ChocolateDark Chocolate and Cocoa Ingestion and Endothelial Function: A Randomized, Placebo Controlled, Cross-over Trial
Chocolate
Estudio de Prevención
Resumen
Fecha de inicio: 1 de agosto de 2005
Fecha en la que se inscribió al primer participante.Endothelial function has been used extensively to evaluate the acute and chronic effects of foods and nutrients on cardiac risk and can provide a direct measurement of the effect of cocoa powder consumption on vascular physiology in healthy adults with BMI between 25-35 kg/m2. To our knowledge, our study is the first to examine the dose response effects of sugar free, liquid, cocoa and solid, dark chocolate with sugar consumption on FMD, concentrating on individuals with elevated BMI. Given the current epidemic of obesity in the United States; its role as a risk factor in the development of cardiovascular disease; and the fact that cardiovascular disease is the leading cause of mortality in this country, examination of the cardio-protective effects of cocoa or dark chocolate in an at risk population is of considerable potential interest. Demonstrating that ingestion of cocoa may reverse damage caused to the endothelium may lead to new dietary recommendations that may help curb the prevalence of heart disease in the U.S.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 45 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 30 a 75 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
Inclusion Criteria: * Ages between 30 -75 * BMI between 25-35 kg/m2 * waist circumference above 88 cms. in women and 102 cms. in men * non-smoker * no strenuous exercise at least 8 hours prior to scanning * to facilitate recruitment individuals with diagnosed hypertension or hyperlipidemia will be included provided that they have been stable on their medications for three months, and can refrain from taking their medication 12 hours prior to BARS testing. Exclusion Criteria: * Failure to meet inclusion criteria * anticipated inability to complete study protocol for any reason * current eating disorder * diagnosed coronary artery disease * diabetes * sleep apnea * current or impending pregnancy * insulin or glucose sensitizing medication use, vasoactive medication or nutriceutical use (glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) * regular use of high dose vitamin E or C and unable to discontinue for duration of the study * regular use of fiber supplements and unable to discontinue for duration of the study * restricted diets by choice (i.e. vegan, Atkins diet etc) * allergy to cocoa or chocolate.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.3 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalGrupo III
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación