Modifiable Predictors of Neural Vulnerabilities for Obesity

NCT04522947 — Not applicable, Completed, 187 participants, University of Nebraska Lincoln

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RegistryNCT04522947
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, other
Enrollment187 (Actual)
SponsorUniversity of Nebraska Lincoln (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
ConditionsObesity
InterventionsMilkshake fMRI (Other)
Datesstart 2020-10-30, primary completion 2025-04-24, completion 2025-04-24, first posted 2020-08-21, last updated 2026-01-12
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Obesity All trials of Milkshake fMRI

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
fMRIExperimentalOther: Milkshake fMRIParticipants are delivered sips of appetizing tastes (milkshake) and tasteless solution throughout the task while in the MRI scanner.
  • 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.

+Outcome measures

Primary outcomes

  • Caudate Activation for Sip Cue [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 [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 [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 [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 [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 [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.

+Eligibility

Sex: All, ages: 19 Years to any, accepts healthy volunteers

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.

+Posted results

Participant flow

MilestonefMRI Milkshake Task
Started187
Completed187
Not completed0

Outcome results

  • Caudate Activation for Sip Cue (Primary), Mean, activation beta value: fMRI -0.026264341 +/- 0.261413915
  • Putamen Activation for Sip Cue (Primary), Mean, activation beta value: fMRI -0.020653429 +/- 0.23259893
  • Insula Activation for Sip Cue (Primary), Mean, activation beta value: fMRI -0.058804599 +/- 0.1660244
  • Caudate Activation for Sip Delivery (Primary), Mean, activation beta value: fMRI -0.01520067 +/- 0.269324341
  • Putamen Activation for Sip Delivery (Primary), Mean, activation beta value: fMRI -0.010750489 +/- 0.211345119
  • Insula Activation for Sip Delivery (Primary), Mean, activation beta value: fMRI 0.084583225 +/- 0.173758221

Adverse events

Time frame: During the session in which the milkshake task trial was conducted

ArmDeathsSerious adverse eventsOther adverse events
fMRI Milkshake Task0/187 (0.0%)0/187 (0.0%)0/187 (0.0%)

+Locations (1)

FacilityCityCountryStatus
University of Nebraska-LincolnLincoln, NebraskaUnited States

+Study documents

+Investigators

+Funding

NIH grants: R01DK125651