Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins

Not Applicable

Completed

• Conditions: Coronary Disease; Cognitive Impairment; Inflammation
• Interventions: Dietary Supplement: Anthocyanin

• Registration Number: NCT02409446
• Lead Sponsor: Helse Stavanger HF

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-03-17
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-03
• Study First Posted: 2015-04-06
• Primary Completion: 2017-11
• Status Verified: 2017-12
• Study Completion: 2018-11
• Last Update Submitted: 2019-02-15
• Last Update Posted: 2019-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stavanger University Hospital; 🇳🇴 Stavanger, Norway