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OpenTrials
Completed

NCT Number: NCT04115852

Interoceptive Nutritional Processing 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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Heidelberg

Heidelberg, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

(for all participants):

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

Treatment and study plan

fmri

Behavioral

functional magnetic resonance imaging

Primary outcomes

  1. the neural correlates of interoceptive nutritional processing

    Time frame: 2-3 weeks

    cross-sectional fMRI

Sponsors and collaborators

Lead sponsor

University of Heidelberg Medical Center

Other

Registry information

Official study title

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

Acronym: BAG-C

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 4, 2019
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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