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Modifiable Predictors of Neural Vulnerabilities for Obesity

Modifiable Predictors of Neural Vulnerabilities for Obesity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04522947
Enrollment
187
Registered
2020-08-21
Start date
2020-10-30
Completion date
2025-04-24
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief 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.

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.

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.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Stanford University
CollaboratorOTHER
University of Utah
CollaboratorOTHER
Gretchen Swanson Center for Nutrition
CollaboratorOTHER
Wayne State University
CollaboratorOTHER
University of Nebraska Lincoln
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

All participants complete the same fMRI protocol which includes delivery of appetizing taste stimuli and tasteless stimuli while in the scanner.

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Caudate Activation for Sip Cue7 seconds after cue is presentedMRI 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 Cue7 seconds after cue is presentedMRI 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 Cue7 seconds after cue is presentedMRI 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 Delivery7 seconds after delivery of sipMRI 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 Delivery7 seconds after delivery of sipMRI 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 Delivery7 seconds after delivery of sipMRI 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
fMRI Milkshake Task
Participants are delivered sips of appetizing tastes (milkshake) and tasteless solution throughout the task while in the MRI scanner. Milkshake 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.
187
Total187

Baseline characteristics

CharacteristicfMRI Milkshake Task
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
187 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
162 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
6 Participants
Race (NIH/OMB)
Black or African American
17 Participants
Race (NIH/OMB)
More than one race
24 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
Race (NIH/OMB)
White
133 Participants
Region of Enrollment
United States
187 participants
Sex: Female, Male
Female
113 Participants
Sex: Female, Male
Male
74 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 187
other
Total, other adverse events
0 / 187
serious
Total, serious adverse events
0 / 187

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
fMRICaudate Activation for Sip Cue-0.026264341 activation beta valueStandard Deviation 0.261413915
Primary

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

ArmMeasureValue (MEAN)Dispersion
fMRICaudate Activation for Sip Delivery-0.01520067 activation beta valueStandard Deviation 0.269324341
Primary

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

ArmMeasureValue (MEAN)Dispersion
fMRIInsula Activation for Sip Cue-0.058804599 activation beta valueStandard Deviation 0.1660244
Primary

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

ArmMeasureValue (MEAN)Dispersion
fMRIInsula Activation for Sip Delivery0.084583225 activation beta valueStandard Deviation 0.173758221
Primary

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

ArmMeasureValue (MEAN)Dispersion
fMRIPutamen Activation for Sip Cue-0.020653429 activation beta valueStandard Deviation 0.23259893
Primary

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

ArmMeasureValue (MEAN)Dispersion
fMRIPutamen Activation for Sip Delivery-0.010750489 activation beta valueStandard Deviation 0.211345119

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026