NCT07638059

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
37mo left

Started Jul 2026

Typical duration for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

May 28, 2026

Last Update Submit

June 5, 2026

Conditions

Keywords

flavor nutrient learninginsulin sensitivityadipositydecision-makingprobabilistic learning

Outcome Measures

Primary Outcomes (1)

  • 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.

    On the first day of enrollment to the post-test session approximately 1-2 weeks later

Secondary Outcomes (2)

  • Rated Wanting

    On the first day of enrollment to the post-test session approximately 1-2 weeks later

  • Proportion Correct on a Probabilistic Learning Task

    Approximately 30-45 minutes during the enrollment/screening session at the start of the study

Study Arms (2)

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.

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.

Other: Beverage: Conditioned Stimulus -Other: Beverage: Conditioned Stimulus +

Interventions

Participants will consume flavored beverage solutions sweetened with sucralose and containing 110 calories of maltodextrin during 6 conditioning sessions.

Conditioned Stimulus + First, Then Conditioned Stimulus -Conditioned Stimulus- First, Then Conditioned Stimulus +

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • BMI \< 18.5 or \> 40 kg/m2
  • Hemoglobin A1c \> 6.4%
  • Fasting blood glucose \> 126 mg/dL
  • 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 allergy to ingredient used in the study drinks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 10, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

June 10, 2026

Record last verified: 2026-06