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CompletedNCT04522947Updated Jan 12, 2026Results posted

Modifiable Predictors of Neural Vulnerabilities for Obesity

An interventional study of Milkshake fMRI in Obesity, sponsored by University of Nebraska Lincoln. Completed at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-12.

Sponsored by University of Nebraska Lincoln · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
187
Allocation
Not applicable
Ages
19 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Obesity

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03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's enrollment of 187 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

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Lead sponsor

University of Nebraska Lincoln is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
187 participants (actual)

Study arms

  • Experimental
    fMRI

    Participants are delivered sips of appetizing tastes (milkshake) and tasteless solution throughout the task while in the MRI scanner.

    Other: Milkshake fMRI

Interventions

  • OtherMilkshake fMRI

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 seconds after cue is presented

  2. 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.

    Time frame: 7 seconds after cue is presented

  3. 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.

    Time frame: 7 seconds after cue is presented

  4. 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.

    Time frame: 7 seconds after delivery of sip

  5. 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.

    Time frame: 7 seconds after delivery of sip

  6. 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.

    Time frame: 7 seconds after delivery of sip

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Results

Posted Jan 12, 2026

Participant flow

Participant flow — Overall Study
MilestonefMRI Milkshake Task
Started187
Completed187
Not completed0

Outcome measures

PrimaryCaudate 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.

Time frame:
7 seconds after cue is presented
Reported as:
Mean · activation beta value
Caudate Activation for Sip Cue
activation beta valuefMRI
Caudate Activation for Sip Cue-0.026264341 ± 0.261413915
PrimaryPutamen 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.

Time frame:
7 seconds after cue is presented
Reported as:
Mean · activation beta value
Putamen Activation for Sip Cue
activation beta valuefMRI
Putamen Activation for Sip Cue-0.020653429 ± 0.23259893
PrimaryInsula 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.

Time frame:
7 seconds after cue is presented
Reported as:
Mean · activation beta value
Insula Activation for Sip Cue
activation beta valuefMRI
Insula Activation for Sip Cue-0.058804599 ± 0.1660244
PrimaryCaudate 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.

Time frame:
7 seconds after delivery of sip
Reported as:
Mean · activation beta value
Caudate Activation for Sip Delivery
activation beta valuefMRI
Caudate Activation for Sip Delivery-0.01520067 ± 0.269324341
PrimaryPutamen 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.

Time frame:
7 seconds after delivery of sip
Reported as:
Mean · activation beta value
Putamen Activation for Sip Delivery
activation beta valuefMRI
Putamen Activation for Sip Delivery-0.010750489 ± 0.211345119
PrimaryInsula 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.

Time frame:
7 seconds after delivery of sip
Reported as:
Mean · activation beta value
Insula Activation for Sip Delivery
activation beta valuefMRI
Insula Activation for Sip Delivery0.084583225 ± 0.173758221

Adverse events

Collected over During the session in which the milkshake task trial was conducted. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
fMRI Milkshake Task0/187 (0%)0/187 (0%)0/187 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)fMRI Milkshake Task
<=18 years0
Between 18 and 65 years187
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)fMRI Milkshake Task
Female113
Male74
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)fMRI Milkshake Task
Hispanic or Latino21
Not Hispanic or Latino162
Unknown or Not Reported4
Race (NIH/OMB)
Race (NIH/OMB)(Participants)fMRI Milkshake Task
American Indian or Alaska Native1
Asian6
Native Hawaiian or Other Pacific Islander0
Black or African American17
White133
More than one race24
Unknown or Not Reported6
Region of Enrollment
Region of Enrollment(participants)fMRI Milkshake Task
United States187
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Study locations

1 site
  • University of Nebraska-Lincoln
    Lincoln, Nebraska 68588, United States
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References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 19, 2025
  • Informed consent form · Feb 27, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — There is not a plan to make IPD available

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04522947
Lead sponsor
University of Nebraska Lincoln
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
First posted
Aug 21, 2020
Start date
Oct 30, 2020
Primary completion
Apr 24, 2025
Completion
Apr 24, 2025
Results posted
Jan 12, 2026
Last update
Jan 12, 2026

Study contacts

Timothy D Nelson, Ph.D.
principal investigator · University of Nebraska Lincoln

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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