Interoceptive Nutritional Processing in Healthy Participants and Patients With Binge-Eating-Disorder

NCT ID: NCT04115852

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-12-01

Brief Summary

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

Conditions

Food Habits; Binge-Eating Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

CON

Healthy Controls

fmri

Intervention Type: BEHAVIORAL

functional magnetic resonance imaging

BED

Patients with Binge-Eating-Disorder

fmri

Intervention Type: BEHAVIORAL

functional magnetic resonance imaging

Interventions

fmri

functional magnetic resonance imaging

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Heidelberg Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Joe Simon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Heidelberg

Heidelberg, , Germany

Countries

Germany

Other Identifiers

S-545/2019

Identifier Type: -

Identifier Source: org_study_id