The Influence of Obesity and Insulin Sensitivity on Reward Processing and Decision Making (No acronym)

June 5, 2026 updated by: Mary Elizabeth Baugh, Virginia Polytechnic Institute and State University
Reward learning and decision-making processes, which operate largely outside of conscious control, shape food choices and eating behaviors. Excess adiposity is associated with differences in brain structure and functional connectivity underlying these processes, and insulin resistance, which commonly co-occurs with excess adiposity, has been linked with dopamine signaling that is crucial for these processes. However, whether and how excess adiposity and insulin resistance affect reward learning and decision-making remains poorly understood. This study will address that gap, examining the effects of excess adiposity and insulin resistance, and their interaction, on processes of reward learning and decision-making in food-specific and general contexts.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 to 45 years of age
  • Self-reported weight stable (within 5 lbs) for previous 3 months
  • Not pregnant or planning to become pregnant during study participation
  • Weigh more than 110 lbs (due to blood draws used in study)
  • Residing in Roanoke, VA, area and/or willing to attend sessions at the Fralin Biomedical Research Institute

Exclusion criteria:

  • BMI < 18.5 or > 40 kg/m2
  • Hemoglobin A1c > 6.4%
  • Fasting blood glucose > 126 mg/dL
  • 2-hour blood glucose > 200 mg/dL
  • Self-reported current diagnosis of diabetes or other endocrine/metabolic disorder
  • Self-reported current inhaled nicotine use
  • Self-reported history of alcohol dependence
  • Self-reported use of medications known to influence study measures (including antiglycemic agents, thyroid medications, etc.)
  • Self-reported neurological or psychological disorder
  • Self-reported claustrophobia or discomfort with mock fMRI training
  • Self-reported history of head injury resulting in loss of consciousness for more than 10 minutes
  • Contraindications to MRI, including pacemaker, aneurysm clip, neurostimulator, cochlear implant, metal in eyes, steel worker, other implants
  • Self-reported previous metabolic/weight loss surgery
  • Self-reported adherence to special or restrictive diet within the past 3 months (e.g., low-carb, ketogenic, exclusion of food groups/specific macronutrients, etc.)
  • Self-reported allergy to ingredient used in the study drinks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conditioned Stimulus- First, Then Conditioned Stimulus +
Participants will consume the Conditioned Stimulus (CS) - experimental drink 6 times during flavor-nutrient conditioning sessions. Then, they will consumes the CS+ experimental drink 6 times during flavor-nutrient conditioning sessions.
Other: Beverage: Conditioned Stimulus -
Participants will consume flavored beverage solutions sweetened with sucralose during 6 conditioning sessions.
Other: Beverage: Conditioned Stimulus +
Participants will consume flavored beverage solutions sweetened with sucralose and containing 110 calories of maltodextrin during 6 conditioning sessions.
Experimental: Conditioned Stimulus + First, Then Conditioned Stimulus -
Participants will consume the Conditioned Stimulus (CS) + experimental drink 6 times during flavor-nutrient conditioning sessions. Then, they will consumes the CS- experimental drink 6 times during flavor-nutrient conditioning sessions.
Other: Beverage: Conditioned Stimulus -
Participants will consume flavored beverage solutions sweetened with sucralose during 6 conditioning sessions.
Other: Beverage: Conditioned Stimulus +
Participants will consume flavored beverage solutions sweetened with sucralose and containing 110 calories of maltodextrin during 6 conditioning sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rated Liking
Time Frame: On the first day of enrollment to the post-test session approximately 1-2 weeks later
Participants will rate liking of flavors that will be paired with conditioned stimulus (CS) + and CS- drinks on a labeled hedonic scale during an enrollment session. In a post-test session, after all conditioning sessions have occurred, participants will rate liking of flavors that were previously paired with CS+ and CS- drinks.
On the first day of enrollment to the post-test session approximately 1-2 weeks later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rated Wanting
Time Frame: On the first day of enrollment to the post-test session approximately 1-2 weeks later
Participants will rate wanting of flavors that will be paired with conditioned stimulus (CS) + and CS- drinks on a visual analog scale during an enrollment session. In a post-test session, after all conditioning sessions have occurred, participants will rate wanting of flavors that were previously paired with CS+ and CS- drinks.
On the first day of enrollment to the post-test session approximately 1-2 weeks later
Proportion Correct on a Probabilistic Learning Task
Time Frame: Approximately 30-45 minutes during the enrollment/screening session at the start of the study
Participants will complete a probabilistic learning task in which they choose between abstract stimuli and observe probabilistic outcomes with the goal of maximizing accuracy. The proportion of trials in which the objectively optimal choice has been selected will be computed as the proportion correct.
Approximately 30-45 minutes during the enrollment/screening session at the start of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Polytechnic Institute and State University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

May 28, 2026

First Submitted That Met QC Criteria

June 5, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-058
  • K01DK142002 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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