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

• Sponsor: University of Heidelberg Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04115852
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 39
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Food Habits; Binge-Eating Disorder	Behavioral: fmri

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Investigating the Neural Correlates of Interoceptive Nutritional Processing Using fMRI in Healthy Participants and Patients With Binge-Eating-Disorder
• Actual Study Start Date: Sep 1, 2019
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. the neural correlates of interoceptive nutritional processing [2-3 weeks]

   cross-sectional fMRI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Heidelberg	Heidelberg		Germany

Sponsors and Collaborators

• University of Heidelberg Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joe Simon, Principal Investigator, University of Heidelberg Medical Center
• ClinicalTrials.gov Identifier: NCT04115852
• Other Study ID Numbers: S-545/2019
• First Posted: Oct 4, 2019
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Joe Simon, Principal Investigator, University of Heidelberg Medical Center: fmri; interoceptive food processing
• Additional relevant MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder

Study Results

No Results Posted as of Sep 29, 2021