Testing the Abuse Liability of Hyper-palatable Foods
11 de septiembre de 2026 actualizado por: University of Kansas
Bet You Can't Eat Just One: Testing the Abuse Liability of Hyper-palatable Foods
The study will conduct a laboratory study designed to evaluate the rewarding and addictive properties of hyper-palatable foods (HPF), using potato chips as the food stimulus/sample HPF.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
A within-subjects, double-blind, randomized crossover design will be used to test the abuse liability of a commonly consumed hyper-palatable food (HPF; potato chips) in controlled laboratory conditions, compared to a negative (non-HPF) control and modified doses (Aim 1).
In alignment with FDA requirements, the study will randomize participants to complete four study sessions in one of four mixed orders to counterbalance the ordering of food stimuli across participants.
One food will be assessed per session.
Abuse liability tests will consist of an acute dose effects comparison to evaluate differences in acute rewarding effects, and a test of HPF reinforcing effects via a self-administration task and behavioral economic food purchase task.
Participants will be community members who report high dietary intake of potato chips (HPF stimulus in the study), and do not have substance use disorder or eating disorders, which may present confounds.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
168
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Tera Fazzino, Doctorate
- Número de teléfono: 785-864-0062
- Correo electrónico: tfazzino@ku.edu
Copia de seguridad de contactos de estudio
- Nombre: Cash Petree, B.S.
- Número de teléfono: 615-999-5677
- Correo electrónico: cashpetree@ku.edu
Ubicaciones de estudio
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Kansas
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Lawrence, Kansas, Estados Unidos, 66049
- Reclutamiento
- Dole Human Development Center
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Contacto:
- Tera Fazzino, Doctorate
- Número de teléfono: 785-864-0062
- Correo electrónico: tfazzino@ku.edu
-
-
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
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Adults 18+ years old
- High dietary intake of regular potato chips (HPF stimulus in the study), identified as >=3 times per week via a standard dietary history questionnaire
- Like potato chips, the study-provided food (rating of >6 out of 10 on visual analogue scale) and willing to consume them in the lab.
Exclusion Criteria:
- Currently prescribed medications for weight loss (e.g., Ozempic), attention deficit hyperactivity disorder, substance use disorder, or binge eating disorder
- Substance use disorder diagnosis in the past year (self-reported) or substantial consequences from substance use in the past year (score on Drug Abuse Screening Test-10 of 6 or higher)
- Eating disorder diagnosis in the past year
- Bariatric surgery in the past year
- Dietary allergies or restrictions to gluten
- Dietary allergies or restrictions to root vegetables
- Currently participating in a weight management treatment program or engaging in dietary modification to induce weight loss
- Trying to cut down on HPF intake
- Diagnosed smell or taste dysfunction
- Currently pregnant
- Diagnosed cognitive impairment (self-reported)
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Sequence 1: Full Dose HPF → Modified Dose- No Fat → Modified Dose No Sodium → Negative Control
Participants receive Full Dose HPF chip at Visit 1, Modified Dose- No Fat chip at Visit 2, Modified Dose- No Sodium chip at Visit 3, and Negative Control chip at Visit 4.
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This food stimulus is a regular, fried potato chip (with no modifications), considered the full dose hyper-palatable food stimulus. The nutrient characteristics are as followed (per 7 grams): 40kcal calories, 2.5g fat, 35mg sodium, 3.8g carbs.
The food stimulus is a baked/"air fried" potato chip with sodium.
Thus, the stimulus will have almost no fat.
The nutrient characteristics are as followed (per 7 grams): 34kcal calories, 0.9g fat, 37mg sodium, 4.0g carbs.
The food stimulus will be a fried potato chip, unsalted.
The nutrient characteristics are as followed (per 7 grams): 38kcal calories, 2.5g fat, 0.6mg sodium, 3.8g carbs
The food stimulus is a baked/"air fried" Jicama root vegetable chip which will serve as the negative control with no sodium, fat, and lower carbohydrates.
The nutrient characteristics are as followed (per 7 grams): 20kcal calories, 0g fat, 0.1g sodium, 0.7g carbs.
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Otro: Sequence 2: Modified Dose- No Fat → Modified Dose- No Sodium → Negative Control → Full Dose HPF
Participants receive Modified Dose- No Fat chip at Visit 1, Modified Dose- No Sodium chip at Visit 2, Negative Control chip at Visit 3, and Full Dose HPF chip at Visit 4.
|
This food stimulus is a regular, fried potato chip (with no modifications), considered the full dose hyper-palatable food stimulus. The nutrient characteristics are as followed (per 7 grams): 40kcal calories, 2.5g fat, 35mg sodium, 3.8g carbs.
The food stimulus is a baked/"air fried" potato chip with sodium.
Thus, the stimulus will have almost no fat.
The nutrient characteristics are as followed (per 7 grams): 34kcal calories, 0.9g fat, 37mg sodium, 4.0g carbs.
The food stimulus will be a fried potato chip, unsalted.
The nutrient characteristics are as followed (per 7 grams): 38kcal calories, 2.5g fat, 0.6mg sodium, 3.8g carbs
The food stimulus is a baked/"air fried" Jicama root vegetable chip which will serve as the negative control with no sodium, fat, and lower carbohydrates.
The nutrient characteristics are as followed (per 7 grams): 20kcal calories, 0g fat, 0.1g sodium, 0.7g carbs.
|
|
Otro: Sequence 3: Modified Dose- No Sodium → Negative Control → Full Dose HPF → Modified Dose- No Fat
Participants receive Modified No Salt chip at Visit 1, Negative Control chip at Visit 2, Full Dose HPF chip at Visit 3, and Modified No Fat chip at Visit 4.
|
This food stimulus is a regular, fried potato chip (with no modifications), considered the full dose hyper-palatable food stimulus. The nutrient characteristics are as followed (per 7 grams): 40kcal calories, 2.5g fat, 35mg sodium, 3.8g carbs.
The food stimulus is a baked/"air fried" potato chip with sodium.
Thus, the stimulus will have almost no fat.
The nutrient characteristics are as followed (per 7 grams): 34kcal calories, 0.9g fat, 37mg sodium, 4.0g carbs.
The food stimulus will be a fried potato chip, unsalted.
The nutrient characteristics are as followed (per 7 grams): 38kcal calories, 2.5g fat, 0.6mg sodium, 3.8g carbs
The food stimulus is a baked/"air fried" Jicama root vegetable chip which will serve as the negative control with no sodium, fat, and lower carbohydrates.
The nutrient characteristics are as followed (per 7 grams): 20kcal calories, 0g fat, 0.1g sodium, 0.7g carbs.
|
|
Otro: Sequence 4: Negative Control → Full Dose HPF → Modified Dose- No Fat → Modified Dose- No Sodium
Participants receive Negative Control chip at Visit 1, Full Dose HPF chip at Visit 2, Modified No Fat chip at Visit 3, and Modified No Salt chip at Visit 4.
|
This food stimulus is a regular, fried potato chip (with no modifications), considered the full dose hyper-palatable food stimulus. The nutrient characteristics are as followed (per 7 grams): 40kcal calories, 2.5g fat, 35mg sodium, 3.8g carbs.
The food stimulus is a baked/"air fried" potato chip with sodium.
Thus, the stimulus will have almost no fat.
The nutrient characteristics are as followed (per 7 grams): 34kcal calories, 0.9g fat, 37mg sodium, 4.0g carbs.
The food stimulus will be a fried potato chip, unsalted.
The nutrient characteristics are as followed (per 7 grams): 38kcal calories, 2.5g fat, 0.6mg sodium, 3.8g carbs
The food stimulus is a baked/"air fried" Jicama root vegetable chip which will serve as the negative control with no sodium, fat, and lower carbohydrates.
The nutrient characteristics are as followed (per 7 grams): 20kcal calories, 0g fat, 0.1g sodium, 0.7g carbs.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Subjective effect measure: food stimulus liking
Periodo de tiempo: Baseline, at each visit
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During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how much they like the food stimulus they tasted
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Baseline, at each visit
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Subjective effect measure: food stimulus wanting/desire
Periodo de tiempo: Baseline, at each visit
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During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how much they desire more of the food stimulus they tasted.
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Baseline, at each visit
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Subjective effect measure: food stimulus craving
Periodo de tiempo: Baseline, at each visit
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During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how much they crave the food stimulus they tasted.
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Baseline, at each visit
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Subjective effect measure: food stimulus likelihood to use again
Periodo de tiempo: Baseline, at each visit
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During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how likely they would be to use the food stimulus they tasted again in the future.
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Baseline, at each visit
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Demand elasticity value of the food stimulus
Periodo de tiempo: Baseline, at each visit
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Primary outcome of the Food Purchase Task, which characterizes sensitivity to the cost of a food stimulus with escalations in price.
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Baseline, at each visit
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Breakpoint value in self-administration task
Periodo de tiempo: Baseline, at each visit
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Highest schedule completed to earn a food stimulus reward during the self-administration task
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Baseline, at each visit
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Subjective effect measure: food stimulus flavor intensity
Periodo de tiempo: Baseline, at each visit
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During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how intense the flavor of the food stimulus is that they tasted.
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Baseline, at each visit
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Subjective effect measure: food stimulus relaxation
Periodo de tiempo: Baseline, at each visit
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During the acute dose effects comparison, participants will rate on a visual analogue scale (0-100) how relaxed they felt from the food stimulus they tasted.
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Baseline, at each visit
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el 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 (Actual)
8 de septiembre de 2026
Finalización primaria (Estimado)
1 de noviembre de 2030
Finalización del estudio (Estimado)
30 de enero de 2031
Fechas de registro del estudio
Enviado por primera vez
22 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de agosto de 2026
Publicado por primera vez (Actual)
20 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de septiembre de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- STUDY00151790
- 1R01DA062585-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Participant-level data will be shared with National Addiction & Health Data Archive Program (NAHDAP).
Marco de tiempo para compartir IPD
When the main outcomes are published (anticipated 2031)
Criterios de acceso compartido de IPD
Study data will be housed at NIH's National Data Archive.
Other study details will be posted on the study's clinicaltrials.gov
site.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
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. .