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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK125651 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Stanford University | OTHER |
| University of Utah | OTHER |
| Gretchen Swanson Center for Nutrition |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fMRI | Experimental | Participants are delivered sips of appetizing tastes (milkshake) and tasteless solution throughout the task while in the MRI scanner. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milkshake fMRI | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy D Nelson, Ph.D. | University of Nebraska Lincoln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska-Lincoln | Lincoln | Nebraska | 68588 | United States |
There is not a plan to make IPD available
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | activation beta value | 7 seconds after cue is presented |
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During the session in which the milkshake task trial was conducted
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Nelson | University of Nebraska-Lincoln | 4024727707 | tnelson3@unl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2025 | Dec 19, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 27, 2025 | May 14, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
| Wayne State University | OTHER |
All participants complete the same fMRI protocol which includes delivery of appetizing taste stimuli and tasteless stimuli while in the scanner.
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| 7 seconds after delivery of sip |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| 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. | Posted | Mean | Standard Deviation | activation beta value | 7 seconds after cue is presented |
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| 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. | Posted | Mean | Standard Deviation | activation beta value | 7 seconds after cue is presented |
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| 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. | Posted | Mean | Standard Deviation | activation beta value | 7 seconds after delivery of sip |
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| 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. | Posted | Mean | Standard Deviation | activation beta value | 7 seconds after delivery of sip |
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| 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. | Posted | Mean | Standard Deviation | activation beta value | 7 seconds after delivery of sip |
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| 0 |
| 187 |
| 0 |
| 187 |
| 0 |
| 187 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |