Interoceptive Nutritional Processing in Healthy Participants and Patients With Binge-Eating-Disorder (BAG-C)

Investigating the Neural Correlates of Interoceptive Nutritional Processing Using fMRI in Healthy Participants and Patients With Binge-Eating-Disorder

Binge-Eating-Disorder (BED) is a common eating disorder characterized by recurring episodes of uncontrollable eating. The underlying neural mechanisms are largely unknown. However, dysfunctional hormonal satiety signaling as well as dysfunctional neural processing of food cues are discussed as possible casual factors in the development and maintenance of this disorder. Additional research is needed to specify the exact contribution of these observations and how they interact with each other. Accordingly, the current study plans to investigate metabolic gut-brain signaling to better understand the underlying causes of abnormal eating behavior. To this end, 25 healthy normal weight control participants as well as 25 patients with BED will be recruited. The responsivity of the hypothalamus (i.e., the core region of homeostatic control) and its interaction with the mesocorticolimbic reward system will be assessed by applying a single-blind, randomized, crossover design of intravenous infusion of glucose or NaCl. This approach allows the study of gut-brain signaling to the hypothalamus and the reward system by controlling for sensory aspects of food intake (sight, smell, and taste). The interaction between the hypothalamus and the mesocorticolimbic reward system will be investigated using an effective connectivity analysis. FMRI with high spatial resolution and with an optimized protocol for the investigation of the hypothalamus and the mesocorticolimbic reward system will be employed. A better understanding of the underlying psychobiological mechanisms of BED is a fundamental requirement for the development of improved prevention and treatment strategies

Study Overview

• Status: Completed
• Conditions: Binge-Eating Disorder; Food Habits
• Intervention / Treatment: Behavioral: fmri

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany
    • University Hospital Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will enroll 25 patients with BED. Patients will be recruited from the investigator's in- and out-patient department or by public advertisement after giving their written informed consent. Additionally, a healthy control group of 25 participants will be recruited by public advertisement.

Description

Inclusion criteria:

1. patients that meet the diagnostic criteria for BED
2. Over age of 18 years.
3. Right-handedness.
4. Normal or corrected-to-normal vision.
5. No other lifetime or current medical illness that could potentially affect appetite or body weight

Exclusion criteria (for all participants):

1. History of head injury or surgery
2. History of neurological disorder
3. Severe psychiatric comorbidity (psychosis, bipolar disorder, substance abuse)
4. Smoking
5. Borderline personality disorder
6. Current psychotropic medication
7. Inability to undergo fMRI scan (e.g. metallic implants, claustrophobia, pacemakers)
8. Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CON; Healthy Controls	Behavioral: fmri; functional magnetic resonance imaging
BED; Patients with Binge-Eating-Disorder	Behavioral: fmri; functional magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the neural correlates of interoceptive nutritional processing	cross-sectional fMRI	2-3 weeks

Collaborators and Investigators

• Sponsor: University of Heidelberg Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: fmri; interoceptive food processing
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
• Other Study ID Numbers: S-545/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No