Modifiable Predictors of Neural Vulnerabilities for Obesity

NCT ID: NCT04522947

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-30
• Study Completion Date: 2025-04-24

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

fMRI

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

Group Type: EXPERIMENTAL

Milkshake fMRI

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: collaborator

Gretchen Swanson Center for Nutrition

OTHER

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: collaborator

University of Nebraska Lincoln

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy D Nelson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska Lincoln

Locations

University of Nebraska-Lincoln

Lincoln, Nebraska, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DK125651

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20317

Identifier Type: -

Identifier Source: org_study_id