Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins
Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins in Older Adults at Risk for Adverse Outcomes - a Pilot Study
The purpose of this study is to examine weather treatment with anthocyanins will affect lipid profile, markers of inflammation and oxidative stress in addition to antioxidative level in serum to the better in persons with increased risk of dementia.
The purpose of this study is to examine weather treatment with anthocyanins will increase the score of relevant tests of cognitive function.
The investigators will do an open pilot study where patients receive anthocyanin for 16 weeks. 34 patients are expected to be included.
In addition we will include 20 healthy Controls.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Design, method and material:
The investigators will first do an open pilot study where 30 people will receive anthocyanins for 16 weeks.
The investigators aim to recruit persons with increased risk of cognitive reduction: persons over 50 years with stable coronary heart disease (CAD) from the cardiology department Stavanger University Hospital. In addition will persons with mild cognitive impairment or mild dementia be included from the memory outpatient clinic, Stavanger University Hospital.
Blood will be taken by venepuncture by an experienced nurse, centrifuged and handled in according to standardized procedures.
The patients will be tested in relevant tests of cognitive function at inclusion and after 16 weeks. At inclusion the patients will be tested in Mini Mental State Examination (MMSE) and Geriatric depression scale (GDS) to make sure that the patients meet the inclusion criteria. At inclusion and after 16 weeks the patients will be tested in Word List Memory Word List Recall Word List Recognition, Trail Making Test A + B and Stroop Word and Colour test.
From the healthy controls blood will be taken at inclusion and study end.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Stavanger, Noruega
- Stavanger 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:
- Age above 50 years and coronary suspect chest pain with angiographically CAD without physiologically stenosis
- Mild cognitive impairment (ICD 10) or mild dementia, defined as fulfilling the dementia criteria (ICD 10) but with an MMSE score of 24 or higher.
- Stable medical treatment for the last 3 months.
Exclusion Criteria:
- Moderate to severe dementia (MMSE < 24)
- Clinical significant depression (GDS-15 score of 7 or higher)
- Unstable coronary heart disease
- Heart failure in need of treatment
- Inflammatory illnesses such at rheumatoid arthritis etc.
- Another severe illness with < 5 year expected survival time.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Anthocyanin
34 patients will receive anthocyanin.
We will analyze their blood samples both prior and after taking anthocyanin.
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Open pilot study.
35 patients will receive anthocyanin 160 mg x 2 p.o for 16 weeks
Otros nombres:
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Sin intervención: Controls
Healthy Controls, 20 persons.
Will be giving blood samples at study start and study end.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Inflammation as measured by cytokines in blood
Periodo de tiempo: 16 weeks
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IL1, IL6, IL10, TNFa
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16 weeks
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Effect on blood lipids as measured by serum Levels of Cholesterol, triglycerides, cholesterol metabolites
Periodo de tiempo: 16 weeks
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Serum Level measurement of Cholesterol, triglycerides, cholesterol metabolites
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16 weeks
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Effects on oxidative stress as measured by Blood Levels of lipid peroxidation markers, 4-hydroxymenal protein oxydation marker, total protein carbonyl
Periodo de tiempo: 16 weeks
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Blood Levels of lipid peroxidation markers, 4-hydroxymenal protein oxydation marker, total protein carbonyl
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16 weeks
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Effects on antioxidants as measured by Blood levels of vitamin E, vitamin C, vitamin A, total plasma antioxidant capacity, glutathion
Periodo de tiempo: 16 weeks
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Blood levels of vitamin E, vitamin C, vitamin A, total plasma antioxidant capacity, glutathion
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16 weeks
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Number of participants With adverse events
Periodo de tiempo: 16 weeks
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Active questioning for adverse events
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16 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Effects on memory (CERAD memory test)
Periodo de tiempo: 16 weeks
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CERAD memory test, immediate and delayed score
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16 weeks
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Effects on attention (Trail making A and B)
Periodo de tiempo: 16 weeks
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Trail making A and B
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16 weeks
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Effects on executive functioning (Stroop test)
Periodo de tiempo: 16 weeks
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Stroop test
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16 weeks
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Effects on blood pressure
Periodo de tiempo: 16 weeks
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Blood pressure (mm/Hg) in sitting position
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16 weeks
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Effects on heart rate (ECG)
Periodo de tiempo: 16 weeks
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ECG
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16 weeks
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Effect on Cardiac output (Blood Levels of natriuretic peptides)
Periodo de tiempo: 16 weeks
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Blood Levels of natriuretic peptides
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16 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dag Aarsland, Helse Stavanger HF
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- Antho 030
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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