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Not yet recruiting NCT07638059

The Influence of Obesity and Insulin Sensitivity on Reward Processing and Decision Making

No phase Interventional Adiposity Insulin Sensitivity/Resistance Decision-Making Reward Learning

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Beverage: Conditioned Stimulus -, Beverage: Conditioned Stimulus +.
Who it may be relevant to
Registry conditions: Adiposity, Insulin Sensitivity/Resistance, Decision-Making, Reward Learning. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Rated Liking [Time frame: On the first day of enrollment to the post-test session approximately 1-2 weeks later]
Secondary outcome measures (2)
  • Rated Wanting [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07638059 · 26-058 · K01DK142002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗