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A Pilot Study: Snacking, Willpower and Glucose Availability (SWG)

4 de febrero de 2016 actualizado por: University of Colorado, Denver
To compare the effects of ingesting 100, 50 and 10 calories of glucose as compared to a non-calorie placebo (0 calorie beverage) on self-control over resisting snack foods. To test whether there is a threshold of glucose that will result in improved ease of resistance to problem foods (tested by comparing three different levels of glucose).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Ingestion of 100 calories of glucose during individually pre-determined times of waning dietary self-control will result in improved ease of resistance to problem foods when compared to ingestion of lower calories of glucose or placebo (0 calorie beverage)

Tipo de estudio

Intervencionista

Inscripción (Actual)

37

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.

Ubicaciones de estudio

  • Estados Unidos
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Anschutz Health and Wellness Center

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

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  1. Females ages 18 - 65 years.
  2. Self-identify as regular snackers, with a specific problem food, who have trouble with over-consuming this snack food.
  3. Have intentionally lost weight in the last year and are seeking to maintain that weight loss or have unintentionally gained weight in the last year and are concerned about it.
  4. Generally healthy.

Exclusion Criteria:

  1. Pregnant or trying to become pregnant.
  2. Diagnosis of type 1 or type 2 diabetes
  3. Not willing or able to follow study guidelines (ie: consuming the study beverage daily for four weeks, or completing daily compliance logs)
  4. Current smoker (or has stopped smoking within the last 6 months)
  5. Taking medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over the counter weight loss agents, etc).
  6. Current or history of eating disorder (anorexia, bulimia, or diagnosed binge eating disorder)
  7. Current alcohol or drug abuse or dependence
  8. Any medical condition for which daily snacking of such problem foods would be inadvisable (i.e.: a subject with hypertension advised to avoid sodium).

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

  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Sequence 1 (D-B-A-C)
100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.
Suplemento dietético: Sequence 1
100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.
Comparador activo: Sequence 2 (A-D-C-B)
Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.
Suplemento dietético: Sequence 2
Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.
Comparador activo: Sequence 3 (C-A-B-D)
50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.
Suplemento dietético: Sequence 3
50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.
Comparador activo: Sequence 4 (B-C-D-A)
10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.
Suplemento dietético: Sequence 4
10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Responses to the Control of Eating Questionnaire
Periodo de tiempo: 4 weeks

Study participant will complete Eating Questionnaire at baseline and the next 4 visits. Each questionnaire item used a likert scale (with ratings from 1 - 10). All question pertain to the last 7 days. Questionnaire items #9 asked "what one food makes it most difficult for you to control eating?" and question #10 asked " What time are you particularly vulnerable to this one food." Higher ratings are consistent with a more significant or more frequent outcome.

Note that values in the data table below are absolute scores at each week that the subject consumed the noted treatment dose. As subjects were randomized to different sequence orders to receive the study beverages, subjects consumed any given treatment dose at different weeks (depending on their randomized sequence order).
4 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control.
Periodo de tiempo: 4 weeks

Study participant will record if the problem snack was consumed each day within the 3 hour period following consumption of the study beverage.

Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at the identified time of waning dietary self-control. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at the identified time of waning dietary self-control/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.
4 weeks
Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week.
Periodo de tiempo: 4 weeks
Study participant will record daily the time problem snack food was consumed. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at any time of day. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at any time of day/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.
4 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Colorado, Denver

Colaboradores

Johnson & Johnson

Investigadores

  • Investigador principal: James O Hill, PhD, Anschutz Health and Wellness Center

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.

Publicaciones Generales

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

1 de octubre de 2014

Finalización primaria (Actual)

1 de enero de 2015

Finalización del estudio (Actual)

1 de febrero de 2015

Fechas de registro del estudio

Enviado por primera vez

2 de octubre de 2014

Primero enviado que cumplió con los criterios de control de calidad

6 de octubre de 2014

Publicado por primera vez (Estimar)

7 de octubre de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

4 de marzo de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

4 de febrero de 2016

Última verificación

1 de febrero de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 14-1485

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. .

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