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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Stavanger, Noruega
- Stavanger University Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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
Outros nomes:
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Sem intervenção: Controls
Healthy Controls, 20 persons.
Will be giving blood samples at study start and study end.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Inflammation as measured by cytokines in blood
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 16 weeks
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Active questioning for adverse events
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16 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Effects on memory (CERAD memory test)
Prazo: 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)
Prazo: 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)
Prazo: 16 weeks
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Stroop test
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16 weeks
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Effects on blood pressure
Prazo: 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)
Prazo: 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)
Prazo: 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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Antho 030
Plano para dados de participantes individuais (IPD)
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