The Influence of Daily Intake of Whole Grain Barley or Oats on Biomarkers of Cardiovascular Disease
13 de octubre de 2011 actualizado por: United States Department of Agriculture (USDA)
The objectives of this study are the following: 1) to determine the effect of daily consumption of whole grain barley for six week on risk factors of cardiovascular disease compared to a diet low in whole grains, and 2) to compare the effects of daily consumption of whole grain barley to those of whole grain oats for six weeks to determine if the response to these two grains is different.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
69
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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Maryland
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Beltsville, Maryland, Estados Unidos, 20705
- USDA Beltsville Human Nutrition Research Center
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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
25 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Men and women between the ages of 25-70 years
- Body mass index (BMI) ≥ 19 and ≤ 38
- Willingness and ability to make scheduled appointments at clinical site as required by study protocol
Exclusion Criteria:
- Do not regularly consume breakfast or dislike cereal for breakfast
- Known (self-reported) allergy or adverse reaction to grains (e.g., wheat, gluten, barley)
- Presence of kidney disease, liver disease, gout, untreated or unstable hypothyroidism, untreated or unstable hyperthyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- Fasting triglycerides > 300 mg/dL
- Fasting glucose > 126 mg/dL
- Use of cholesterol lowering medication
- Blood pressure > 180/100 or hypertension treated with calcium channel blockers, direct acting vasodilators, or beta blockers
- History of bariatric or certain other surgeries related to weight control
- History of major surgery within 3 months of enrollment
- Smokers or other tobacco users (during 6 months prior to the start of the study)
- Antibiotic use during the intervention or for 3 months prior to the intervention period
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
- Volunteers who have lost 10% of body weight within the last 6 months
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Whole Grain Barley Diet
A controlled diet containing at least 4 daily servings of whole grain barley.
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Subjects will be randomly assigned to one of three treatments: 1) a control diet containing 0.7 daily servings of whole grain, 2) a diet containing at least 4 daily servings of whole grain barley or 3) a diet containing at least 4 servings of whole grain oats.
After 6 weeks, risk factors of cardiovascular disease will be assessed after a 12 hr fast.
During the seventh week, risk factors of cardiovascular disease will be assessed in the postprandial state.
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Comparador activo: Whole Grain Oats Diet
A diet containing at least 4 servings of whole grain oats.
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Subjects will be randomly assigned to one of three treatments: 1) a control diet containing 0.7 daily servings of whole grain, 2) a diet containing at least 4 daily servings of whole grain barley or 3) a diet containing at least 4 servings of whole grain oats.
After 6 weeks, risk factors of cardiovascular disease will be assessed after a 12 hr fast.
During the seventh week, risk factors of cardiovascular disease will be assessed in the postprandial state.
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Otro: Low Whole Grain Diet
A control diet containing 0.7 daily servings of whole grain.
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Subjects will be randomly assigned to one of three treatments: 1) a control diet containing 0.7 daily servings of whole grain, 2) a diet containing at least 4 daily servings of whole grain barley or 3) a diet containing at least 4 servings of whole grain oats.
After 6 weeks, risk factors of cardiovascular disease will be assessed after a 12 hr fast.
During the seventh week, risk factors of cardiovascular disease will be assessed in the postprandial state.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Meal Tolerance Assessment
Periodo de tiempo: 7 hours
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Subjects will provide a baseline blood sample at 15 minutes and 5 minutes prior to consuming a test meal.
Subjects will then consume a high fat breakfast of foods such as eggs, buttered English muffins, and donuts.
Blood samples will be collected 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, and 420 min following ingestion of the test meal.
Measurements will be made for serum triglyceride area under the curve, serum cholesterol, insulin, glucose, and plasma apo B48.
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7 hours
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Biomarkers of cardiovascular risk
Periodo de tiempo: After a 12 hour fast
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Fibrinogen, factor VII, blood pressure, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, Lp(a), and lipoprotein size.
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After a 12 hour fast
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Biomarkers of oxidative stress
Periodo de tiempo: After 6 weeks of feeding
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Nitrites and nitrates, malondialdehyde, lipid hydroperoxides, ox-LDL, resistance of LDL to Cu2+-induced oxidation, FRAP, glutathione, glutathione-S-transferase, super oxide dismutase, PON-1, betaine, homocysteine, total thiols, urinary isoprostanes.
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After 6 weeks of feeding
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Biomarkers of inflammation
Periodo de tiempo: After 6 weeks of controlled feeding
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C-reactive protein (CRP), IL-6, IL-8, IL-10, IL-18, TNFα, matrix metalloproteinases (MMP-2, MMP-9), e-Selectin, ICAM, VCAM
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After 6 weeks of controlled feeding
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Biomarkers of glucoregulatory control
Periodo de tiempo: After 6 weeks of feeding
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Glycated apolipoprotein B, hemoglobin A1c, fructosamine, insulin, glucose, leptin, adiponectin
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After 6 weeks of feeding
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Genotype testing
Periodo de tiempo: After 6 weeks of controlled feeding
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Blood will be used to test for genetic traits that may influence nutrient metabolism and also traits reflecting the mechanisms that may be influenced by the intervention.
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After 6 weeks of controlled feeding
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Microarray and targeted gene expression testing
Periodo de tiempo: After 6 weeks of controlled feeding
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Blood samples will be used to test how the intervention affects gene expression.
Global gene expression will be performed for a complete survey of the RNA response to the intervention.
Targeted gene expression will be performed to confirm the findings of the global gene expression analysis.
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After 6 weeks of controlled feeding
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Janet A Novotny, PhD, USDA Beltsville Human Nutrition Research Center
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.
Enlaces Útiles
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 mayo de 2011
Finalización primaria (Actual)
1 de agosto de 2011
Finalización del estudio (Actual)
1 de agosto de 2011
Fechas de registro del estudio
Enviado por primera vez
8 de febrero de 2011
Primero enviado que cumplió con los criterios de control de calidad
9 de febrero de 2011
Publicado por primera vez (Estimar)
10 de febrero de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
14 de octubre de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
13 de octubre de 2011
Última verificación
1 de octubre de 2011
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HS34
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