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Completed

NCT Number: NCT02409446

Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins

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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Key information

Conditions

Coronary Disease Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Heart Diseases Inflammation Mental Disorders Myocardial Ischemia Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stavanger University Hospital

Stavanger, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anthocyanin

Dietary Supplement

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

Other names: Medox

Primary outcomes

  1. Inflammation as measured by cytokines in blood

    Time frame: 16 weeks

    IL1, IL6, IL10, TNFa

  2. Effect on blood lipids as measured by serum Levels of Cholesterol, triglycerides, cholesterol metabolites

    Time frame: 16 weeks

    Serum Level measurement of Cholesterol, triglycerides, cholesterol metabolites

  3. Effects on oxidative stress as measured by Blood Levels of lipid peroxidation markers, 4-hydroxymenal protein oxydation marker, total protein carbonyl

    Time frame: 16 weeks

    Blood Levels of lipid peroxidation markers, 4-hydroxymenal protein oxydation marker, total protein carbonyl

  4. Effects on antioxidants as measured by Blood levels of vitamin E, vitamin C, vitamin A, total plasma antioxidant capacity, glutathion

    Time frame: 16 weeks

    Blood levels of vitamin E, vitamin C, vitamin A, total plasma antioxidant capacity, glutathion

  5. Number of participants With adverse events

    Time frame: 16 weeks

    Active questioning for adverse events

Secondary outcomes

  1. Effects on memory (CERAD memory test)

    Time frame: 16 weeks

    CERAD memory test, immediate and delayed score

  2. Effects on attention (Trail making A and B)

    Time frame: 16 weeks

    Trail making A and B

  3. Effects on executive functioning (Stroop test)

    Time frame: 16 weeks

    Stroop test

  4. Effects on blood pressure

    Time frame: 16 weeks

    Blood pressure (mm/Hg) in sitting position

  5. Effects on heart rate (ECG)

    Time frame: 16 weeks

    ECG

  6. Effect on Cardiac output (Blood Levels of natriuretic peptides)

    Time frame: 16 weeks

    Blood Levels of natriuretic peptides

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Apr 6, 2015
Registry last updated
Feb 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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