- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03081585
Food Reward Processing in the Human Brain
March 28, 2022 updated by: Joe Simon, University of Heidelberg Medical Center
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
23
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 to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Healthy normal weight female participants
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy Controls
Normal weight, healthy female participants
|
Participants were scanned twice: once after a meal and once after fasting for 24 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
22 min.
|
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.
|
5 min.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis of hormonal satiety signaling
Time Frame: 30 min. before scanning
|
Blood is collected for the measurement of peripheral ghrelin.
One blood sample at the start of the experiment will be collected.
|
30 min. before scanning
|
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.
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.
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)
June 9, 2015
Primary Completion (Actual)
June 10, 2016
Study Completion (Actual)
June 10, 2016
Study Registration Dates
First Submitted
March 10, 2017
First Submitted That Met QC Criteria
March 15, 2017
First Posted (Actual)
March 16, 2017
Study Record Updates
Last Update Posted (Actual)
March 29, 2022
Last Update Submitted That Met QC Criteria
March 28, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- NSM
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
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Satiety State
-
Laval UniversityAliments ULTIMA Foods Inc.Completed
-
Wake Forest University Health SciencesCompleted
-
Federico II UniversityCompleted
-
GlaxoSmithKlineCompleted
-
Daewoong Pharmaceutical Co. LTD.Hanyang UniversityUnknownErosive EsophagitisKorea, Republic of
-
The Netherlands Cancer InstituteEnrolling by invitation
-
The Hillshire Brands CompanyBiofortis Clinical Research, Inc.Unknown
-
Konkuk University Medical CenterDaewoong Pharmaceutical Co. LTD.RecruitingErosive EsophagitisKorea, Republic of
-
Solae, LLCGlycemic Index Laboratories, IncCompleted