ButCoIns - Metabolic Effects of Resistent Starch and Arabinoxylans in Subjects With Metabolic Syndrome (ButCoIns)
Background Life style related disease is an increasing problem all over the world. The Metabolic Syndrome (MetS) is a condition characterized by abdominal obesity, high blood lipids, high blood pressure and slightly elevated blood sugar. Subjects with MetS have high risk of developing Type 2 Diabetes and cardiovascular disease.
Dietary fibers have been shown to have positive effects on the components of MetS. The investigators have special interest in the combination of two types of fiber (Resistant (RS) starch and Arabinoxylans (AX)) .
Hypotheses Increase of RS and AX in the dietary composition has a positive effects on components of MetS i.e. decreases blood lipids, improves blood sugar, blood pressure and markers of inflammation.
The subjects undergo two dietary interventions of 4 weeks duration each: A "Healthy Carbohydrate Diet" with a high content of RS and AX is compared to a "Western Style Diet" with a low content of RS and AX.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background Life style related disease is an increasing problem all over the world. The Metabolic Syndrome (MetS) is a condition characterized by abdominal obesity, dyslipidemia, hypertension and impaired glucose tolerance. Subjects with MetS have high risk of developing Type 2 Diabetes and CVD.
Resistant Starch (RS) and Arabinoxylans (AX) are dietary fibers that have been shown to have positive effects on the components of MetS. The combination of RS and AX has not been tested before .
Hypotheses Increase of RS and AX in the dietary composition has a positive effects on components of MetS i.e. decreases postprandial lipaemia, improves glucose tolerance, insulin resistance, blood pressure and markers of inflammation.
Design:
A nonblinded randomized cross over study Two dietary interventions of 4 weeks duration each. A healthy carbohydrate Diet with a high content of RS and AX is compared to a Western Style diet with a low content of RS and AX. Between the two interventions, there is a wash out period of 4 weeks.
The primary outcome is postprandial lipaemia estimated by a high fat meal test of 6 hours duration. The test is performed before and after each intervention.
Secondary outcomes are:
- Glucose tolerance and insulin resistance estimated by OGTT
- 24 hours blood pressure
- MRI estimation of liver fat content
- Postprandial changes in genes of adipose tissue
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Aarhus, Dinamarca, 8000
- Aarhus University Hospital
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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: At least 3 out of the 5 following criterions
- Central obesity (Female >80 cm, Male >94)
- HDL cholesterol (female < 1,03 mmol/l, male < 1,29 mmol/l)
- Blood Pressure (> 130/85)
- Fasting Blood Glucose > 5,6 mmol/L
Exclusion Criteria:
- Diabetes
- Gastrointestinal disease
- Anticoagulation treatment
- Serious liver, heart or kidney disease
- Anaemia
- Corticosteroid treatment
- Waist circumference above 130 cm
- Alcohol or drug addiction
- Pregnancy og lactation
Plan de estudios
¿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 |
|---|---|
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Comparador activo: Healthy Carbohydrate Diet
4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch.
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Cross over study with two intervention diets.
Healthy Carbohydrate Diet with approximally 55 g of dietary fibers (arabinoxylan and resistant starch)compared with western style diet with low content of dietary fibers.
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Comparador de placebos: Western Style Diet
4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans
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Cross over study with two intervention diets.
Healthy Carbohydrate Diet with approximally 55 g of dietary fibers (arabinoxylan and resistant starch)compared with western style diet with low content of dietary fibers.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postprandial triglycerides
Periodo de tiempo: 4 weeks
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Plasma Triglycerides are estimated during a high fat meal test of 6 hours duration.
The test is performed before and after each intervention of 4 weeks.
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4 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in insulin sensitivity
Periodo de tiempo: 4 weeks
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-Estimated by an OGTT where glucose and insulin are measured several times and insulin sensitivity is estimated according to the Matsuda Index.
The test is performed before and after each intervention of 4 weeks.
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4 weeks
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Metabolic Rate
Periodo de tiempo: 4 weeks
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The metabolic rate is measured by indirect calometri (Deltatrac II) in the fasting state and two hours after ingestion of a fatty mixed meal.
The test is performed before and after each intervention period.
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4 weeks
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Body composition
Periodo de tiempo: 4 weeks
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H-MRS of liver before and after intervention in order to estimate the fat content.
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4 weeks
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Twenty-Four-Hour Blood Pressure
Periodo de tiempo: 4 weeks
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Performed in the free-living situation.
Data analysis are grouped in mean day, mean night and mean 24 h.
Measured at baseline and at the end of each intervention.
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4 weeks
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Gene expression in adipose tissue
Periodo de tiempo: Four weeks
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Fat biopsies are take from abdominal adipose tissue and analyzed by real time PCR to see if gene expression changes after a high intake of dietary fiber.
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Four weeks
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Inflammatory Markers after 4 weeks of intervention
Periodo de tiempo: 4 weeks
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hs CRP, IL-6 and adiponectin are measured at baseline and at the end of each intervention.
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4 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CERN-ButCoIns
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