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Cardioprotective Activities Of Whole Eggs On Vascular Endothelial Function In Prediabetic Adults

1 de mayo de 2019 actualizado por: Richard Bruno, Ohio State University
Cardiovascular disease (CVD) is largely a lifestyle-related condition that is the #1 killer of adults in the United States. Our work is aimed at understanding how short-term increases in blood sugar, like those that accompany eating a meal, affect blood vessel function and the risk of CVD. This research is aimed at understanding how meals composed of eggs affect short-term increases in blood sugar from eating, which are connected with increased risk of CVD. In particular, the investigators are trying to identify a specific meal composed of either whole eggs, egg yolks, or egg whites, that best reduces acute increases in blood sugar brought on by meals that consist of majority carbohydrate. At the same time, the investigators are trying to explore the protective affects that eggs may have on blood vessel function and the reduction of CVD risk.

Descripción general del estudio

Descripción detallada

Cardiovascular disease (CVD) is the leading cause of death in the United States [1]. The inability of your blood vessels to properly enlarge and shrink, known as vascular endothelial dysfunction (VED), is an early event leading to CVD and can be caused by postprandial hyperglycemia (PPH) [1] or short-term increases in blood sugar that occur after you have eaten. Although we do not know how this occurs, research shows that temporary increases in blood sugar impair the blood vessel's ability to properly enlarge and shrink. We also know that impaired vessel function is an early event leading to CVD and that research shows that short-term increases in blood sugar impair blood vessel function, even in healthy people [2].

Because high blood levels of cholesterol increase CVD risk, this has triggered flawed guidelines to restrict cholesterol in our diet [3], including limiting egg consumption. The misguided fear towards eating eggs has been routinely challenged by large-scale studies failing to associate eggs with heart disease risk [4-8]. Research shows that eggs improve the functioning of insulin to reduce blood sugar [9]. They also contain bioactive peptides that may attenuate oxidative stress [10-11]. This provides rationale for their study as a dietary strategy to reduce PPH and VED. Thus, the objective of this study is to define the potential benefits of eggs and its components (egg yolk and egg whites) on blood vessel health in adults with prediabetes.

Tipo de estudio

Intervencionista

Inscripción (Actual)

20

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

    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • The Ohio State 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

Géneros elegibles para el estudio

Masculino

Descripción

Inclusion Criteria:

  1. fasting glucose 100-125 mg/dL,
  2. non-dietary supplement user,
  3. no medications affecting vasodilation, inflammation, or energy metabolism,
  4. no CVD,
  5. nonsmokers,
  6. individuals having blood pressure <130/85 mmHg and total cholesterol <240 mg/dL.

Exclusion Criteria:

  1. unstable weight (±2 kg),
  2. vegetarian or egg allergy,
  3. alcohol intake >3 drinks/d or >10 drinks/wk), or
  4. ≥7 h/wk of aerobic activity.

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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Oral Glucose Tolerance Test
We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (100 g). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.
Ingestion of glucose (100g)
Experimental: Glucose with Whole Eggs
We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (75 g) with 1.5 whole eggs (cooked). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.
Ingestion of glucose (75g)
Ingestion of 1.5 whole eggs
Experimental: Glucose with Egg Whites
We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (75 g) with 7 egg whites (cooked). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.
Ingestion of glucose (75g)
Ingestion of 7 egg whites
Experimental: Glucose with Egg Yolks
We will perform fasting measurements of flow-mediated dilation (FMD) using ultrasound, and draw a blood sample, prior to administration of the test meal. Following these baseline measurements, participants will ingest glucose (75 g) with 2 egg yolks (cooked). FMD will be performed intermittently post-ingestion at 30, 60, 90, 120, 150, and 180 minutes. Blood samples will be collected at 0 min (immediately prior to eating) and at 30, 60, 90, 120, 150, and 180 minutes following the ingestion of the meal. After each blood sample is obtained, the catheter will be flushed with saline in order to prevent the formation of clots and to minimize the likelihood of having to insert a needle again. Subjects will remain supine in a comfortable position for the entire duration of the test.
Ingestion of glucose (75g)
Ingestion of 2 egg yolks

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Vascular Endothelial Function
Periodo de tiempo: Area under the curve of brachial artery FMD for 3 hours (0, 30, 60, 90, 120 min)
Flow mediated dilation (FMD) evaluated on the basis as change from baseline to calculate FMD area under the curve from 0-180 min, i.e. i.e. Area Under the Curve (AUC) of change from baseline in FMD from 0 min to 180 min (i.e., AUC (FMD 0 min- 0 min, FMD 30 min-0 min, FMD 60 min-0 min, etc)
Area under the curve of brachial artery FMD for 3 hours (0, 30, 60, 90, 120 min)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Glucose
Periodo de tiempo: Area under the curve for plasma glucose for 3 hours (0, 30, 60, 90, 120 min)
Glucose concentrations evaluated on the basis as change from baseline to calculate glucose area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in glucose from 0 min to 180 min (i.e., AUC (glucose 0 min- 0 min, glucose 30 min-0 min, glucose 60 min-0 min, etc)
Area under the curve for plasma glucose for 3 hours (0, 30, 60, 90, 120 min)
Oxidative Stress Biomarker (Malondialdehyde; MDA)
Periodo de tiempo: Area under curve of MDA for 3 hours (0, 30, 60, 90, 120, 150, 180 min)
MDA concentrations evaluated on the basis as change from baseline to calculate MDAarea under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in MDA from 0 min to 180 min (i.e., AUC (MDA 0 min- 0 min, MDA 30 min-0 min, MDA 60 min-0 min, etc)
Area under curve of MDA for 3 hours (0, 30, 60, 90, 120, 150, 180 min)
Insulin
Periodo de tiempo: Area under the curve for plasma insulin for 3 hours (0, 30, 60, 90, 120 min)
Insulin concentrations evaluated on the basis as change from baseline to calculate insulin area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in insulin from 0 min to 180 min (i.e., AUC (Insulin 0 min- 0 min, insulin 30 min-0 min, insulin 60 min-0 min, etc)
Area under the curve for plasma insulin for 3 hours (0, 30, 60, 90, 120 min)
Cholecystokinin (CCK)
Periodo de tiempo: Area under the curve for 3 hours (0, 30, 60, 90, 120 minutes)
CCK concentrations evaluated on the basis as change from baseline to calculate CCK area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in CCK from 0 min to 180 min (i.e., AUC (CCK 0 min- 0 min, CCK 30 min-0 min, CCK 60 min-0 min, etc)
Area under the curve for 3 hours (0, 30, 60, 90, 120 minutes)
Methylglyoxal (MGO)
Periodo de tiempo: Area under the curve for methylglyoxal for 3 hours (0, 30, 60, 90, 120 min)
MGO concentrations evaluated on the basis as change from baseline to calculate MGO area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in MGO from 0 min to 180 min (i.e., AUC (MGO 0 min- 0 min, MGO 30 min-0 min, MGO 60 min-0 min, etc)
Area under the curve for methylglyoxal for 3 hours (0, 30, 60, 90, 120 min)
8-isoprostaglandin-F2a
Periodo de tiempo: Area under the curve for 8-isoprostaglandin-F2a for 3 hours (0, 30, 60, 90, 120 min)
8-isoprostaglandin-F2a concentrations evaluated on the basis as change from baseline to calculate 8-isoprostaglandin-F2a area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in 8-isoprostaglandin-F2a from 0 min to 180 min (i.e., AUC (8-isoprostaglandin-F2a 0 min- 0 min, 8-isoprostaglandin-F2a 30 min-0 min, 8-isoprostaglandin-F2a 60 min-0 min, etc)
Area under the curve for 8-isoprostaglandin-F2a for 3 hours (0, 30, 60, 90, 120 min)
Arachidonic Acid (AA)
Periodo de tiempo: Area under the curve for arachidonic acid for 3 hours (0, 30, 60, 90, 120 min)
Arachidonic acid concentrations evaluated on the basis as change from baseline to calculate arachidonic acid area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in arachidonic acid from 0 min to 180 min (i.e., AUC (arachidonic acid 0 min- 0 min, arachidonic acid 30 min-0 min, arachidonic acid 60 min-0 min, etc)
Area under the curve for arachidonic acid for 3 hours (0, 30, 60, 90, 120 min)
8-isoprostaglandin-F2a/Arachidonic Acid
Periodo de tiempo: Area under the curve for 8-isoprostaglandin-F2a/arachidonic acid for 3 hours (0, 30, 60, 90, 120 min)
8-isoprostaglandin-F2a/arachidonic acid concentrations evaluated on the basis as change from baseline to calculate 8-isoprostaglandin-F2a/arachidonic acid area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in 8-isoprostaglandin-F2a/arachidonic acid from 0 min to 180 min (i.e., AUC (8-isoprostaglandin-F2a/arachidonic acid 0 min- 0 min, 8-isoprostaglandin-F2a/arachidonic acid 30 min-0 min, 8-isoprostaglandin-F2a/arachidonic acid 60 min-0 min, etc)
Area under the curve for 8-isoprostaglandin-F2a/arachidonic acid for 3 hours (0, 30, 60, 90, 120 min)
Nitric Oxide Metabolites (Nitrites/Nitrates) (NOx)
Periodo de tiempo: Area under the curve for NOx for 3 hours (0, 30, 60, 90, 120 min)
Biomarker of nitric oxide homeostasis is based on the assessment of total nitrite and nitrate concentrations. Changes relative to baseline were used to calculate area under the curve of total nitric oxide metabolites from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in nitric oxide homeostasis from 0 min to 180 min (i.e., AUC (NOx 0 min- 0 min, NOx 30 min-0 min, NOx 60 min-0 min, etc)
Area under the curve for NOx for 3 hours (0, 30, 60, 90, 120 min)
Arginine (Arg)
Periodo de tiempo: Area under the curve for arginine for 3 hours (0, 30, 60, 90, 120 min)
Arginine concentrations evaluated on the basis as change from baseline to calculate arginine area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in arginine from 0 min to 180 min (i.e., AUC (arginine 0 min- 0 min, arginine 30 min-0 min, arginine 60 min-0 min, etc)
Area under the curve for arginine for 3 hours (0, 30, 60, 90, 120 min)
Asymmetric Dimethylarginine/Arginine (ADMA/Arg)
Periodo de tiempo: Area under the curve for ADMA/Arg for 3 hours (0, 30, 60, 90, 120 min)
ADMA/Arg concentrations evaluated on the basis as change from baseline to calculate ADMA/Arg area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in ADMA/Arg from 0 min to 180 min (i.e., AUC (ADMA/Arg 0 min- 0 min, ADMA/Arg 30 min-0 min, ADMA/Arg 60 min-0 min, etc)
Area under the curve for ADMA/Arg for 3 hours (0, 30, 60, 90, 120 min)
Symmetric Dimethylarginine/Arginine (SDMA/Arg)
Periodo de tiempo: Area under the curve for SDMA/Arg for 3 hours (0, 30, 60, 90, 120 min)
SDMA/Arg concentrations evaluated on the basis as change from baseline to calculate SDMA/Arg area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in SDMA/Arg from 0 min to 180 min (i.e., AUC (SDMA/Arg 0 min- 0 min, SDMA/Arg 30 min-0 min, SDMA/Arg 60 min-0 min, etc)
Area under the curve for SDMA/Arg for 3 hours (0, 30, 60, 90, 120 min)
Angiotensin-II
Periodo de tiempo: Area under the curve for angiotensin-II for 3 hours (0, 30, 60, 90, 120 min)
Angiotensin-II concentrations evaluated on the basis as change from baseline to calculate angiotensin-II area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in angiotensin-II from 0 min to 180 min (i.e., AUC (angiotensin-II 0 min- 0 min, angiotensin-II 30 min-0 min, angiotensin-II 60 min-0 min, etc)
Area under the curve for angiotensin-II for 3 hours (0, 30, 60, 90, 120 min)
Endothelin-I
Periodo de tiempo: Area under the curve for endothelin-I for 3 hours (0, 30, 60, 90, 120 min)
Endothelin-I concentrations evaluated on the basis as change from baseline to calculate endothelin-I area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in endothelin-I from 0 min to 180 min (i.e., AUC (endothelin-I 0 min- 0 min, endothelin-I 30 min-0 min, endothelin-I 60 min-0 min, etc)
Area under the curve for endothelin-I for 3 hours (0, 30, 60, 90, 120 min)

Colaboradores e Investigadores

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

Patrocinador

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 enero de 2015

Finalización primaria (Actual)

1 de agosto de 2016

Finalización del estudio (Actual)

1 de junio de 2017

Fechas de registro del estudio

Enviado por primera vez

4 de febrero de 2015

Primero enviado que cumplió con los criterios de control de calidad

10 de febrero de 2015

Publicado por primera vez (Estimar)

18 de febrero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de mayo de 2019

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

1 de mayo de 2019

Última verificación

1 de mayo de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2014H0307 (Otro identificador: Ohio State University IRB)

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. .

Ensayos clínicos sobre Enfermedad cardiovascular

Ensayos clínicos sobre Glucose (100g)

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