- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04522947
Modifiable Predictors of Neural Vulnerabilities for Obesity
December 19, 2025 updated by: University of Nebraska Lincoln
The purpose of this study is to examine patterns of neural activation in a priori selected brain regions associated with reward process during anticipation and delivery of appetizing food stimuli (milkshake sips) among young adults.
Study Overview
Detailed Description
This observational trial seeks to examine neural activation patterns in a food reward sensitivity task.
The study uses the "milkshake" MRI task to assess individual food reward sensitivity in a sample of young adult participants.
Participants are presented with a series of trials in which a visual cue is provided (either a glass of milkshake or water), followed by delivery of a sip of the corresponding liquid.
Activation in a priori regions associated with reward processing is measured via blood oxygen level-dependent (BOLD) signal, both in response to the cue and actual delivery of the sip.
Explicating patterns of reward processing for appetizing food stimuli holds potential to inform understanding of the neural underpinnings of obesity risk.
Study Type
Interventional
Enrollment (Actual)
187
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
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68588
- University of Nebraska-Lincoln
-
-
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
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age 19 years or older
- Previous participation in the Preschool Problem Solving Study OR lived in Lancaster County, NE for at least part of high school
Exclusion Criteria:
- Contraindications for functional magnetic resonance imaging (fMRI):
- metal in body
- pregnancy
- braces
- non-removal piercings
- hair extensions
- As of 8/13/21, for individuals who were not in the Preschool Problem Solving Study but are invited to participate in the current study because they lived in Lancaster County for at least part of high school, the maximum age for eligibility is 20 years of age.
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: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: fMRI
Participants are delivered sips of appetizing tastes (milkshake) and tasteless solution throughout the task while in the MRI scanner.
|
While in the MRI scanner, the participant is shown a cue indicating the impending delivery of either milkshake or tasteless solution, followed by a brief blank screen, then delivery of the sip, and then a swallow cue.
This procedure is repeated throughout the task.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caudate Activation for Sip Cue
Time Frame: 7 seconds after cue is presented
|
MRI blood oxygen level-dependent (BOLD) activity signal in the caudate for all milkshake cue trials versus all tasteless solution cue trials (milkshake>tasteless) after receiving the cue but before the delivery of the actual sip.
|
7 seconds after cue is presented
|
|
Putamen Activation for Sip Cue
Time Frame: 7 seconds after cue is presented
|
MRI blood oxygen level-dependent (BOLD) activity signal in the putamen for all milkshake cue trials versus all tasteless solution cue trials (milkshake>tasteless) after receiving the cue but before the delivery of the actual sip.
|
7 seconds after cue is presented
|
|
Insula Activation for Sip Cue
Time Frame: 7 seconds after cue is presented
|
MRI blood oxygen level-dependent (BOLD) activity signal in the insula for all milkshake cue trials versus all tasteless solution cue trials (milkshake>tasteless) after receiving the cue but before the delivery of the actual sip.
|
7 seconds after cue is presented
|
|
Caudate Activation for Sip Delivery
Time Frame: 7 seconds after delivery of sip
|
MRI blood oxygen level-dependent (BOLD) activity signal in the caudate for all milkshake trials versus all tasteless solution trials (milkshake>tasteless) upon delivery of the actual sip.
|
7 seconds after delivery of sip
|
|
Putamen Activation for Sip Delivery
Time Frame: 7 seconds after delivery of sip
|
MRI blood oxygen level-dependent (BOLD) activity signal in the putamen for all milkshake trials versus all tasteless solution trials (milkshake>tasteless) upon delivery of the actual sip.
|
7 seconds after delivery of sip
|
|
Insula Activation for Sip Delivery
Time Frame: 7 seconds after delivery of sip
|
MRI blood oxygen level-dependent (BOLD) activity signal in the insula for all milkshake trials versus all tasteless solution trials (milkshake>tasteless) upon delivery of the actual sip.
|
7 seconds after delivery of sip
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Timothy D Nelson, Ph.D., University of Nebraska Lincoln
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)
October 30, 2020
Primary Completion (Actual)
April 24, 2025
Study Completion (Actual)
April 24, 2025
Study Registration Dates
First Submitted
August 13, 2020
First Submitted That Met QC Criteria
August 18, 2020
First Posted (Actual)
August 21, 2020
Study Record Updates
Last Update Posted (Estimated)
January 12, 2026
Last Update Submitted That Met QC Criteria
December 19, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20317
- R01DK125651 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is not a plan to make IPD available
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 Obesity
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
Clinical Trials on Milkshake fMRI
-
Maastricht University Medical CenterCompletedVascular Function | Carbohydrates | Postprandial Metabolism | Proteins | Dietary Fats | MacronutrientsNetherlands
-
University of ReadingMinistry of National Education, TurkeyCompletedPhysical Activity | Gastric Emptying | Appetitive Behavior | Energy IntakeUnited Kingdom
-
University of AberdeenUniversity of DundeeCompleted
-
Weill Medical College of Cornell UniversityMemorial Sloan Kettering Cancer CenterWithdrawnBrain TumorsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedMalignant NeoplasmUnited States
-
Brighton & Sussex Medical SchoolCompletedDepressionUnited Kingdom
-
Van Boven, Robert W., M.D.Massachusetts Institute of Technology; The Geneva FoundationUnknownTraumatic Brain Injury | Post Traumatic Stress DisorderUnited States