AdiposityNo acronymNCT07638059
The Influence of Obesity and Insulin Sensitivity on Reward Processing and Decision Making
A study testing Beverage: Conditioned Stimulus - and Beverage: Conditioned Stimulus + in people with Adiposity and Insulin Sensitivity/Resistance, run by Virginia Polytechnic Institute and State University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Adiposity, Insulin Sensitivity/Resistance, Decision-Making
- What is being tested?
- Beverage: Conditioned Stimulus - and Beverage: Conditioned Stimulus +
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Jul 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
About this study
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.
- Being tested
- Beverage: Conditioned Stimulus -, Beverage: Conditioned Stimulus +
- Keywords
- flavor nutrient learning, insulin sensitivity, adiposity, decision-making, probabilistic learning
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage: Conditioned Stimulus -Other
Participants will consume flavored beverage solutions sweetened with sucralose during 6 conditioning sessions.
Beverage: Conditioned Stimulus +Other
Participants will consume flavored beverage solutions sweetened with sucralose and containing 110 calories of maltodextrin during 6 conditioning sessions.
| Study group | Role | What they receive |
|---|---|---|
| Conditioned Stimulus- First, Then Conditioned Stimulus + | Experimental | 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. Receives: Other: Beverage: Conditioned Stimulus -; Other: Beverage: Conditioned Stimulus + |
| Conditioned Stimulus + First, Then Conditioned Stimulus - | Experimental | 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. Receives: Other: Beverage: Conditioned Stimulus -; Other: Beverage: Conditioned Stimulus + |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rated Liking
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.
Measured: On the first day of enrollment to the post-test session approximately 1-2 weeks later
Secondary outcomes (2)
Rated Wanting
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.
Measured: On the first day of enrollment to the post-test session approximately 1-2 weeks later
Proportion Correct on a Probabilistic Learning Task
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.
Measured: Approximately 30-45 minutes during the enrollment/screening session at the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdiposityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Elizabeth Baugh, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638059
- Sponsor's protocol ID
- 26-058
- Other IDs
- K01DK142002
- Acronym
- No acronym
- Status last verified
- Aug 2026
- First submitted
- 28 May 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No