NCT04522947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2025

Completed
9 months until next milestone

Results Posted

Study results publicly available

January 12, 2026

Completed
Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

4.5 years

First QC Date

August 13, 2020

Results QC Date

December 19, 2025

Last Update Submit

December 19, 2025

Conditions

Obesity

Outcome Measures

Primary Outcomes (6)

  • 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.

    7 seconds after delivery of sip

Study Arms (1)

fMRI

EXPERIMENTAL

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

Other: Milkshake fMRI

Interventions

Milkshake fMRIOTHER

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.

fMRI

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska-Lincoln

Lincoln, Nebraska, 68588, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Timothy Nelson
Organization
University of Nebraska-Lincoln
tnelson3@unl.edu
4024727707

Study Officials

  • Timothy D Nelson, Ph.D.

    University of Nebraska Lincoln

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All participants complete the same fMRI protocol which includes delivery of appetizing taste stimuli and tasteless stimuli while in the scanner.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 21, 2020

Study Start

October 30, 2020

Primary Completion

April 24, 2025

Study Completion

April 24, 2025

Last Updated

January 12, 2026

Results First Posted

January 12, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available

Locations

US(1)