Homeostatic and Non-homeostatic Processing of Food Cues in Anorexia Nervosa
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ClinicalTrials.gov Identifier: NCT03075371 |
Recruitment Status :
Completed
First Posted : March 9, 2017
Last Update Posted : October 3, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anorexia Nervosa Healthy | Other: Glucose Other: Placebo | Not Applicable |
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 |
- 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.
- 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.
- 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.
- 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).

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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

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
Germany | |
University Hospital Heidelberg | |
Heidelberg, Germany |
Principal Investigator: | Joe Simon, Dr. Dipl. Psych. | University Hospital Heidelberg |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Anorexia Anorexia Nervosa Signs and Symptoms, Digestive Feeding and Eating Disorders Mental Disorders |