- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01490034
Effects of Learning and Food Form on Intake in Humans
Due to the rising incidence of obesity, much emphasis has been placed on identifying mechanisms of increased energy intake. At this point, the mechanisms responsible for the recent increase in obesity prevalence have not been thoroughly examined. Pre-ingestive influences, such as cognitive factors, may play a larger role in creating an energy surplus than previously thought. Expectations about the satiating effect of a food may override the post-ingestive influences in dictating further consumption. In addition, obese individuals may exhibit a decreased compensatory response to foods as compared to lean individuals.
Understanding the effects of energy content, food form, and learning on satiation, satiety, and energy intake will allow for a greater understanding of the mechanisms of energy imbalance as a whole. Food choice is dictated by sensory properties and post-ingestive effects. By utilizing foods with similar sensory properties, the acquired knowledge derived from ingesting these foods can be monitored by analyzing subsequent intake at the same meal and at subsequent eating occurrences. It is hypothesized that the liquid food form will elicit weaker dietary compensation; that is, energy intake at other eating events will not be adjusted to compensate for that food. In addition, it is posited that the lower energy food will cause lower compensation postprandially. By having participants consume the same test food daily over a two week learning period, it is thought that they will show improved dietary compensation when the initial testing is repeated due to learned associations between food properties and metabolism.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Indiana
-
W. Lafayette, Indiana, Estados Unidos, 47907
- Purdue Univeristy
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Weight stable (<3 kg weight change within last 3 months)
- Constant habitual activity patterns (no deviation > 1x/wk at 30 min/session within last 3 months)
- Constant habitual diet patterns within last 3 months
- Willingness to eat a chocolate-flavored snack at test sessions and two week training period
- No allergies to any test foods
- Not planning to change use of medications known to influence appetite or metabolism
- Not diabetic
- No history of GI pathology
- Non-smoker for one year or more
Exclusion Criteria:
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Energy dense beverage
Metabolic effects of consuming energy dense beverages before and after regular consumption
|
Consumption of energy dense beverages for 2 weeks and monitoring physiological responses
|
|
Experimental: Energy dense solid food form
Metabolic effects of consuming energy dense solid foods before and after regular exposure.
|
Effects of consuming energy dense solid food for two weeks on physiological responses
|
|
Experimental: Eenergy dilute beverages
Metabolic effects of consumption of energy dilute beverages on a regular basis.
|
Effects of consuming energy dilute beverages for two weeks on physiological responses.
|
|
Experimental: Energy dilute solid food form
Metabolic effects of consuming energy dilute sold foods before and after regular exposure.
|
Effects of consuming energy dilute solid food for two weeks on physiological responses
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
energy intake
Periodo de tiempo: 12 weeks
|
Energy consumed over 12 weeks of intervention.
|
12 weeks
|
|
dietary compensation
Periodo de tiempo: 12 weeks
|
spontaneous dietary adjustment in response to intervention
|
12 weeks
|
|
appetite
Periodo de tiempo: 12 weeks
|
Effects of intervention on appetitive sensation such as hunger and fullness
|
12 weeks
|
|
effects of learning on energy intake
Periodo de tiempo: 12 weeks
|
The effects of learning based on exposure to products that are high or low in energy and liquid or solid
|
12 weeks
|
|
Effects of food form on energy intake
Periodo de tiempo: 12 weeks
|
The effects of food form on energy intake before and after chronic exposure to foods varying in food form and energy density
|
12 weeks
|
|
Effects of BMI on sensory learning
Periodo de tiempo: 12 weeks
|
The effects of BMI on appetite, energy intake and dietary compensation
|
12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Effects of personality traits on appetite, energy intake and compensation
Periodo de tiempo: 12 weeks
|
Effects of personality traits related to feeding on appetite, energy intake and compensation following exposure to foods of different physical form, energy density and before and after learning.
|
12 weeks
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01DK079913-3
- R01DK079913 (Subvención/contrato del NIH de EE. UU.)
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. .