The Influence of Obesity and Insulin Sensitivity on Reward Processing and Decision Making (No acronym)
24. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Participants will consume flavored beverage solutions sweetened with sucralose during 6 conditioning sessions.
Participants will consume flavored beverage solutions sweetened with sucralose and containing 110 calories of maltodextrin during 6 conditioning sessions.
|
|
Eksperimentell: 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.
|
Participants will consume flavored beverage solutions sweetened with sucralose during 6 conditioning sessions.
Participants will consume flavored beverage solutions sweetened with sucralose and containing 110 calories of maltodextrin during 6 conditioning sessions.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rated Liking
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rated Wanting
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. juli 2029
Studiet fullført (Antatt)
1. juli 2029
Datoer for studieregistrering
Først innsendt
28. mai 2026
Først innsendt som oppfylte QC-kriteriene
5. juni 2026
Først lagt ut (Faktiske)
10. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 26-058
- K01DK142002 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .