The Influence of Obesity and Insulin Sensitivity on Reward Processing and Decision Making (No acronym)
24 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
50
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rated Liking
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rated Wanting
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de julio de 2029
Finalización del estudio (Estimado)
1 de julio de 2029
Fechas de registro del estudio
Enviado por primera vez
28 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de junio de 2026
Publicado por primera vez (Actual)
10 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-058
- K01DK142002 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .