Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins in Older Adults at Risk for Adverse Outcomes - a Pilot Study

Conditions
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Coronary Disease, Inflammation, Cognitive Impairment

Intervention / Treatment
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* Dietary Supplement: Anthocyanin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anthocyanin<br>34 patients will receive anthocyanin. We will analyze their blood samples both prior and after taking anthocyanin. | Dietary Supplement: Anthocyanin<br>* Open pilot study. 35 patients will receive anthocyanin 160 mg x 2 p.o for 16 weeks<br>* Other names: Medox;|
| No Intervention: Controls<br>Healthy Controls, 20 persons. Will be giving blood samples at study start and study end. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation as measured by cytokines in blood | IL1, IL6, IL10, TNFa | 16 weeks | 
| Effect on blood lipids as measured by serum Levels of Cholesterol, triglycerides, cholesterol metabolites | Serum Level measurement of Cholesterol, triglycerides, cholesterol metabolites | 16 weeks | 
| Effects on oxidative stress as measured by Blood Levels of lipid peroxidation markers, 4-hydroxymenal protein oxydation marker, total protein carbonyl | Blood Levels of lipid peroxidation markers, 4-hydroxymenal protein oxydation marker, total protein carbonyl | 16 weeks | 
| Effects on antioxidants as measured by Blood levels of vitamin E, vitamin C, vitamin A, total plasma antioxidant capacity, glutathion | Blood levels of vitamin E, vitamin C, vitamin A, total plasma antioxidant capacity, glutathion | 16 weeks | 
| Number of participants With adverse events | Active questioning for adverse events | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on memory (CERAD memory test) | CERAD memory test, immediate and delayed score | 16 weeks | 
| Effects on attention (Trail making A and B) | Trail making A and B | 16 weeks | 
| Effects on executive functioning (Stroop test) | Stroop test | 16 weeks | 
| Effects on blood pressure | Blood pressure (mm/Hg) in sitting position | 16 weeks | 
| Effects on heart rate (ECG) | ECG | 16 weeks | 
| Effect on Cardiac output (Blood Levels of natriuretic peptides) | Blood Levels of natriuretic peptides | 16 weeks |