ObesityNCT04522947
Modifiable Predictors of Neural Vulnerabilities for Obesity
A study testing Milkshake fMRI in people with Obesity, run by University of Nebraska Lincoln at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Milkshake fMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2020to 24 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska-Lincoln
Lincoln, Nebraska, 68588
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Milkshake fMRI
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milkshake fMRIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| fMRI | Experimental | Participants are delivered sips of appetizing tastes (milkshake) and tasteless solution throughout the task while in the MRI scanner. Receives: Other: Milkshake fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caudate Activation for Sip Cue
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.
Measured: 7 seconds after cue is presented
Putamen Activation for Sip Cue
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.
Measured: 7 seconds after cue is presented
Insula Activation for Sip Cue
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.
Measured: 7 seconds after cue is presented
Caudate Activation for Sip Delivery
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.
Measured: 7 seconds after delivery of sip
Putamen Activation for Sip Delivery
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.
Measured: 7 seconds after delivery of sip
Insula Activation for Sip Delivery
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.
Measured: 7 seconds after delivery of sip
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start30 Oct 2020
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants complete the same fMRI protocol which includes delivery of appetizing taste stimuli and tasteless stimuli while in the scanner.
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, University of Utah, Gretchen Swanson Center for Nutrition, Wayne State University
- Responsible party
- Sponsor
- Investigators
- Timothy D Nelson, Ph.D., Principal investigator, University of Nebraska Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522947
- Sponsor's protocol ID
- 20317
- Other IDs
- R01DK125651
- Status last verified
- Dec 2025
- First submitted
- 13 Aug 2020
- Last updated
- 12 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifiable Predictors of Neural Vulnerabilities for Obesity
- ClinicalTrials.gov ID
- NCT04522947
- Acronym / sponsor ID
- 20317
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, University of Utah, Gretchen Swanson Center for Nutrition, Wayne State University
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Posted 12 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants complete the same fMRI protocol which includes delivery of appetizing taste stimuli and tasteless stimuli while in the scanner.
| Arm | Type | Receives |
|---|---|---|
| fMRI | Experimental | Other: Milkshake fMRIParticipants are delivered sips of appetizing tastes (milkshake) and tasteless solution throughout the task while in the MRI scanner. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- Contraindications for functional magnetic resonance imaging (fMRI):
- metal in body
- pregnancy
- braces
- non-removal piercings
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 |
|---|---|---|
| Milkshake fMRIWhile 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. | Other | fMRI |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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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.
Timothy D Nelson, Ph.D. principal investigator
University of Nebraska Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milkshake fMRI in people with Obesity, run by University of Nebraska Lincoln at 1 site in United States.
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 2 inclusion and 7 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 12 Jan 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 12 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Caudate Activation for Sip Cue (time frame: 7 seconds after cue is presented). The study lists 6 primary outcomes in all. 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 12 Jan 2026.