Food HabitsBAG-CNCT04115852
Interoceptive Nutritional Processing in Healthy Participants and Patients With Binge-Eating-Disorder
An observational study of Food Habits and Binge-Eating Disorder, run by University of Heidelberg Medical Center at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Habits, Binge-Eating Disorder
- What is being tested?
- fmri
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2019to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will enroll 25 patients with BED. Patients will be recruited from the investigator's in- and out-patient department or by public advertisement after giving their written informed consent. Additionally, a healthy control group of 25 participants will be recruited by public advertisement.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Neural Correlates of Interoceptive Nutritional Processing Using fMRI 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
- Conditions
- Food Habits, Binge-Eating Disorder
- Being tested
- fmri
- Keywords
- fmri, interoceptive food processing
- Medical subject headings
- Feeding Behavior, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fmriBehavioural
functional magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| CON | Healthy Controls Receives: Behavioral: fmri | |
| BED | Patients with Binge-Eating-Disorder Receives: Behavioral: fmri |
What is being measured
The primary outcome is the main question the study is designed to answer.
the neural correlates of interoceptive nutritional processing
cross-sectional fMRI
Measured: 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start1 Sep 2019
- Primary completion1 Aug 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Heidelberg Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Simon, University of Heidelberg Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115852
- Sponsor's protocol ID
- S-545/2019
- Acronym
- BAG-C
- Status last verified
- Jan 2023
- First submitted
- 2 Oct 2019
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Neural Correlates of Interoceptive Nutritional Processing Using fMRI in Healthy Participants and Patients With Binge-Eating-Disorder
- ClinicalTrials.gov ID
- NCT04115852
- Acronym / sponsor ID
- BAG-C / S-545/2019
- Conditions
- Food Habits, Binge-Eating Disorder
- Keywords
- fmri, interoceptive food processing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Heidelberg Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 4 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CON | – | Behavioral: fmriHealthy Controls |
| BED | – | Behavioral: fmriPatients with Binge-Eating-Disorder |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will enroll 25 patients with BED. Patients will be recruited from the investigator's in- and out-patient department or by public advertisement after giving their written informed consent. Additionally, a healthy control group of 25 participants will be recruited by public advertisement.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- History of head injury or surgery
- History of neurological disorder
- Severe psychiatric comorbidity (psychosis, bipolar disorder, substance abuse)
- Smoking
- Borderline personality disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fmrifunctional magnetic resonance imaging | Behavioural | BED, CON |
Primary outcome
the neural correlates of interoceptive nutritional processing
Time frame: 2-3 weeks
cross-sectional fMRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Habits and Binge-Eating Disorder, run by University of Heidelberg Medical Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the neural correlates of interoceptive nutritional processing (time frame: 2-3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.