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Effects of Negative Affect in Individuals With Binge Eating Episodes

Primary Purpose

Bulimia Nervosa, Binge-Eating Disorder, Obesity

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Negative Affect Task

About this trial

This is an interventional basic science trial for Bulimia Nervosa focused on measuring fMRI, Reward, Food Choices, Negative Affect

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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
1. Eating much more rapidly than normal.
2. Eating until feeling uncomfortably full.
3. Eating large amounts of food when not feeling physically hungry.
4. Eating alone because of embarrassment.
5. Feeling disgusted with oneself, depressed, or very guilty after overeating. C. Marked distress regarding binge eating is present. D. At least once a week for 3 months. E. The binge eating is not associated with the recurrent use of inappropriate compensatory behavior.

Bulimia Nervosa

Age 18-55 years old
Edinburgh Handedness Inventory Revised (EHI-R) LQ* score > +200
DSM 5 diagnosis of Bulimia Nervosa A. Recurrent episodes of binge eating Eating, in a discrete period of time, an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances.

A sense of lack of control over eating during the episode. B. Recurrent inappropriate compensatory behavior in order to prevent weight gain, such as self-induced vomiting; misuse of laxatives, diuretics, or other medications; fasting; or excessive exercise.

C. At least once a week for 3 months. D. Self-evaluation is unduly influenced by body shape and weight.

Exclusion Criteria:

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
Major Medical illness
Recent history of suspected substance abuse or a lifetime history of psychostimulant abuse and/or dependence
Metal implants or braces

Binge Eating Disorder

Pregnancy or breast feeding within last 3 months
Lifetime history of bipolar disorder or psychosis
Use of a psychostimulant within the prior 6 months
Recent history of substance abuse or dependence (except for alcohol and cannabis use)
Major Medical illness
Metal implants or braces

Bulimia Nervosa

Pregnancy or breast feeding within last 3 months
Lifetime history of bipolar disorder or psychosis
Use of a psychostimulant within the prior 6 months
Recent history of substance abuse or dependence (except for alcohol and cannabis use)
Major Medical illness
Metal implants or braces

Sites / Locations

University of California at San DiegoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Behavioral

Arm Description

Negative Affect Task

Outcomes

Primary Outcome Measures

Taste Reward Brain Response to Negative Affect fMRI Task

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

Food Choice Brain Response to Negative Affect fMRI Task

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

Brain Activation and Food Intake/negative Affect Relationships

To test whether brain activation predicts food intake or negative affect

Secondary Outcome Measures

Full Information

NCT ID

NCT03393039

First Posted

December 28, 2017

Last Updated

October 10, 2023

Sponsor

University of California, San Diego

Collaborators

Sanford Research, University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT03393039

Brief Title

Effects of Negative Affect in Individuals With Binge Eating Episodes

Official Title

Neural Effects of Negative Affect on Food Choices and Reward In Individuals With Binge Eating Episodes

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2018 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

Sanford Research, University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Specific Aim 1: To test on two study days, one neutral affect and one negative affect day (affect induction) whether negative affect alters brain reinforcement learning in a dopamine system anchored taste reward learning paradigm (a task for prediction error and reward value computation) during functional magnetic resonance brain imaging (fMRI). Hypothesis 1: In response to negative and compared to neutral affect induction, binge eating disorder (BED) and bulimia nervosa (BN) will show increased positive prediction error and taste valuation regression with striatum and insula activation compared to obese (OB) and healthy control (HC) groups. This will be an indication that negative affect excessively activates dopamine related reward circuit response in BED and BN. Specific Aim 2: To study during a food choice paradigm the effects of negative affect on brain circuitry for cognitive control and food valuation. Specific Aim 2a: To study brain circuitry for food valuation in response to neutral or negative affect. Hypothesis 2a: In response to negative and compared to neutral affect induction, BED and BN groups will show greater striatal activation when rating food for taste, compared to OB and HC. This will indicate that BED and BN are associated with increased affect-regulated motivation to approach high calorie foods after negative affect induction and compared to OB and HC. Specific Aim 2b: To study brain control circuitry during food choice in response to neutral or negative affect. Hypothesis 2b: In response to negative and compared to neutral affect induction, BED and BN groups will show increased insula and striatal, but lower dorsolateral prefrontal cortex (DLPFC) activation compared to OB and HC groups. This will indicate that negative affect activates automatic food reward circuit response, but reduces cognitive control circuitry during food choice in BED and BN. Specific Aim 3: To test whether brain activation predicts food intake or negative affect. Specific Aim 3a: To test whether brain activation can predict food intake during a post-fMRI scan test meal. Hypothesis 3a: On negative- versus neutral-affect days, BN and BED will select more food in a post-fMRI scan test meal; lower DLPFC and higher striatal activation during food choice, and higher (prediction error) taste reward activation in insula and ventral striatum will predict greater food intake. Specific Aim 3b: To test whether brain activation during reward learning or food choice predicts negative affect measured by EMA on the study day, as well as measured between study days in the individual's naturalistic environment. Hypothesis 3b: Insula, ventral striatum and DLPFC activation (taste prediction error task, food choice task) during the negative affect condition will predict the intensity of negative affect immediately after fMRI, as well as intensity of negative affect episodes during the days between brain scans in the individual's naturalistic environment, suggesting a neurobiological affective vulnerability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bulimia Nervosa, Binge-Eating Disorder, Obesity, Eating Disorder

Keywords

fMRI, Reward, Food Choices, Negative Affect

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

410 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Behavioral

Arm Type

Experimental

Arm Description

Negative Affect Task

Intervention Type

Behavioral

Intervention Name(s)

Negative Affect Task

Other Intervention Name(s)

Functional Magnetic Resonance Brain Imaging Stress Task

Intervention Description

fMRI stress task

Primary Outcome Measure Information:

Title

Taste Reward Brain Response to Negative Affect fMRI Task

Description

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

Time Frame

5 years

Title

Food Choice Brain Response to Negative Affect fMRI Task

Description

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

Time Frame

5 years

Title

Brain Activation and Food Intake/negative Affect Relationships

Description

To test whether brain activation predicts food intake or negative affect

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Eating much more rapidly than normal. Eating until feeling uncomfortably full. Eating large amounts of food when not feeling physically hungry. Eating alone because of embarrassment. Feeling disgusted with oneself, depressed, or very guilty after overeating. C. Marked distress regarding binge eating is present. D. At least once a week for 3 months. E. The binge eating is not associated with the recurrent use of inappropriate compensatory behavior. Bulimia Nervosa Age 18-55 years old Edinburgh Handedness Inventory Revised (EHI-R) LQ* score > +200 DSM 5 diagnosis of Bulimia Nervosa A. Recurrent episodes of binge eating Eating, in a discrete period of time, an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances. A sense of lack of control over eating during the episode. B. Recurrent inappropriate compensatory behavior in order to prevent weight gain, such as self-induced vomiting; misuse of laxatives, diuretics, or other medications; fasting; or excessive exercise. C. At least once a week for 3 months. D. Self-evaluation is unduly influenced by body shape and weight. Exclusion Criteria: 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 Major Medical illness Recent history of suspected substance abuse or a lifetime history of psychostimulant abuse and/or dependence Metal implants or braces Binge Eating Disorder Pregnancy or breast feeding within last 3 months Lifetime history of bipolar disorder or psychosis Use of a psychostimulant within the prior 6 months Recent history of substance abuse or dependence (except for alcohol and cannabis use) Major Medical illness Metal implants or braces Bulimia Nervosa Pregnancy or breast feeding within last 3 months Lifetime history of bipolar disorder or psychosis Use of a psychostimulant within the prior 6 months Recent history of substance abuse or dependence (except for alcohol and cannabis use) Major Medical illness Metal implants or braces

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Megan E Shott, BS

Phone

858-246-5272

mshott@ucsd.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Guido KW Frank, MD

Phone

858-246-2053

gfrank@ucsd.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guido KW Frank, MD

Organizational Affiliation

University of California, San Diego

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California at San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92121

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Megan Shott, BS

Phone

858-246-5272

mshott@ucsd.edu

First Name & Middle Initial & Last Name & Degree

Guido Frank, MD

Phone

858-246-2053

gfrank@ucsd.edu

First Name & Middle Initial & Last Name & Degree

Guido KW Frank, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

19631931

Citation

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.

Results Reference

background

PubMed Identifier

25808854

Citation

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.

Results Reference

background

PubMed Identifier

25961467

Citation

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.

Results Reference

background

PubMed Identifier

25865091

Citation

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.

Results Reference

background

PubMed Identifier

26893235

Citation

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.

Results Reference

background

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Effects of Negative Affect in Individuals With Binge Eating Episodes

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