Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins

Helse Stavanger HF

Status: Completed

Conditions: Inflammation; Cognitive Impairment; Coronary Disease

Treatments: Dietary Supplement: Anthocyanin

Study type: Interventional

Funder types: Other

Identifiers

NCT02409446

Antho 030

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 54 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Anthocyanin

Experimental group

Description:

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

Treatment:

Dietary Supplement: Anthocyanin

Controls

No Intervention group

Description:

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