The Benefits of Consuming Hummus as an Afternoon Snack
30 de abril de 2019 actualizado por: Heather Leidy, Purdue University
The Benefits of Consuming Hummus as an Afternoon Snack on Appetite Control, Daily Food Intake, and Diet Quality in Adults
The investigators propose a randomized snack study in normal to overweight adults that will test whether the consumption of different afternoon snacks will have different effects on appetite, mood, blood sugar control, and food intake.
Aim 1: To examine whether the addition of hummus as part of an afternoon snack will improve diet quality, particularly through assessments of daily:
- Vegetable consumption
- Snacking behavior
- Energy intake
- Food choices
Aim 2: To examine whether the addition of hummus as part of an afternoon snack will improve appetite control and satiety including assessments of:
- Appetite Control (hunger, desire to eat, prospective food consumption)
- Cravings (sweet, salty, savory)
- Satiety (fullness)
- Eating initiation
Aim 3: To examine whether the addition of hummus as part of an afternoon snack will improve free-living glycemic control.
Aim 4: To explore whether the addition of hummus as part of an afternoon snack will improve mood/energy states
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Experimental Design: For 6 consecutive days/treatment, the participants will consume either hummus and pretzels, granola bars, or no snack between 2-4 pm and refrain from eating anything else during this time.
On day 7, the participants will consume a standard breakfast, at home, and will come in to the investigator's facility 1 h prior to their habitual lunch time.
The participants will be placed in a comfortable room, void of all time cues and a standardized lunch will be consumed.
At 3 h after lunch, the participants will complete baseline appetite, satiety, and mood questionnaires.
The respective snack will be given to the participants, and they will have 20 minutes to eat the snack.
Snack palatability will also be assessed.
The participants will continue to complete the previous questionnaires until they voluntarily choose to eat (again).
At 3 h after snack, they will be presented with ad libitum dinner and evening snacks.
They will be permitted to eat as much or as little as they would like to eat over the remainder of the day.
In addition, from day 3 to day 8 of the testing week, continuous glucose monitoring will be completed to assess glucose control.
Tipo de estudio
Intervencionista
Inscripción (Actual)
33
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
-
-
Indiana
-
West Lafayette, Indiana, Estados Unidos, 47907
- Purdue University
-
-
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 50 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- normal to overweight (BMI: 18-32 kg/m2)
- no metabolic, psychological, or neurological diseases/conditions not currently or previously on a weight loss or other special diet (in the past 6 months)
- non-smoking
- not been clinically diagnosed with an eating disorder
- habitually eat an afternoon snack between 2:00-4:00 pm
- no food allergies related to the study snacks
- rates the overall liking of hummus higher than "Neither Like nor Dislike" on the screening palatability questionnaire.
Exclusion Criteria:
- Clinically diagnosed with an eating disorder
- Metabolic, hormonal, and/or neural conditions/diseases that influence metabolism or appetite
- Currently or previously on a weight loss or other special diet (in the past 6 months)
- Gained/lost >10 lb. over the past 6 months
- Taking medication that would directly influence appetite (weight-loss drugs or antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months)
- Not willing or able to complete all study testing procedures
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Snack
The study participants will be provided with a snack to consume every day of the week.
The energy content of the snacks will be standardized to ~240 kcal.
The snacks will have different levels of protein, fat, carbohydrates, sugar, and fiber.
|
Hummus and Pretzels- The study participants will be provided with a hummus and pretzels snack to consume every day for a week. The energy content of the hummus and pretzels will be ~240 kcal. The hummus and pretzels contain 6 g protein, 27 g carbohydrates, 0 g sugar, 4 g fiber, and 12 g fat. Granola Bars- The study participants will be provided with two granola bars to consume every day for a week. The energy content of the two granola bars will be ~240 kcal. The two granola bars contain 4 g protein, 38 g carbohydrates, 16 g sugar, 2 g fiber, and 9 g fat. |
|
Comparador de placebos: No Snack
The study participants will not be provided with any snack and will be told to consume nothing from 2-4pm for a week.
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The study participants will not be provided with any snack and will be told to consume nothing from 2-4pm for a week.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Perceived Hunger
Periodo de tiempo: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived hunger will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
|
Perceived Fullness
Periodo de tiempo: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived fullness will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
|
Perceived Desire to Eat
Periodo de tiempo: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived desire to eat will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
|
Perceived Prospective Food Consumption
Periodo de tiempo: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing how much food could be consumed will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Perceived Sweet
Periodo de tiempo: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived sweet cravings will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
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Perceived Salty
Periodo de tiempo: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived salty cravings will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
|
Perceived Savory
Periodo de tiempo: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived savory cravings will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
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Perceived Sleepiness
Periodo de tiempo: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived sleepiness will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
|
Perceived Energy
Periodo de tiempo: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived energy state will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
|
Perceived Alertness
Periodo de tiempo: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived alertness will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
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Ad libitum Snack Pack-out
Periodo de tiempo: 3 testing days
|
Free-living energy intake will be assessed on the in-clinic testing day of each treatment.
When the participant leaves the testing facility, the participant will be provided with an excess of snacks to consume, ad libitum, throughout the remainder of the day.
The quantity of food provided will be ~50% more than their estimated, weight-maintaining energy intake.
All food items will be initially weighed and recorded.
The participants will be instructed to return all uneaten foods as well as all wrappers and containers from consumed food.
Any partially eaten, returned items will be weighed accordingly.
The daily energy content will be assessed from these pack-outs.
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3 testing days
|
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Glucose Excursions Change
Periodo de tiempo: 6 days for each treatment
|
Free-living, glucose measures will be performed for 7 consecutive days using Continuous Glucose Monitoring Device.
The participants will report to our facility during one afternoon for insertion.
A small area on the participant's abdomen will be cleaned and the tiny glucose sensor will be inserted just under the skin and held in place with Tegederm.
The sensor measures glucose every 10sec and records an average glucose value every 5min for up to 144h.Calibration is performed by 4 finger sticks/d with a glucose analyzer.
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6 days for each treatment
|
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Perceived Snack Palatability
Periodo de tiempo: 2 testing days that include snacks
|
A questionnaires assessing how much the snack is liked will be completed at specific times throughout the 4-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
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2 testing days that include snacks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Heather J Leidy, PhD, Purdue University
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 junio de 2018
Finalización primaria (Actual)
20 de diciembre de 2018
Finalización del estudio (Actual)
20 de diciembre de 2018
Fechas de registro del estudio
Enviado por primera vez
30 de junio de 2018
Primero enviado que cumplió con los criterios de control de calidad
11 de julio de 2018
Publicado por primera vez (Actual)
23 de julio de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de mayo de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
30 de abril de 2019
Última verificación
1 de abril de 2019
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 1804020480
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. .