
• Current pregnancy or breast feeding within last 3 months
• First degree relative with current or past eating disorder
• Current or previous eating disorder diagnosis
• Current Medications other than BCP or IUD
• Past or present Axis I psychiatric disorder including substance or alcohol use disorder as determined through SCID-5 clinical interview

Sponsors & Collaborators

• University of California, San Diego: lead
• Sanford Research: collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

University of California at San Diego

San Diego, California, 92121, United States

Location

Related Publications (5)

• Engel SG, Kahler KA, Lystad CM, Crosby RD, Simonich HK, Wonderlich SA, Peterson CB, Mitchell JE. Eating behavior in obese BED, obese non-BED, and non-obese control participants: a naturalistic study. Behav Res Ther. 2009 Oct;47(10):897-900. doi: 10.1016/j.brat.2009.06.018. Epub 2009 Jul 7.

  PMID: 19631931 BACKGROUND

• Berg KC, Crosby RD, Cao L, Crow SJ, Engel SG, Wonderlich SA, Peterson CB. Negative affect prior to and following overeating-only, loss of control eating-only, and binge eating episodes in obese adults. Int J Eat Disord. 2015 Sep;48(6):641-53. doi: 10.1002/eat.22401. Epub 2015 Mar 23.

  PMID: 25808854 BACKGROUND

• Pearson CM, Wonderlich SA, Smith GT. A risk and maintenance model for bulimia nervosa: From impulsive action to compulsive behavior. Psychol Rev. 2015 Jul;122(3):516-35. doi: 10.1037/a0039268. Epub 2015 May 11.

  PMID: 25961467 BACKGROUND

• Racine SE, Burt SA, Keel PK, Sisk CL, Neale MC, Boker S, Klump KL. Examining associations between negative urgency and key components of objective binge episodes. Int J Eat Disord. 2015 Jul;48(5):527-31. doi: 10.1002/eat.22412. Epub 2015 Apr 10.

  PMID: 25865091 BACKGROUND

• Engel SG, Crosby RD, Thomas G, Bond D, Lavender JM, Mason T, Steffen KJ, Green DD, Wonderlich SA. Ecological Momentary Assessment in Eating Disorder and Obesity Research: a Review of the Recent Literature. Curr Psychiatry Rep. 2016 Apr;18(4):37. doi: 10.1007/s11920-016-0672-7.

  PMID: 26893235 BACKGROUND

MeSH Terms

Conditions

Bulimia Nervosa; Binge-Eating Disorder; Obesity; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Guido KW Frank, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 8, 2018
• Study Start: February 1, 2018
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (1)