We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Homeostatic and Non-homeostatic Processing of Food Cues in Anorexia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03075371
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : October 3, 2019
German Research Foundation
Information provided by (Responsible Party):
Joe Simon, University of Heidelberg Medical Center

Brief Summary:
The goal of the present study is to investigate metabolic gut-brain signaling and the neural correlates of distraction from visual food cues in patients with Anorexia nervosa and healthy controls.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Healthy Other: Glucose Other: Placebo Not Applicable

Detailed Description:
Anorexia nervosa (AN) is an eating disorder with high morbidity and lifetime mortality. This eating disorder is mainly characterized by restricted food intake despite a severely low body weight. Given the pronounced self-starvation in AN, the investigation of homeostatic food processing, and its interaction with the reward system is of great scientific interest. Previous research in AN patients has almost exclusively focused on cortical, non-homeostatic (e.g., reward related) food processing. Therefore, the primary aim of the present study is to investigate metabolic gut-brain signaling by focusing on the responsivity of the hypothalamus (i.e., the core region of homeostatic control) and the mesocorticolimbic reward system. A secondary aim is to study the interaction between the mesocorticolimbic reward system and the homeostatic (i.e., hypothalamus) system. Metabolic gut-brain signaling will be assessed by applying a single-blind, randomized, crossover design of intragastric infusion of glucose or water. 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) in AN patients and healthy controls. Furthermore, we will measure how cognitive strategies to control the desire for visual food cues (top-down control) affect the mesocorticolimbic and hypothalamic systems in AN patients differently than in healthy controls. The interaction between the hypothalamus and the mesocorticolimbic reward system will be investigated using an effective connectivity analysis. Functional magnetic resonance imaging with high spatial resolution and with an optimized protocol for the investigation of the hypothalamus and the mesocorticolimbic reward system will be used to study for the first time homeostatic and non-homeostatic food cue processing in AN patients.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Homeostatic and Non-homeostatic Processing of Food Cues in Anorexia Nervosa
Actual Study Start Date : September 2014
Actual Primary Completion Date : December 2018
Actual Study Completion Date : February 2019

Arm Intervention/treatment
Active Comparator: intragastric glucose administration Other: Glucose
75 g of glucose dissolved in 300 ml of water

Placebo Comparator: intragastric water administration Other: Placebo
300 ml of tap water

Primary Outcome Measures :
  1. Resting state brain activity using fMRI [ Time Frame: 35 min ]
    Functional brain imaging will be employed to assess metabolic gut-brain signaling during a single blind, randomized cross-over design of gastric glucose vs. water infusion.

  2. Experimental fMRI task [ Time Frame: 20 min ]
    Participants will be asked to either view food or nonfood images or to down-regulate their emotional response by distracting themselves from the stimuli by solving an arithmetic task.

Secondary Outcome Measures :
  1. Analysis of hormonal satiety signaling [ Time Frame: 30 min before scanning, 30 min after intragastric feeding, 60 min after intragastric feeding ]
    Blood is collected for the measurement of peripheral ghrelin. In total, three blood samples will be collected.

  2. Self-report questionnaire regarding eating behavior (Dutch Eating Behavior Questionnaire) [ Time Frame: 30 min ]
    Psychometric tests will be employed to assess eating behavior and eating disorder psychopathology (using the Dutch Eating Behavior Questionnaire).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • patients that meet the diagnostic criteria for AN (DSM-V criteria)
  • Medically stable patients with a BMI < 17.5 kg/m² and > 13 kg/m²; Healthy controls with a BMI <25 kg/m² and >18.5 kg/m²
  • Over Age of 18 years
  • no other lifetimes or current medical illness that could potentially affect appetite or body weight
  • right-handedness
  • normal or corrected-to-normal vision

Exclusion Criteria:

  • 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 scanning (e.g. metallic implants, claustrophobia, Pacemakers)
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075371

Layout table for location information
University Hospital Heidelberg
Heidelberg, Germany
Sponsors and Collaborators
University of Heidelberg Medical Center
German Research Foundation
Layout table for investigator information
Principal Investigator: Joe Simon, Dr. Dipl. Psych. University Hospital Heidelberg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Joe Simon, Principal Investigator, University of Heidelberg Medical Center
ClinicalTrials.gov Identifier: NCT03075371    
Other Study ID Numbers: UHeidelbergMedCtr
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders