HealthyNCT03081585
Food Reward Processing in the Human Brain
An observational study of Healthy, run by University of Heidelberg Medical Center.
Trial summary
The aim of this study is to investigate the influence of different metabolic states and hormonal satiety signalling on responses in neural reward networks. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Satiety State
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 9 Jun 2015to 10 Jun 2016
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy normal weight female participants
Who may be able to join
- BMI <25 kg/m² and >18.5 kg/m²
- no lifetime or current medical illness that could potentially affect appetite or body weight
- right-handedness
- normal or corrected-to-normal vision
Who cannot join
- history of head injury or surgery
- history of neurological disorder
- severe psychiatric disorder (psychosis, bipolar disorder, substance abuse)
- smoking
- borderline personality disorder
- current psychotropic medication
- inability to undergo fMRI scanning (e.g. metallic implants, claustrophobia, Pacemakers)
- pregnancy
About this study
Official title: Integration of Homeostatic Signaling and Food Reward Processing in the Human Brain
The aim of this study is to investigate the influence of different metabolic states and hormonal satiety signalling on responses in neural reward networks.
Read the detailed description
Given the rapid development of obesity world-wide, a better understanding of the interaction between the encoding of food reward in mesocorticolimbic reward pathways and homeostatic energy regulation is of paramount importance for the development of new treatment strategies. Healthy participants will undergo functional magnetic resonance imaging while performing a task distinguishing between the anticipation and the receipt of either food or monetary reward. Every participant will be scanned twice in a counterbalanced fashion, both during a state of hunger (after 24-hours fasting) and satiety. Blood samples will be collected to assess hormonal satiety signalling. We hope to provide new insights into the neurobiological underpinnings of motivational processing and hedonic evaluation of food reward.
- Conditions
- Healthy
- Being tested
- Satiety State
- Keywords
- fmri, neuronal reward processing, hormonal satiety signalling, fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Satiety StateBehavioural
Participants were scanned twice: once after a meal and once after fasting for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Normal weight, healthy female participants Receives: Behavioral: Satiety State |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experimental fMRI task (incentive delay task)
Participants were expecting food and monetary related reward, after a correct response to a simple task they received either food or monetary related reward.
Measured: 22 min.
Resting state brain activity using functional magnetic resonance imaging
Functional brain imaging will be employed to assess functional connectivity in reward related brain networks.
Measured: 5 min.
Secondary outcomes (2)
Analysis of hormonal satiety signaling
Blood is collected for the measurement of peripheral ghrelin. One blood sample at the start of the experiment will be collected.
Measured: 30 min. before scanning
Self-report questionnaire regarding eating behavior (Dutch Eating Behavior Questionnaire)
Psychometric tests will be employed to assess eating behavior and eating disorder psychopathology (using the Dutch Eating Behavior Questionnaire).
Measured: 30 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start9 Jun 2015
- Primary completion10 Jun 2016
- Study completion10 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 23 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
- Investigators
- Joe Simon, Dr. Dipl. Psych., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081585
- Sponsor's protocol ID
- NSM
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2017
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simon JJ, Wetzel A, Sinno MH, Skunde M, Bendszus M, Preissl H, Enck P, Herzog W, Friederich HC. Integration of homeostatic signaling and food reward processing in the human brain. JCI Insight. 2017 Aug 3;2(15):e92970. doi: 10.1172/jci.insight.92970. eCollection 2017 Aug 3.
PubMed 28768906
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Homeostatic Signaling and Food Reward Processing in the Human Brain
- ClinicalTrials.gov ID
- NCT03081585
- Acronym / sponsor ID
- NSM
- Conditions
- Healthy
- Keywords
- fmri, neuronal reward processing, hormonal satiety signalling, fasting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Heidelberg Medical CenterUniversity, hospital or other
- Study start
- 9 Jun 2015 (actual)
- Primary completion
- 10 Jun 2016 (actual)
- Study completion
- 10 Jun 2016 (actual)
- First posted
- 16 Mar 2017 (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.
The aim of this study is to investigate the influence of different metabolic states and hormonal satiety signalling on responses in neural reward networks.
Detailed description
Given the rapid development of obesity world-wide, a better understanding of the interaction between the encoding of food reward in mesocorticolimbic reward pathways and homeostatic energy regulation is of paramount importance for the development of new treatment strategies. Healthy participants will undergo functional magnetic resonance imaging while performing a task distinguishing between the anticipation and the receipt of either food or monetary reward. Every participant will be scanned twice in a counterbalanced fashion, both during a state of hunger (after 24-hours fasting) and satiety. Blood samples will be collected to assess hormonal satiety signalling. We hope to provide new insights into the neurobiological underpinnings of motivational processing and hedonic evaluation of food reward.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Behavioral: Satiety StateNormal weight, healthy female participants |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy normal weight female participants
Key inclusion criteria (4 listed)
- BMI <25 kg/m² and >18.5 kg/m²
- no lifetime or current medical illness that could potentially affect appetite or body weight
- right-handedness
- normal or corrected-to-normal vision
Key exclusion criteria (8 listed)
- history of head injury or surgery
- history of neurological disorder
- severe psychiatric disorder (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 |
|---|---|---|
| Satiety StateParticipants were scanned twice: once after a meal and once after fasting for 24 hours | Behavioural | Healthy Controls |
Primary outcome
Experimental fMRI task (incentive delay task)
Time frame: 22 min.
Participants were expecting food and monetary related reward, after a correct response to a simple task they received either food or monetary related reward.
Resting state brain activity using functional magnetic resonance imaging
Time frame: 5 min.
Functional brain imaging will be employed to assess functional connectivity in reward related brain networks.
2 secondary outcomes
Analysis of hormonal satiety signaling
Time frame: 30 min. before scanning
Self-report questionnaire regarding eating behavior (Dutch Eating Behavior Questionnaire)
Time frame: 30 min.
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 29 Mar 2022.
- Derived from this study: PubMed 28768906Simon JJ, Wetzel A, Sinno MH, Skunde M, Bendszus M, Preissl H, Enck P, Herzog W, Friederich HC. Integration of homeostatic signaling and food reward processing in the human brain. JCI Insight. 2017 Aug 3;2(15):e92970. doi: 10.1172/jci.insight.92970. eCollection 2017 Aug 3.
- Individual participant dataSharing planned: No
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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.
Joe Simon, Dr. Dipl. Psych. principal investigator
University Hospital Heidelberg
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Heidelberg Medical Center.
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 4 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 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Experimental fMRI task (incentive delay task) (time frame: 22 min.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03081585, which also lists 1 linked publication.
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 29 Mar 2022.