Trial Outcomes & Findings for Modifiable Predictors of Neural Vulnerabilities for Obesity (NCT NCT04522947)

NCT ID: NCT04522947

Last Updated: 2026-01-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

187 participants

Primary outcome timeframe

7 seconds after cue is presented

Results posted on

2026-01-12

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
187
Overall Study
COMPLETED
187
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modifiable Predictors of Neural Vulnerabilities for Obesity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
fMRI Milkshake Task
n=187 Participants
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.
Age, Categorical
<=18 years
0 Participants
n=210 Participants
Age, Categorical
Between 18 and 65 years
187 Participants
n=210 Participants
Age, Categorical
>=65 years
0 Participants
n=210 Participants
Sex: Female, Male
Female
113 Participants
n=210 Participants
Sex: Female, Male
Male
74 Participants
n=210 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
21 Participants
n=210 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
162 Participants
n=210 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
n=210 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=210 Participants
Race (NIH/OMB)
Asian
6 Participants
n=210 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=210 Participants
Race (NIH/OMB)
Black or African American
17 Participants
n=210 Participants
Race (NIH/OMB)
White
133 Participants
n=210 Participants
Race (NIH/OMB)
More than one race
24 Participants
n=210 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
n=210 Participants
Region of Enrollment
United States
187 participants
n=210 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
fMRI
n=187 Participants
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.
Caudate Activation for Sip Cue
-0.026264341 activation beta value
Standard Deviation 0.261413915

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
fMRI
n=187 Participants
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.
Putamen Activation for Sip Cue
-0.020653429 activation beta value
Standard Deviation 0.23259893

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
fMRI
n=187 Participants
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.
Insula Activation for Sip Cue
-0.058804599 activation beta value
Standard Deviation 0.1660244

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
fMRI
n=187 Participants
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.
Caudate Activation for Sip Delivery
-0.01520067 activation beta value
Standard Deviation 0.269324341

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
fMRI
n=187 Participants
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.
Putamen Activation for Sip Delivery
-0.010750489 activation beta value
Standard Deviation 0.211345119

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
fMRI
n=187 Participants
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.
Insula Activation for Sip Delivery
0.084583225 activation beta value
Standard Deviation 0.173758221

Adverse Events

fMRI Milkshake Task

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Timothy Nelson

University of Nebraska-Lincoln

Phone: 4024727707

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place