Effects of Avocado Intake on the Nutritional Status of Families
3 de abril de 2020 actualizado por: Matthew Allison, University of California, San Diego
Avocados are an excellent source of fiber, potassium, magnesium, and poly- and mono-unsaturated fats.
They can be a nutrient dense component of healthful dietary patterns and have the potential to improve the cardiovascular disease (CVD) risk profiles of families in the United States (US).
The proposed research plan will focus on the contribution of avocado intake to the reduction in CVD risk of US families, by examining the effects of avocado intake on the overall nutritional status of families.
Of particular interest is establishing these effects in ethnic populations such as Hispanics/Latinos.
On average, Hispanic/Latinos are at increased risk for metabolic diseases that predispose to CVD.
This 6-month cluster randomized trial in Hispanic/Latino Americans aims to accurately determine the impact of avocados on the overall dietary pattern of their families.
Future research will extend the results of the current trial to a larger sample of ethnically diverse families in order to evaluate whether sustained changes occur in nutritional, cardiovascular and metabolic health status.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Specific Aim 1: To determine how avocados are incorporated into the family's dietary pattern and impact selected measures of nutritional status:
- To determine if avocado intake substitutes for, or adds to, other sources of calories in the family diet.
- To determine if avocado intake helps reduce between-meal snacking of family members.
- To determine if avocados help families meet US Dietary Guidelines for recommended intake of: poly- and monounsaturated fats; vegetables; fiber; selected nutrients (vitamins C, D and E, Folate, Calcium, Magnesium, potassium, iron); lutein and other carotenoids.
Specific aim 2: To determine if increased avocado intake affects cardio-metabolic risk factors to include lipids, glucose, insulin, and HbA1c.
Tipo de estudio
Intervencionista
Inscripción (Actual)
72
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
-
-
California
-
Chula Vista, California, Estados Unidos, 91910
- South Bay Latino Research 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
5 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Be part of a family that consists of at least 3 individuals, but no more than 8, who reside in the same home
- Self-identify as Latino or Hispanic
- Be older than 5 years of age
Exclusion Criteria:
- Families with members who have clinically severe chronic diseases requiring specific diets (e.g. stage IV congestive heart failure, chronic kidney disease requiring dialysis)
- Those allergic to avocados
- Those with LATEX allergy
- Families who are already high consumers of avocados (i.e. more than 1 avocado per adult and more than ½ avocado per child per day);
- Those who are unwilling to eat avocados.
- Family members with nursing or pregnant females or females planning to become pregnant
- Family members under the age of 5 years will not be counted toward the number of family members who will be expected to participate in the intervention (i.e., adhere to healthy diet tips or consume avocados)
- Families intending to move, or which include family members intending to move, within the next 6 months
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 paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: High Intake Group
Throughout the entire study, this group will be provided with 14 avocados per week and will receive 12 bi-weekly home visits over a 6-month period during which they will receive specific brochures offering "diet tips".
This group will be given specific advice on avocado consumption.
Each month throughout the study, we will provide opportunities for families to visit the study kitchen at the SYHC to observe the staff preparing recipes with avocado, participate in preparing recipes, and taste recipes.
|
Families will receive 14 avocados on a weekly basis.
Diet tips will come from educational materials including culturally appropriate dietary and nutritional education materials, and personalized recommendations taken from http://www.choosemyplate.gov.
Recipe book with healthy recipe suggestions that include avocado.
|
|
Comparador activo: Low Intake Group
This group will receive 3 avocados per week, as well as 12 bi-weekly home visits over a 6-month period during which they will be provided with the same educational materials (i.e., "Diet Tips") as those assigned to the "High intake" group.
Participants in this group will be encouraged to improve the quality of their diets, but will not be given specific advice on avocado consumption.
However, each month throughout the study, we will provide opportunities for families to visit the study kitchen at the SYHC to observe the staff preparing recipes with avocado, participate in preparing recipes, and taste recipes.
|
Diet tips will come from educational materials including culturally appropriate dietary and nutritional education materials, and personalized recommendations taken from http://www.choosemyplate.gov.
Recipe book with healthy recipe suggestions that include avocado.
Families will receive 3 avocados on a weekly basis.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in family energy consumption at 3 and 6 months
Periodo de tiempo: 3 months and 6 months
|
3 months and 6 months
|
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Change in distribution of macro and micronutrient intake at 6 months
Periodo de tiempo: 3 months and 6 months
|
3 months and 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in cardio-metabolic risk factors by serum lipids at 6 months
Periodo de tiempo: 3 months and 6 months
|
3 months and 6 months
|
|
Change in cardio-metabolic risk factors by insulin at 6 months
Periodo de tiempo: 3 months and 6 months
|
3 months and 6 months
|
|
Change in cardio-metabolic risk factors by glucose at 6 months
Periodo de tiempo: 3 months and 6 months
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3 months and 6 months
|
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Change in cardio-metabolic risk factors by computation of homeostasis model assessment at 6 months
Periodo de tiempo: 3 months and 6 months
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3 months and 6 months
|
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Change in nutritional status by red blood cell fatty acid composition at 6 months
Periodo de tiempo: 3 months and 6 months
|
3 months and 6 months
|
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Change in nutritional status by red blood cell magnesium at 6 months
Periodo de tiempo: 3 months and 6 months
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3 months and 6 months
|
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Change in nutritional status by serum total and fractionated carotenoids at 6 months
Periodo de tiempo: 3 months and 6 months
|
3 months and 6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Matthew A Allison, MD, MPH, University of California, San Diego
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)
20 de abril de 2017
Finalización primaria (Actual)
8 de enero de 2019
Finalización del estudio (Actual)
8 de enero de 2019
Fechas de registro del estudio
Enviado por primera vez
2 de septiembre de 2016
Primero enviado que cumplió con los criterios de control de calidad
12 de septiembre de 2016
Publicado por primera vez (Estimar)
16 de septiembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de abril de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
3 de abril de 2020
Última verificación
1 de abril de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 160584
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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. .