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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anthocyanin | Experimental | 34 patients will receive anthocyanin. We will analyze their blood samples both prior and after taking anthocyanin. |
|
| Controls | No Intervention | Healthy Controls, 20 persons. Will be giving blood samples at study start and study end. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anthocyanin | Dietary Supplement | Open pilot study. 35 patients will receive anthocyanin 160 mg x 2 p.o for 16 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dag Aarsland | Helse Stavanger HF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stavanger University Hospital | Stavanger | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31244884 | Derived | Bergland AK, Soennesyn H, Dalen I, Rodriguez-Mateos A, Berge RK, Giil LM, Rajendran L, Siow R, Tassotti M, Larsen AI, Aarsland D. Effects of Anthocyanin Supplementation on Serum Lipids, Glucose, Markers of Inflammation and Cognition in Adults With Increased Risk of Dementia - A Pilot Study. Front Genet. 2019 Jun 11;10:536. doi: 10.3389/fgene.2019.00536. eCollection 2019. |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D007249 | Inflammation |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000872 | Anthocyanins |
| ID | Term |
|---|---|
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| 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 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |