- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03075371
Homeostatic and Non-homeostatic Processing of Food Cues in Anorexia Nervosa
October 2, 2019 updated by: Joe Simon, University of Heidelberg Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Heidelberg, Germany
- University Hospital Heidelberg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: intragastric glucose administration
|
75 g of glucose dissolved in 300 ml of water
|
Placebo Comparator: intragastric water administration
|
300 ml of tap water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
35 min
|
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.
|
20 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 min before scanning, 30 min after intragastric feeding, 60 min after intragastric feeding
|
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).
|
30 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Joe Simon, Dr. Dipl. Psych., University Hospital Heidelberg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Stopyra MA, Friederich HC, Lavandier N, Mönning E, Bendszus M, Herzog W, Simon JJ. Homeostasis and food craving in obesity: a functional MRI study. Int J Obes (Lond). 2021 Nov;45(11):2464-2470. doi: 10.1038/s41366-021-00920-4. Epub 2021 Aug 17.
- Stopyra MA, Friederich HC, Monning E, Lavandier N, Bendszus M, Herzog W, Simon JJ. The influence of homeostatic mechanisms on neural regulation of food craving in anorexia nervosa. Psychol Med. 2021 Apr;51(6):1011-1019. doi: 10.1017/S0033291719003970. Epub 2020 Jan 14.
- Stopyra MA, Friederich HC, Sailer S, Pauen S, Bendszus M, Herzog W, Simon JJ. The effect of intestinal glucose load on neural regulation of food craving. Nutr Neurosci. 2021 Feb;24(2):109-118. doi: 10.1080/1028415X.2019.1600275. Epub 2019 Apr 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2014
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
February 1, 2019
Study Registration Dates
First Submitted
February 28, 2017
First Submitted That Met QC Criteria
March 3, 2017
First Posted (Actual)
March 9, 2017
Study Record Updates
Last Update Posted (Actual)
October 3, 2019
Last Update Submitted That Met QC Criteria
October 2, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHeidelbergMedCtr
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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