Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-11-30

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.

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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.

Conditions

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Coronary Disease Inflammation Cognitive Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Anthocyanin

34 patients will receive anthocyanin. We will analyze their blood samples both prior and after taking anthocyanin.

Group Type EXPERIMENTAL

Anthocyanin

Intervention Type DIETARY_SUPPLEMENT

Open pilot study. 35 patients will receive anthocyanin 160 mg x 2 p.o for 16 weeks

Controls

Healthy Controls, 20 persons. Will be giving blood samples at study start and study end.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Anthocyanin

Open pilot study. 35 patients will receive anthocyanin 160 mg x 2 p.o for 16 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Medox

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes