Effects of a Spiced Meat Patty on Inflammation in Men With Type 2 Diabetes
Inhibition of Absorption of Cytoxic Lipid Peroxidation Products and Abnormalities of Postprandial Endothelial Function by Spice Polyphenols Fed Together With High Fat Meat Patty in Men With Type 2 Diabetes Mellitus or Impaired Glucose Tolerance
Polyphenols belong to the largest group of secondary metabolites produced by plants, mainly, in response to biotic or abiotic stresses such as infections, wounding, UV irradiation, exposure to ozone, pollutants, and other hostile environmental conditions. It is thought that the molecular basis for the protective action of polyphenols in plants is their antioxidant and free radical scavenging properties. These numerous phenolic compounds are major biologically active components of spices, aromas, essential oils, and traditional medicines. In order to investigate the impact of spice polyphenols on postprandial flow-mediated dilation, nitric oxide, glucose, insulin, triglycerieds, oxidized LDL, and cytoxic lipid peroxidation products (MDA) levels in men with type 2 diabetes, the investigators propose to achieve the following specific aims using a randomized crossover study design:
- To determine the effect of a ground beef patty meal with and without polyphenol-rich spices on postprandial levels of plasma oxidized LDL, triglycerides, insulin, glucose, and malondialdehyde (MDA).
- To determine the effect of a ground beef patty meal with and without polyphenol-rich spices on postprandial levels of nitric oxide and flow-mediated dilation.
- To determine the effect of a ground beef patty meal with and without a spice blend on MDA accumulation in urine.
This study will determine whether spice polyphenols exert a beneficial effect by inhibition of the absorption of lipotoxin MDA in males with type 2 diabetes mellitus.Men with diabetes mellitus type 2 have been selected for this study to enable assessment of markers of vascular health including nitric oxide in plasma and flow-mediated dilation. These findings may help to explain the potentially harmful effects of oxidizable fats found in foods and the important benefit of dietary polyphenols in ameliorating this potentially harmful effect.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90095
- David Geffen School of Medicine, UCLA Center for Human Nutrtiion
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Have a diagnosis of Type II Diabetes Mellitus and currently being treated with oral medication but no insulin or glucose intolerant on no medications with a fasting blood sugar of > 110 mg/dl but less than 126 mg/dl fasting.
- Have an HbA1C lvel <9 % at Screening
- Male 35-70 years old
- Non-smokers, or smoke < 1 cigarette per day
- Must weigh a minimum of 110 pounds
- Willing to maintain normal activity and eating patterns for the duration of the study
- Willing to avoid meat, fish or poultry for three days on two occasions prior to the test procedure
- Consuming less than two alcoholic drinks per day
- Not taking dietary supplements
- No known allergy to beef, cloves, cinnamon, oregano, turmeric, cumin, rosemary, sage, red pepper, ginger, black pepper, paprika or garlic
Exclusion Criteria:
- Currently using insulin
- Abnormal liver function
- Currently taking steroidal drugs
- Known HIV positive or AIDS
- Chronic infectious disease
- Cancer treated within the past two years
- Participation in a therapeutic research study within 30 days of baseline
- Allergy to beef, cloves, cinnamon, oregano, rosemary, ginger, black pepper, paprika or tumeric
- History of hear failure with EF < 30, chronic renal failure with GFR < 30 ml/min
- Currently taking vasoactive medications such as but not limited to calcium channel blockers, nitrates, beta blockers, phosphodiesterase inhibitors
- History of Raynauds
- History of smoking within 5 years
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Spice patty
hamburger meat cooked with spice mixture
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spice
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Comparador de placebos: salt patty
Subjects consume salt containing hamburger meat
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spice
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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The protocol is designed to study the effect of spice on MDA production in hamburg meat
Periodo de tiempo: 2 days
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2 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Zhaoping Li, MD, University of California, Los Angeles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 08-11-023
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