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

Binge-Eating Disorder Clinical Trial

— BAG-C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04115852
• Other study ID #: S-545/2019
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2023
• Source: University of Heidelberg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders
• Food Habits

Intervention

Behavioral:
• fmri
functional magnetic resonance imaging

Locations

Country	Name	City	State
Germany	University Hospital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Heidelberg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the neural correlates of interoceptive nutritional processing	cross-sectional fMRI	2-3 weeks