Does Increased Egg Consumption Have Cognitive and Neural Benefits in Food Insecure, At-risk Adolescents?
9 de noviembre de 2021 actualizado por: Martin Binks, Texas Tech University
Quality nutrient intake is essential for proper development and well-being of children in all aspects of health, including cognitive development.
Eggs are of particular interest based on potential cognitive and neurological benefits due in part to significant concentrations of choline and lutein.
While overall, choline and lutein have received considerable attention in the literature in relation to cognition and brain function, most studies involving intake in young adults have had short intervention periods ranging from 90 minutes to 3 days.
Food insecurity has been associated with decreased academic performance.
Given that populations with food insecurity have limited resources to direct towards nutrition, identifying how a widely available, highly versatile and largely affordable source of nutrients (i.e.
eggs) may have favorable impacts on cognitive function and brain function will be valuable in informing public health recommendations in this at-risk population.
As such the investigators will examine whether an increased egg consumption dietary prescription can have positive effects on functional activity (i.e.
fMRI) during an Eriksen-Flanker task, anatomical changes in the brain (i.e.
DTI, MRI), and cognitive abilities as measured by the Stop Signal Reaction Time task, Operation Span task, Raven's Progressive Matrices and the Boston Naming Task.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
18
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
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Texas
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Lubbock, Texas, Estados Unidos, 79410
- Nutrition & Metabolic Health Initiative
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Lubbock, Texas, Estados Unidos, 79409
- Texas Tech Neuroimaging Institute
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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
13 años a 19 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age: 13-19 years.
- Household has food security status of low or very low as designated by scoring 2-6 raw score using the U.S. Household Food Security Survey Module: Six-Item Short Form.
Exclusion Criteria:
- Participants unable or unwilling to provide informed consent.
- Participants with motor, visual or hearing impairment.
- Participants with current severe psychiatric illnesses (e.g. psychosis, schizophrenia, bipolar disorders, depression)
- Participants with history of psychiatric hospitalization.
- Participants with habitual egg consumption (past 3 months) of 4 eggs per week or more
- Unable or unwilling to consume required study meals for any reason (e.g. dietary restrictions, allergies, or aversions to any of the food items used in the study).
- History of liver or kidney disease, cardiovascular disease, hematologic disease, metabolic disease, Epilepsy (or other seizure disorder) or malignant tumor
- Currently taking (or have taken in the past 4 weeks) any anti-anxiolytic, anti-epileptic, or anti-depression medications
- Currently taking (or have taken in the past 4 weeks) any proton pump inhibitor medications
- History of any cognitive disorder, medical and/or psychological conditions and/or medications affecting cognition
Participants with contraindications for MRI scanning.
- aneurism clips
- any implanted medical devices (pacemaker, neurostimulator)
- known pregnancy
- shrapnel in body or any injury to eye involving metal
- any ferrous metal in body
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Typical Diet (TD)
Participants will be instructed to continue habitual dietary intake.
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Subjects will be instructed to maintain their current dietary patterns.
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Experimental: Increased Egg Consumption (IE)
Participants will be prescribed an additional 2 eggs per day to their diet.
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Subjects will be instructed to use a weekly food purchase supplement for inclusion of 2 additional eggs per day to be added to subject's typical daily diet.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Comparison of functional activity during Eriksen-Flanker Task
Periodo de tiempo: Baseline (pre-intervention) and 12 weeks (post-intervention)
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Changes in regional brain activation during an fMRI scan.
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Baseline (pre-intervention) and 12 weeks (post-intervention)
|
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Comparison of grey matter anatomical change
Periodo de tiempo: Baseline (pre-intervention) and 12 weeks (post-intervention)
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Grey density as measured by MRI
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Baseline (pre-intervention) and 12 weeks (post-intervention)
|
|
Comparison of white matter connectivity change
Periodo de tiempo: Baseline (pre-intervention) and 12 weeks (post-intervention)
|
White matter connectivity as measured by diffusion tensor imaging
|
Baseline (pre-intervention) and 12 weeks (post-intervention)
|
|
Comparison of cognitive battery performance change
Periodo de tiempo: Baseline (pre-intervention) and 12 weeks (post-intervention)
|
Cognitive performance as measured by stop signal reaction time task
|
Baseline (pre-intervention) and 12 weeks (post-intervention)
|
|
Comparison of cognitive battery performance change
Periodo de tiempo: Baseline (pre-intervention) and 12 weeks (post-intervention)
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Cognitive performance as measured by operation span task
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Baseline (pre-intervention) and 12 weeks (post-intervention)
|
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Comparison of cognitive battery performance change
Periodo de tiempo: Baseline (pre-intervention) and 12 weeks (post-intervention)
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Cognitive performance as measured by Raven's Progressive Matrices
|
Baseline (pre-intervention) and 12 weeks (post-intervention)
|
|
Comparison of cognitive battery performance change
Periodo de tiempo: Baseline (pre-intervention) and 12 weeks (post-intervention)
|
Cognitive performance as measured by Boston Naming Task
|
Baseline (pre-intervention) and 12 weeks (post-intervention)
|
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Comparison of Eriksen-Flanker Task performance change
Periodo de tiempo: Baseline (pre-intervention) and 12 weeks (post-intervention)
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Eriksen-Flanker task performance compared using the drift diffusion model
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Baseline (pre-intervention) and 12 weeks (post-intervention)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Martin Binks, PhD, Texas Tech University- Department of Nutritional Sciences
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)
1 de mayo de 2019
Finalización primaria (Actual)
1 de marzo de 2021
Finalización del estudio (Actual)
1 de marzo de 2021
Fechas de registro del estudio
Enviado por primera vez
10 de mayo de 2019
Primero enviado que cumplió con los criterios de control de calidad
14 de mayo de 2019
Publicado por primera vez (Actual)
16 de mayo de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de noviembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
9 de noviembre de 2021
Última verificación
1 de noviembre de 2021
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- TTUIRB2019-160
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. .